Approved Clinical Trials This page provides a searchable list of all clinical trial research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology (UNCST).
Search By Approval Date:
Clear Filter Total: 323
Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
Waiswa Peter
ID: UNCST-2020-R014921
 An effectiveness-implementation trial of a peer mentorship intervention to help women navigate barriers to contraceptive use in rural Uganda
REFNo: HS7355ES

Main objective
: Our main aim is to increase women’s ability to overcome barriers to contraceptive use and to support adoption of self-injectable contraception. After promising findings in our pilot study, we propose to build on our strong, ongoing partnership between Makerere University in Uganda and the University of California, San Francisco to test “I-CAN” intervention on a larger scale.
Objectives
1. To test the effectiveness of a peer mentorship intervention on contraceptive use and contraceptive self-injection (Aim 1).
2. To examine the process of implementing I-CAN intervention; the ICAN’s reach to mentees, differential effectiveness, adoption and maintenance by mentors, implementation fidelity and innovations, and contextual factors (Aim 2)
3. To examine the cost-effectiveness of the peer mentorship intervention versus standard of care (counselling by health facility or community health workers) in supporting contraceptive use and contraceptive self-injection (Aim 3).

Iganga, Yet to be selectedYet to be selecetd
Kole, Yet to be selecetd
 Uganda 2026-04-02 12:45:33 2029-04-02 The trial is powered for all outcomes. 26 villages per arm (52 total clusters) with a cluster size of 30 households (total N=1,560 households at each timepoint) will allow us ≥80% power (alpha=0.05) to detect the following effect sizes among women ages 18-49 between arms at 24- months: The primary study population will include women ages 18-49 years form Iganga and Kole districts; Basoga nd langi tribes National Institutes for Health Medical and Health Sciences Clinical Trial Non-degree Award
Victoria Ndyanabangi
ID: UNCST-2021-R012645
 IMPAACT 2024- Protocol Titled: Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined with Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age with and without HIV. DAIDS Study ID #38747,IND #171439
REFNo: HS6638ES

To determine weight-band dosing of a once-daily, 28-day regimen of isoniazid (INH) and rifapentine (RPT) (1HP) for the prevention of tuberculosis (TB) in children living with and without HIV.

Primary Objectives
Cohort 1 and Cohort 2
To determine the weight-band dosing of RPT taken as part of the 1HP regimen by evaluating:
⎯ PK RPT exposures among children with and without HIV
⎯ Safety and tolerability of the 1HP regimen among children with HIV while receiving twice-daily
DTG and children without HIV through 28 days of dosing

Cohort 2
• To evaluate the effect of RPT taken as part of the 1HP regimen on the PK of DTG
Secondary Objectives
Cohort 1 and Cohort 2
To evaluate the effect of covariates including age, weight, sex, ethnicity, nutritional status, and HIV-1 status on the PK of RPT taken as part of the 1HP regimen
• To evaluate the safety of the 1HP regimen through 24 weeks of follow-up
• To evaluate the palatability and acceptability of the 1HP regimen
• To evaluate adherence to the 1HP regimen

Cohort 2
• To evaluate the safety and tolerability of twice-daily DTG through 42 days among children with HIV who are receiving 1HP
• To evaluate virologic control (less than 200 copies/mL) at Day 42 among children taking a DTG-Based ARV treatment regimen co-administered with 1HP

Kampala, All Parishes
 Uganda 2026-03-30 12:54:54 2029-03-30 48 Children living without HIV (Cohort 1) and children living with HIV (Cohort 2) at risk of TB disease who are less than 13 years of age. Children in Cohort 2 will receive an antiretroviral (ARV) treatment regimen containing dolutegravir (DTG). National Institute of Allergy and Infectious Diseases Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute of Mental Health Medical and Health Sciences Clinical Trial Non-degree Award
Monicah Agaba
ID: UNCST-2024-R004221
 The effect of a peer modelled complex behavioural change intervention on the cardio-metabolic health of women in Mbarara City, Uganda
REFNo: HS7211ES

1. To assess the effect of the a complex behavioural change intervention on the central adiposity of the WRA.,To evaluate the overall effectiveness of a peer modelled complex behavioural change intervention on the cardio-metabolic health of women through a cluster randomised control trial.,
 Mbarara, Kakoba
 Uganda 2026-03-25 10:44:24 2029-03-25 157 18 to 49 years Women of reproductive age All tribes Residents of Kakoba Ward within Mbarara City Katholieke Universiteit Leuven Medical and Health Sciences Clinical Trial Degree Award
Abdul Malik Muwanga
ID: UNCST-2026-R024094
 Developing Leadership Skills of ECCE Center Management Committees in Palorinya Refugee Hosting ECCE centers - Obongi District
REFNo: SS5010ES

1 Identify gaps in the leadership skills of CMCs in refugee hosting ECCEcenters in Palorinya refugee settlement.
2 Develop a training program to strengtheb the leadership skills of CMCs in enhancing children’s learning outcomes in Palorinya refugee settlement.
3 Implement a training program to develop the leadership skills of CMCs to improve children’s learning outcomes in refugee-hosting ECCE centers in Palorinya.
4 Evaluate the effectiveness of a training program in developing the leadership skills of ECCECenter Management Committees to improve children’s learning outcomes in Palorinya refugee settlement.
5 Generate principles to guide the development and implementation of training programs for developing the leadership skills of CMCs to improve children’s Early Learning Outcomes (ELOs) in ECCEcenters in related poly-crisis contexts.

 Moyo, Palorinya
 Uganda 2026-03-24 8:59:47 2029-03-24 90 90 participants drawn from 10 Early Childhood Care and Education (ECCE) centers located within Palorinya Refugee Settlement, encompassing a range of institutional types 3 supported by UNHCR, 2 by Save the Children International, and 5 community-managed (ChildFund Alliance, 2022). Self Sponsored Social Science and Humanities Clinical Trial Degree Award
Dennis Muhanguzi
ID: UNCST-2019-R001101
 Evaluation of The Safety, Efficacy and Stability of SangaDelta® Emulsifiable Concentrate [E.C]: A Randomised Single-Blinded Positive Controlled Multi-Site Acaricide Field Trial
REFNo: NS1194ES

General objectives
To determine the efficacy, safety, and stability of SangaDelta® (Sanga Vet. Chem. Ltd, Kampala Industrial Park, Namanve ) when applied onto cattle by hand spraying and plunge dipping for tick control.

Specific objectives
The specific objectives of this acaricide field trial will to determine:
i.Efficacy of SangaDelta® when applied onto cattle by hand spraying and plunge dipping for tick control.
ii.Safety of SangaDelta® when applied onto cattle by hand spraying and plunge dipping for tick control.
iii.Stability of SangaDelta® when applied onto cattle by plunge dipping for tick control.

Mayuge, Lwanika
Mayuge, Buyemba
Mayuge, Lukone
Kumi, Boma
Serere, Okidi
Serere, Akumoi
Uganda 2026-03-19 16:13:37 2029-03-19 500 cattle above 3 months of age of box sexes and all breeds at the six participating farms The study population will constitute cattle of any breed owned by 6 participating farmers in Mayuge [3 farmers], Kumi [one Farmer] and Serere [2 Farmers] district. A total of 500 cattle above 3 months of age will be recruited. Both female, male and neutered cattle will be enrolled into the study Sanga Vet. Chem. Ltd P.O Box 75164 | Plot 1144, Kampala Industrial Business Park | Kampala-Uganda Tel: 02008000100 | Web: https://www.sangavetchem.com/ Natural Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 A Phase 2A study to evaluate the safety, tolerability and pharmacokinetics of a novel antimalarial pyrrolidinamide at different doses and dose durations, in adult patients with uncomplicated P. falciparum malaria
REFNo: HS7237ES

Primary objective:
To investigate the safety and tolerability of GSK3772701 after single and repeat oral doses in adult patients with uncomplicated P. falciparum malaria.
Secondary objectives
To evaluate the PK profile of single and repeat oral doses of GSK3772701 in adult patients with
uncomplicated P. falciparum malaria.

Exploratory objectives.
1. To evaluate the efficacy of single and repeat oral doses of GSK3772701 in adult patients with uncomplicated P. falciparum malaria.
2. To characterize the PK/PD relationship.
3. To evaluate P. falciparum genetic polymorphisms and potency of GSK3772701.
4. To assess the safety of GSK3772701 for individual parameters after single and repeat oral doses in adult patients with uncomplicated P. falciparum malaria

 Tororo, Whole district
 Uganda 2026-03-19 16:01:49 2029-03-19 A total of approximately 70 adult patients, with uncomplicated P. falciparum mono-infection, will be enrolled into the study across 5 cohorts Male and female patients aged 18 to 65 years. GlaxoSmithKline Research & Development Limited, 79 New Oxford Street, London WC1A 1DG, United Kingdom. Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Muhanguzi
ID: UNCST-2019-R001101
 Evaluation of The Safety, Efficacy and Stability of Sangaphos® Emulsifiable Concentrate [E.C]: A Randomised Single-Blinded Positive Controlled Multi-Site Acaricide Field Trial
REFNo: NS1171ES

General objectives: To determine the efficacy, safety, and stability of SangaPhos [Sanga Vet. Chem. Ltd, Kampala Industrial Park, Namanve] when applied onto cattle by hand spraying and plunge dipping for tick control. Specific objectives The specific objectives of this acaricide field trial will to determine; i.Efficacy of Sangaphos® when applied onto cattle by hand spraying and plunge dipping for tick control. ii.Safety of Sangaphos® when applied onto cattle by hand spraying and plunge dipping for tick control. iii.Stability of Sangaphos® when applied onto cattle by plunge dipping for tick control.
Kyenjojo, Ntuutu
Kyenjojo, Bwenzi
Kyenjojo, Hima
Serere, Aarapoo
Serere, Aswii
Kumi, Kachaboi
Uganda 2026-03-03 12:23:56 2029-03-03 633 Six Cattle farms from Kyenjojo [n=3], Kumi [n=01] and Serere each with at least 66 cattle will be recruited. Total number of cattle at the six farms = 633. The animals will be at least 2 months of age. Both sexes and any cattle breeds on these farms will be recruited. Sanga Vet. Chem. Ltd P.O Box 75164 | Plot 1144, Kampala Industrial Business Park | Kampala-Uganda Tel: 02008000100 | Web: https://www.sangavetchem.com/ Natural Sciences Clinical Trial Non-degree Award
Susan  Nabadda
ID: UNCST-2020-R014331
 CLINICAL PERFORMANCE EVALUATION (RETROSPECTIVE STUDY) OF THE STANDARD Q HIV/SYPHILIS/HBsAg TRIPLE TEST
REFNo: HS6651ES

Quantify the proportion of uninterpretable (Invalid) results to gauge operational feasibility based on the invalid rate.,Assess Inter-reader Variability among different operators to ensure consistency in test interpretation and hence reliability in real-world settings.,To assess the diagnostic accuracy of the STANDARD Q HIV/Syphilis/HBsAg Triple Test, a rapid chromatographic immunoassay for simultaneous detection of HIV-1/2 antibodies, syphilis (Treponema pallidum) antibodies, and hepatitis B surface antigen (HBsAg). ,
 Kampala, National Health Laboratory and Diagnostic Service, Ministry of Health
 Uganda 2026-02-12 13:03:06 2029-02-12 Sample sizes for each disease analyte are calculated to achieve 95% confidence intervals with ±5% margin of error for sensitivity/specificity estimates. Clinical performance will follow the WHO TSS-1, TSS-6 and TSS-13 which require a sample size of up to 1000 samples; to achieve a pre-test clinical performance assessment of the HIV/Syphilis/HBsAg rapid diagnostic test kit, 50 samples of each disease analyte category will be used. Stored samples for 18 years and above for both males and females for all tribes will be considered. This retrospective study shall use archived samples from the CPHL biorepository with proof that at the time of sample collection, the source of the selected sample signed a broad consent indicating acceptance of storage for future research use of the remnant of their collected sample. Samples shall be selected from already known specific disease-characterized sets of positive and negative HIV, Syphilis and HBsAg. Department of National Health Laboratory and Diagnostic Service, Ministry of Health Medical and Health Sciences Clinical Trial Non-degree Award
Pauline Amuge Mary
ID: UNCST-2023-R005532
 Bedaquiline Roll-out Evidence in Contacts and People Living with HIV to prevent TB (BREACH-TB)
REFNo: HS6975ES

2.1.1.To estimate the safety of 1BDQ and 3HP among
adult, adolescent, and child CCs of DS-TB Index
Patients at high risk of developing TBD, as well
as adult and adolescent PLHIV in high TB burden settings

2.1.2To estimate the safety of 1BDQ and 6 months of
levofloxacin (LFX) among adult, adolescent, and
child CCs of RR-TB Index Patients at high risk of
developing TBD
2.1.3 To estimate on-time treatment completion of
1BDQ and 3HP among adult, adolescent, and
child CCs of DS-TB Index Patients at high risk of
developing TBD, as well as adult and adolescent
PLHIV in high TB-burden settings
2.1.4To estimate on-time treatment completion of
1BDQ and 6 months of levofloxacin (LFX)
among adult, adolescent, and child CCs of RRTB Index Patients at high risk of developing TBD
 Wakiso, Ssabagabo
 Uganda 2026-02-05 22:05:22 2029-02-05 3130 High-risk close contacts (CC) of an individual diagnosed with DS- or RR-TBD (i.e., the Index Patient) and PLHIV in high-TB burden regions United States Agency for International Development Medical and Health Sciences Clinical Trial Non-degree Award
AGNES NAGGIRINYA BWANIKA
ID: UNCST-2019-R001126
 Evaluating the impact on 90-day survival of post-discharge follow-up strategies delivered to adult patients hospitalized with sepsis across a research network in sub-Saharan Africa [Call for Life – Sepsis (C4L-Sepsis)]
REFNo: HS6882ES

To compare baseline demographic and clinical characteristics between participants who were randomized and those who did not meet randomization criteria (screen failures),To evaluate participant quality of life at 28- and 90-days post discharge period within two study arms.,To evaluate the proportion of participants within the two study arms who require re-admission to hospital during the post-discharge period of 90 days,To evaluate proportion of participants within the two study arms who return for scheduled post discharge follow-up visits ,To evaluate the efficacy on 28-day mortality among participants hospitalized with sepsis randomized to receive one of two post discharge follow-up strategies – EDI versus EDI plus IVR tool,To evaluate the efficacy on 90-day post-discharge mortality among adult participants hospitalized with sepsis randomized to receive one of two post discharge follow-up strategies – EDI versus EDI plus IVR tool,III. To train clinical officers about vitamin D and its application in managing the co-morbidity illnesses under study. This involves training and mentoring of clinical officers so as to acquire knowledge about vitamin D especially in relation to its clinical effects and treatment of malaria, diabetes, HTN, UTIs, and post covid-19 syndrome. This will enable build enough human capacity and willingness to carry out more research about vitamin D.,To develop prototypes of the efficacy doses of vitamin D for each co- morbidity group. From objective II, the efficacy doses (values) of vitamin D will be recorded. Vitamin D prototypes containing different formulations for each co-morbidity illness will be developed. These will be in form of; solutions, powder and inhalers,To establish the efficacy of vitamin D to the co-morbidity illnesses. This involves giving different doses of vitamin D to study participants in each co- morbidity group in addition to the illness’ conventional drugs while monitoring for change using the monitors of change tests/investigations to ascertain these therapeutic effects of Vitamin D.,To develop prototypes of the efficacy doses of vitamin D for each co-morbidity group. ,To explore vitamin D’s therapeutic efficacy to the co-morbidity diseases (malaria, HTN, diabetes, UTIs and post covid-19 syndrome) under study,III. To train clinical officers about vitamin D and its application in managing the co-morbidity illnesses under study. ,II. To develop prototypes of the efficacy doses of vitamin D for each co-morbidity group,I. To establish the efficacy of vitamin D to the co-morbidity illnesses,To explore vitamin D’s therapeutic efficacy to the co-morbidity diseases (malaria, HTN, diabetes, UTIs and post covid-19 syndrome) under study. ,III. To train clinical officers about vitamin D and its application in managing the co-morbidity illnesses under study. This involves training and mentoring of clinical officers so as to acquire knowledge about vitamin D especially in relation to its clinical effects and treatment of malaria, diabetes, HTN, UTIs, and post covid-19 syndrome. This will enable build enough human capacity and willingness to carry out more research about vitamin D,II. To develop prototypes of the efficacy doses of vitamin D for each co-morbidity group. From objective II, the efficacy doses (values) of vitamin D will be recorded. Vitamin D prototypes containing different formulations for each co-morbidity illness will be developed. These will be in form of; solutions, powder and inhalers ,I. To establish the efficacy of vitamin D to the co-morbidity illnesses. This involves giving different doses of vitamin D to study participants in each co-morbidity group in addition to the illness’ conventional drugs while monitoring for change using the monitors of change tests/investigations to ascertain these therapeutic effects of Vitamin D.,To explore vitamin D’s therapeutic efficacy to the co-morbidity diseases (malaria, HTN, diabetes, UTIs and post covid-19 syndrome) under study. This will be achieved by clinical application of vitamin D, assessing and monitoring its effect in the treatment of the respective comorbidity illness as well as developing of different formulations of vitamin D that had effect in each co-morbidity group. ,
 Masaka, Kimanya
Kampala, Mulago 1
 Uganda 2026-01-30 19:36:32 2029-01-30 353 Male and Female adults ≥18 years of all tribes who can understand English and Luganda. Stephen Okoboi Medical and Health Sciences Clinical Trial Non-degree Award
Isabelle Cohen
ID: UNCST-2025-R020977
 Evaluating a “nearly free hour” for health centers in rural Uganda
REFNo: SS4726ES

This study has four specific objectives: 1. Evaluate the effects of a discounted, group visits window on ODH health centers, including how many ultrapoor patients visit the clinic during the discounted, group visits window. 2. Compare the discounted window to an all-day discount to understand whether a time-limited discount is (relatively) more effective at screening in the UP. 3. Document the extent to which the discounted window cannibalizes revenue by shifting patients from other times of day to the discounted window. 4. Analyze whether discounts encourage earlier treatment for mild/moderate malaria, and correspondingly reduce visits for severe malaria.
USA 2026-01-27 19:41:22 2029-01-27 25000 The total set of districts includes ADJUMANI, AGAGO, ALEBTONG, AMOLATAR, AMURIA, AMURU, APAC, DOKOLO, GULU, KADERAMAIDO, KAGADI, KAKUMIRO, KASSANDA, KATAKWI, KIBAALE, KIKUUBE, KITGUM, KOLE, KUMI, KWANIA, LIRA, MASINDI, MUBENDE, NWOYA, OMORO, OTUKE, OYAM, PADER and SERERE. The study sample focuses on villages in the catchment areas of existing ODH health clinics. We include villages that are not health clinic locations, from which more than a minimum number of patients visit ODH health clinics in an average week. We expect to sample roughly six villages per health clinic. All patients from a participating village who visit an ODH clinic included in the study will be considered part of the study. Weiss Fund for Research in Development Economics, Princeton University’s Research Program in Development Economics and OneDay Health Social Science and Humanities Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
 Long-Acting Treatment in Adolescents (LATA); A randomized open-label 2-arm 96-week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa version 1.0 dated 01 December 2021.
REFNo: HS2515ES

• To evaluate an innovative and contemporary ART strategy in HIV- positive adolescents to provide choice for young people facing life-long treatment.
• To evaluate the virological efficacy, safety, acceptability, and quality-of-life of the dual long-acting injectable combination, cabotegravir and rilpivirine, antiretroviral therapy compared to continuous daily oral therapy with triple oral ART consisting of DTG with a backbone of tenofovir either as the TAF or TDF formulations, combined with either 3TC or FTC regimen, to optimize treatment for HIV-positive adolescents in sub-Saharan Africa.

 Kampala, Mulago
 Uganda 2026-01-27 19:28:37 2029-01-27 170 Adolescents aged 12 to 19 years of age living with HIV-1 who are not pregnant or breastfeeding, and are virologically-suppressed (HIV-1 RNA <50 copies/mL) for at least one year, without any known history of treatment failure, on a 3-drug combination ART consisting of an anchor drug with a 2-drug nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone. There will be no exceptions to eligibility requirements at the time of randomisation. Questions about eligibility criteria should be addressed prior to attempting to randomise the participant. The eligibility criteria are the standards used to ensure that only medically appropriate patients are considered for this study. Patients not meeting the criteria should not join the study. For the safety of the patients, as well as to ensure that the results of this study can be useful for making treatment decisions regarding other patients with similar diseases, it is important that no exceptions be made to these criteria for admission to the trial. Participants will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria as defined below. INCLUSION CRITERIA 1. HIV-1-positive 2. Aged 12-19 years 3. Aware of HIV status 4. Body weight ≥35Kg 5. On ART consisting of 2NRTI and a third agent 6. On ART for ≥1 year with no previous regimen change for treatment failure* 7. Virologically suppressed with all HIV-1 RNA viral loads <50copies/mL¥ in the last 12 months up to and including screening. Additionally, there must be one result <50copies/mL¥ at least 12 months prior to screening and the viral load at trial screening must be <50 copies/mL 8. Written informed consent provided by participant (if aged 18 to 19 years) and/or carer/legal guardian (if participant aged 12 to 17 years) as appropriate 9. Written informed assent in participants aged 12 to 17 years 10. Females who are sexually active must be willing to adhere to highly effective methods of contraception⌂ EXCLUSION CRITERIA 1. Known HIV-2 positive 2. Females who are pregnant or breastfeeding 3. Females who plan to become pregnant during the trial follow-up or are sexually active and are unwilling to avoid pregnancy for the duration of the trial 4. Moderate or high-risk score on the Columbia-Suicide Severity Rating Scale 5. Hepatitis B SAg positive 6. ALT ≥3 x upper limit of normal 7. On treatment for active TB 8. Known contraindication to receipt of dolutegravir, cabotegravir, rilpivirine, emtricitabine/ lamivudine and any formulation of tenofovir 9. Participants determined by the investigator to have a high risk of seizure, including those with unstable or poorly controlled seizure disorder 10. Unwilling or contraindication to receiving injections 11. Contraindication to receiving injectable agents in the buttock area 12. Underlying medical condition (e.g. bleeding disorder; use of warfarin) that in the opinion of the investigator precludes participation 13. Previous randomisation in the BREATHER Plus trial University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership Medical and Health Sciences Clinical Trial Non-degree Award
Victoria Nankabirwa
ID: UNCST-2021-R011871
 Relaxation Intervention to Improve Newborn Growth and Maternal Well-being
REFNo: HS6916ES

To examine the effect of the APRB on maternal outcomes such as stress, anxiety and depression.,To evaluate the effect of the adapted APRB on infant outcomes such as growth, feeding and adverse events.,To develop and adapt an audiorecording promoting relaxation during breastfeeding (APRB) for use among postpartum mothers Uganda.,
 Uganda 2026-01-19 15:24:38 2029-01-19 136 Adult women (18 years and above) and their infants.All sexes and tribes are eligible US National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
JOSELYN RWEBEMBERA
ID: UNCST-2021-R013915
 A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop
REFNo: HS6744ES

To explore if risk of progression differs between children who initially received 2 years of oral SAP as compared to 2 years of intramuscular SAP during the GOALIE trial. ,To determine in children with previously diagnosed mild RHD and echocardiographic stabilization after receiving SAP for at least 2 years, if stopping secondary antibiotic prophylaxis (SAP) is non-inferior to continuing SAP in preventing progression over the next 2 years. ,To determine in children with previously diagnosed mild RHD and echocardiographic normalization after receiving SAP for at least 2 years, if stopping SAP is non-inferior to continuing SAP for preventing progression over the next 2 years. ,To determine in children with previously diagnosed mild RHD and echocardiographic normalization or echocardiographic stability after receiving SAP for at least 2 years, if stopping SAP is non-inferior to continuing SAP for preventing progression by 4 years (2 years after SAP discontinuation). ,
 Uganda 2025-12-18 18:47:07 2028-12-18 992 Children and adolescents will be eligible for study participation if they (1) participated in the GOALIE Trial, (2) are found to have echocardiographic normalization or stable mild RHD at study completion, (3) are between the ages of 5-20 years at the time of enrollment. Thrasher Research Fund & Open Philanthropy Medical and Health Sciences Clinical Trial Non-degree Award
Pauline Byakika-Kibwika
ID: UNCST-2019-R001206
 A phase III, multi-country, randomized, placebo-controlled, double-blinded adaptive platform trial to assess the efficacy and safety of treatments for participants with Mpox virus disease
REFNo: HS6913ES

To evaluate the safety and efficacy, as assessed by mortality, hospitalization, complications, duration of symptoms of IP + SOC compared to placebo + SOC in participants with Mpox.,The primary objective is to evaluate the clinical efficacy, as assessed by time to lesion(s) resolution, of IP + Standard of Care (SOC) compared to placebo + SOC for participants with Mpox.,
 Wakiso, kisubi
Mbarara, Mbarara
 Uganda 2025-12-18 18:34:19 2028-12-18 422 Participants fulfilling all the following inclusion criteria are eligible for the study: 1. Signed informed consent or assent for minor participants 2. Adults with positive mpox virus PCR confirmed within 7 days of D1and at least one skin lesion: - with known self-reported HIV positive with or without mucosal lesions - Or - Self-reported HIV negative or unknown HIV status with mucosal lesions 3. Children with positive mpox virus PCR confirmed within 7 days of D1 and at least one skin lesion 4. Newborns with positive mpox virus PCR confirmed within 7 days of D1 and at least one skin lesion 5. Specific to the BCV arm and matching placebo-Women participants of childbearing potential willing to use condoms during treatment and for at least 2 months after the last dose of BCV. 6. Specific to the BCV arm and matching placebo-Male participants with partners of childbearing potential willing to use condoms during treatment and for at least 4 months after the last dose of BCV. i. To protect women of a potential teratogenic treatment ii. and anyhow for MSM (men who have sex with men to avoid sexual transmission PANdemic Preparedness Platform for Health and Emerging Infections’ Response (PANTHER) Medical and Health Sciences Clinical Trial Non-degree Award
Nelson Sewankambo K
ID: UNCST-2020-R014578
 Evaluation of an Information Management and Communication System for Population-wide Point-of-Care Infant Sickle Cell Disease Screening (SIMCS)- A Cluster Randomized Trial
REFNo: HS6567ES

(ii) To evaluate the impact of the SCD SIMCS on access to screening and care and outcomes of children with SCD,
 Jinja, Kakindu
Iganga,
Mayuge,
Kayunga,
Uganda 2025-12-05 18:30:02 2028-12-05 60 Health centers Infants aged 4-6 months National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 Safety, preliminary efficacy, and Pharmacokinetics of Herbal/Natural/ Traditional therapeutic products for the management of Diabetes Mellitus in Uganda.
REFNo: HS6530ES

Main Objective
1. To evaluate the safety, effectiveness and pharmacokinetics of 3 selected NDA- notified herbal/natural/traditional therapeutic products in Uganda, designated IMP1, IMP2, and IMP3.
2. To explore the experiences of innovators, researchers, implementers, and participants involved in this study on the innovation and scientific evaluation of natural therapeutics in Uganda.

Specific Objectives
1. To determine the efficacy of selected NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the treatment of diabetes mellitus in adult patients in Uganda
2. 2. To assess the effect of the selected NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) on specific cardio-metabolic characteristics of adult patients with DM in Uganda.
3. To assess clinical and laboratory adverse events associated with selected NDA- notified herbal/natural/traditional therapeutic products, specifically IMP1, IMP2 and IMP3 in adult patients with DM in Uganda.
4. To investigate the pharmacokinetic profile(s) of NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the management of DM.
5. To explore the experiences of innovators, researchers, implementers, and participants involved in this study on the innovation and scientific evaluation of herbal/natural/traditional therapeutics in Uganda.e the pharmacokinetic profile(s) of NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the management of DM.

Uganda 2025-12-01 14:19:22 2028-12-01 424 Objective 1- 4 Persons with a new or known diagnosis of diabetes mellitus Objective 5 Personnel working in research programs, including: Investigators, Program managers, Clinical staff Innovators of herbal/natural/ traditional therapeutic products purposed for diabetes mellitus management. Objective 1-4 Adult (≥18 years) patients with recently diagnosed diabetes mellitus (diagnosis made in the preceding three months) Objective 5 Individuals who have worked with the CONAT program as investigators, program manager, or clinical staff for at least six months. Innovators of herbal/natural/ traditional products for diabetes mellitus whose product will be found during the survey. Government of Uganda-STI-OP Medical and Health Sciences Clinical Trial Non-degree Award
Sarah Wilker
ID: UNCST-2025-R019791
 One size fits all? Towards individual prediction of treatment success for posttraumatic stress disorder in post-conflict settings (TRAUMA-FIT)
REFNo: HS6712ES

Main Objective 1. to identify individual predictors of treatment response to two different treatments in survivors with PTSD in a post-conflict setting Specific Objectives 1. Investigate whether NET is, on average, more effective than PM+ for the treatment of PTSD 2. Identify predictors of optimal response in the two conditions, and thereby identify predictors of treatment success in a trauma-focused versus present-focused treatment 3. Investigate the explanatory role of socio-ecological factors in PTSD treatment response
 Gulu,
Germany 2025-11-26 14:28:24 2028-11-26 660 (1) Adults of Age between 18 and 65; men and women, Acholi tribe (2) Survivor of trauma related to the LRA conflict or ongoing violence in the post-conflict setting; and (3) Probable diagnosis of PTSD according to DSM-5 (PSSI-5). German Research Foundation Medical and Health Sciences Clinical Trial Degree Award
MALLON TUSUUBIRA
ID: UNCST-2025-R021850
 SURVEY ON PARATUBERCULOSIS IN SLAUGHTERED GOATS AT KAMPALA CITY ABATTIOR
REFNo: A654ES

General objective
To establish the prevalence of Mycobacterium avium subsp. paratuberculosis infection in goats
Specific Objectives
i. To determine the prevalence of the gross and microscopic lesions associated with paratuberculosis in the ileocecal junction and associated lymph nodes of goats slaughtered at Kampala city abattoir
ii. To establish the prevalence of Mycobacterium avium sub species paratuberculosis in suspected cases using polymerase chain reaction (PCR)

 Wakiso, Kampala
 Uganda 2025-11-21 14:36:09 2028-11-21 The sample size required will be calculated by using the formula of the estimation of prevalence in a population (Thrusfield et al., 2018). n = Z².p.(1-p)/d² Where: • n = sample size required • Z = Z-value (1.96 at a 95% confidence interval) • p = expected prevalence (According to standard epidemiologic practices 50% will be used since the prevalence is unknown). (Thrusfield, 2018; Dohoo et al,2009) • d = precision (5%) n = 1.96².0.5. (1-0.5)/0.05² = 384 The samples will be obtained from Kampala city Abattoir, a large goat slaughter house along the old Port Bell Road. The samples will be analysed in the histopathology research laboratory (CDL) and the pathology Laboratory, SVAR Makerere University. The study population will be goats that are brought to the abattoir for slaughter. The goats are from different parts of Uganda, with the majority coming from central and western Uganda. They will be offering a representative population to study the prevalence and incidence of paratuberculosis. The target population will be all the slaughtered goats at the abattoir during the study period. Self sponsored Agricultural Sciences Clinical Trial Degree Award
Martin Origa Jobson Ariel
ID: UNCST-2022-R010809
 Validation of cervical cancer screening methods in Uganda: The National Cancer Management and Capacity building Project in Uganda (CANCAP UG) experience.
REFNo: HS6635ES

To assess multiple screening methods: VIA, PAP smear, HPV, and colposcopy, plus or minus biopsy.,To evaluate the indicators of screening accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of Visual Inspection with Acetic acid (VIA) test by comparing with the gold standard of disease status confirmed via histological results.,
 Mbarara, cities
Mbarara, cities
Kampala, mulago
Kampala, kisenyi
 Uganda 2025-11-21 14:33:45 2028-11-21 4000 All women, 25 years old meeting the inclusion criteria and attending the screening clinic at CANCAP sites uganda cancer insitute Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Mukonzo
ID: UNCST-2021-R013916
 Safety of COVIDEX™ Therapy in adults: in Uganda: A randomized controlled open- label phase 1 clinical trial.
REFNo: HS6540ES

Overall aim
To validate the safety of COVIDEX™ therapy in adult Ugandans.

Specific objectives
Primary objective
To evaluate and document adverse events associated with COVIDEX™ among adults
in Uganda.

Secondary objective:
To determine the plasma concentration of berberine in adults receiving COVIDEX™ at
three different dose levels.
Kampala,
Uganda 2025-11-21 14:11:01 2028-11-21 72 Study participants shall be healthy adult volunteers of 18years and above JENA HERBALS LIMITED Medical and Health Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women
REFNo: HS6565ES

To evaluate the efficacy of MK-8527 qm compared to FTC/TDF qd for the prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections To evaluate the safety and tolerability of MK-8527 qm compared to FTC/TDF qd.
 Masaka, Masaka
 Uganda 2025-11-21 11:18:30 2028-11-21 150 This study includes participants of varying age, race, ethnicity, and sex, female at birth, Aged from 16 years to 30 years of age inclusive, at the time of providing the informed consent or assent and Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during screening. Merck Sharp & Dohme LLC Medical and Health Sciences Clinical Trial Non-degree Award
ERIC WOBUDEYA
ID: UNCST-2019-R001047
 Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined with Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age with and without HIV
REFNo: HS6555ES

Primary Objectives
Cohort 1 and Cohort 2
• To determine the weight-band dosing of RPT taken as part of the 1HP regimen by evaluating:
⎯ PK RPT exposures among children with and without HIV
⎯ Safety and tolerability of the 1HP regimen among children with HIV while receiving twice-daily DTG and children without HIV through 28 days of dosing
Cohort 2
• To evaluate the effect of RPT taken as part of the 1HP regimen on the PK of DTG
Secondary Objectives
Cohort 1 and Cohort 2
• To evaluate the effect of covariates including age, weight, sex, ethnicity, nutritional status, and HIV-1 status on the PK of RPT taken as part of the 1HP regimen
• To evaluate the safety of the 1HP regimen through 24 weeks of follow-up
• To evaluate the palatability and acceptability of the 1HP regimen
• To evaluate adherence to the 1HP regimen
Cohort 2
• To evaluate the safety and tolerability of twice-daily DTG through 42 days among children with HIV who are receiving 1HP
• To evaluate virologic control (less than 200 copies/mL) at Day 42 among children taking a DTG-based ARV treatment regimen co-administered with 1HP

Kampala, mulago
 Uganda 2025-11-04 12:59:17 2028-11-04 40 children living without HIV (Cohort 1) and children living with HIV (Cohort 2) at risk of TB disease who are less than 13 years of age. National Institute of Allergy and Infectious Diseases Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute of Mental Health Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 A5402 An Open-Label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV
REFNo: HS6604ES

1.2 Primary Objectives

1.2.1 To compare pramipexole to escitalopram in the treatment of MDD (and comorbid MDD with MND) based on the Beck Depression Inventory-II (BDI-II/BDI-2) total score [Beck 1996] from baseline to week 24.

1.2.2 To evaluate the safety of pramipexole and escitalopram in PWH having MDD (and comorbid MDD with MND) from baseline to week 24.

1.3 Secondary Objectives

1.3.1 To compare pramipexole to escitalopram in the treatment of MDD using MDD caseness, neurocognitive outcomes, and functional status from baseline to week 24.

1.3.2 To compare the depression, neurocognitive, and functional status outcomes in PWH with MDD alone and with comorbid MDD with MND treated with pramipexole versus escitalopram from baseline to week 24.

1.3.3 To compare the impact of pramipexole and escitalopram on all outcomes above by female versus male sex (assigned at birth) from baseline to week 24.

1.3.4 To determine the impact of pramipexole compared to escitalopram on the measure of HIV-1 RNA viral load in the peripheral blood.

1.4 Exploratory Objectives

1.4.1 To characterize associations between escitalopram trough concentrations and treatment efficacy (BDI-II/BDI-2 total score) as well as participant adverse events (adverse event frequency, severity, and discontinuation rates).

1.4.2 To characterize associations between escitalopram trough concentrations and genetic polymorphisms that affect metabolizing enzymes of escitalopram (known metabolizing enzymes include CYP2C19, CYP2D6, and CYP3A4).

1.4.3 To explore associations between cerebrospinal fluid (CSF) concentrations of escitalopram and BDI-II/BDI-2 total score.

1.4.4 To evaluate adverse events potentially related to drug interactions between antiretroviral therapy (ART) and escitalopram and pramipexole, respectively.

1.5 Substudy Objective

1.5.1 CSF Substudy

To compare the impact of pramipexole and escitalopram on biomarker outcomes in a CSF substudy of participants with MDD alone.

 Uganda 2025-10-29 16:04:25 2028-10-29 50 PWH having a diagnosis of MDD alone or with comorbid MDD and MND · ≥18 to ≤70 years old both male and female. People who understand English and Luganda because the site informed consent forms only in Luganda and English National Institute of Allergy and Infectious Diseases and CIPLA Medical and Health Sciences Clinical Trial Non-degree Award
Abel  Kakuru
ID: UNCST-2022-R009193
 Dihydroartemisinin-piperaquine plus sulfadoxine-pyrimethamine versus sulfadoxine-pyrimethamine alone for the prevention of febrile illnesses in children with sickle cell anemia: a double-blind randomized controlled trial
REFNo: HS6294ES

1.
To compare the incidence of all-cause febrile illness among children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
2.
To compare the incidence of adverse events among children with sickle cell anemia randomised to receive monthly SP vs. monthly DP+SP.
3.
To compare the prevalence of markers of antimalarial resistance, including those associated with SP and DP resistance, among parasitemic children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
 Busia, Selected parishes
 Uganda 2025-10-29 15:55:44 2028-10-29 232 children with sickle cell anemia Aged 2-10 years children with sickle cell anemia Thrasher Research Fund Medical and Health Sciences Clinical Trial Non-degree Award
Kyambadde Ronald
ID: UNCST-2025-R016678
 HIGH DOSE VS STANDARD DOSE CAFFEINE THERAPY FOR APNEA OF PREMATURITY: A RANDOMISED CONTROL TRIAL.
REFNo: HS5776ES

To compare the efficacy and safety of high-dose caffeine citrate (loading dose 40 mg/kg/day, and maintenance of 20mg/kg/day), versus standard dose (loading dose of 20 mg/kg/day, maintenance of 10mg/kg/day), in preventing the occurrence and reducing the frequency of apneas among preterm infants ≤ 34 weeks’ gestation with Apnea Of Prematurity in the first 7 days of life.


Specific Objectives

1. To determine the effect of high dose compared to standard dose of caffeine on the incidence of apnea of prematurity among preterm babies at St. Francis Hospital, Nsambya, and Uganda
Martyrs’ Hospital Lubaga.

2. To determine the side effects of high dose compared to standard dose caffeine in preterm infants.
 Kampala, Nsambya
Kampala, Lubaga
 Uganda 2025-10-21 9:08:50 2028-10-21 122 participants preterm babies born at the study sites during the study period with a New Ballard score ≤ 34 weeks no sponsorship Medical and Health Sciences Clinical Trial Degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women
REFNo: HS6666ES

To evaluate the efficacy of MK-8527 qm
compared to FTC/TDF qd for the
prevention of HIV-1 infection as assessed
by the incidence rate per year of adjudicated
HIV-1 infections.
Hypothesis: MK-8527 qm is superior to
FTC/TDF qd with respect to the hazard
ratio for HIV-1 infecti
 Mityana,
Kalangala,
Kampala,
Masaka,
Wakiso,
Uganda 2025-10-16 17:51:09 2028-10-16 Approximately 4580 participants 16 to 30 years of age Merck Sharp & Dohme LLC Medical and Health Sciences Clinical Trial Non-degree Award
Helen Byakwaga
ID: UNCST-2019-R001168
 A Phase III/IV factorial randomised double-blind trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin/ezetimibe versus pitavastatin, in patients with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk (Optimising metabolic management on integrase-based antiretroviral therapy – the OPTIMAR Study)
REFNo: HS5819ES

To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on: fasting lipids, cardiovascular disease risk assessment measures; inflammatory biomarkers; and safety and tolerability,To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on: intermediate markers of cardiovascular disease risk; cardiovascular disease risk assessment measures; clinical consequences of increased body weight; and safety and tolerability of dapagliflozin,To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on LDL concentration change from baseline to week 24,To assess the impact of dapagliflozin vs. placebo on absolute weight change from baseline to week 24,The overall objective of the study is to examine the impact of dapagliflozin vs. placebo on metabolic parameters in PWH with high metabolic risk who are on INSTI-based ART.,
 Kampala, Mulago I
 Uganda 2025-09-30 14:11:23 2028-09-30 30 at the Infectious Diseases Institute Kampala All adults aged 40-75 years, both female, all tribes will be included. The Kirby Institute Medical and Health Sciences Clinical Trial Non-degree Award
Joweria Nambooze
ID: UNCST-2019-R001118
 Effect of consumption of cape gooseberries on blood glucose control among patients with type 2 diabetes mellitus in Kampala, Uganda
REFNo: HS6017ES

To evaluate patient adherence to dietary interventions involving gooseberries,To compare change in glycated hemoglobin (HbA1c) levels among T2DM patients consuming gooseberries regularly as part of their diet with those following a regular diet. ,To assess the effect of regular consumption of gooseberries on fasting blood glucose levels in T2DM patients.,To evaluate the effect of cape gooseberries on blood glucose control among patients with T2DM in Kampala, Uganda.,
 Kampala, All parishes
 Uganda 2025-09-26 18:13:11 2028-09-26 200 The study will include adult patients with T2DM who attend the Saint (St) Francis Nsambya hospital diabetes clinic and the Mulago hospital diabetes clinic in Kampala. Convenience sampling will be used to select patients from these clinics who meet specific study criteria and are readily accessible. The two study sites will be purposively selected due to having established T2DM clinics, high patient volume, diverse population and proper patient records. However, the study participants will be randomly allocated to the study arms. Kyambogo University Medical and Health Sciences Clinical Trial Non-degree Award
Patrick Okema
ID: UNCST-2025-R019099
 Insulin storage in low resource settings, impact on the glycated hemoglobin.
REFNo: HS6078ES

To determine the modalities of insulin storage in children and adolescents with T1D in low resource settings and the effects on their Hemoglobin A1C (HbA1C) in northern Uganda
 Gulu, All parish
Amuru, All parish
Nwoya, All parish
Omoro, All parish
 Uganda 2025-09-26 18:07:55 2028-09-26 60 - 100 Children and young adolescent with Type1 diabetes registered and is receiving care at the Gulu Regional Referral Hospital under the age of 23 years Sonia Nabeta Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Jef VanPuyenbroeck
ID: UNCST-2025-R017911
 Monitoring anthelmintic resistance in goats in Nwoya District, Uganda
REFNo: A617ES

Main objective:
To assess the efficacy of anthelmintics commonly used by goat farmers in Nwoya district.
Specific Objectives:
1. To determine the prevalence of GIN infesting goats in Nwoya district.
2. To determine nematode species infesting goats in Nwoya district, through coproculture and molecular speciation.
3. To compare the expenses to perform routine FECRT, with McMaster and Mini-FLOTAC, for monitoring anthelmintic resistance in Uganda.
4. To assess the efficiency of survey designs and fecal egg count methods to determine drug efficacy at a certain cost and endemicity.
 Nwoya, All
Nwoya, All
Nwoya, All
 Belgium 2025-09-26 18:06:25 2028-09-26 383 All goat herds, kept for livelihood purposes, in Nwoya District will be considered to be included in this study. Ghent University Agricultural Sciences Clinical Trial Degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 An open-label, randomised, controlled, non-inferiority trial to compare the efficacy, safety and tolerability of a fixed dose Triple Artemisinin-based Combination Therapy (TACT) artemether-lumefantrine-amodiaquine versus first-line Artemisinin-based Combination Therapies (ACTs) for the treatment of uncomplicated Plasmodium falciparum malaria
REFNo: HS6344ES

To compare the efficacy of ALAQ vs AL and ALAQ vs ASAQ as defined by the 28-day PCR corrected adequate clinical and parasitological response (ACPR).
 Tororo, Selected parishes
Busia, Selected parishes
 Uganda 2025-09-26 17:41:17 2028-09-26 1680 Male or female Participants with acute uncomplicated P. falciparum malaria University of Oxford Medical and Health Sciences Clinical Trial Non-degree Award
Robert Ssekitoleko
ID: UNCST-2019-R001716
 A Feasibility and Safety Study of the KeySuite Laparoscopic Devices for Cancer Diagnosis in Uganda
REFNo: SIR493ES

1. To evaluate potential safety issues associated with the use of the KeyScope in patients with intra-abdominal cancers or suspected cancers .
2. To determine the clinical performance of the KeyScope in viewing tissue masses in the abdomen.
3. To determine the clinical performance of the KeyLoop in retraction of the abdominal wall during laparoscopic surgery
4. To determine the acceptability of KeySuite laparoscopic devices in aiding to obtain laparoscopic biopsies

Kampala, Mulago II
 Uganda 2025-09-26 17:12:49 2028-09-26 12 The study is targeting 12 adult patients with cancer advised for an intra-abdominal biopsy to be collected for confirmatory. The study will target patients aged between 18 and 60 years. National Institute of Health Engineering and Technology Clinical Trial Non-degree Award
Catriona  Waitt John
ID: UNCST-2019-R001068
 Drug Optimisation for LMICs in Pregnant HIV mothers and their INfants: temporary switch to CAB/RPV long acting injections in postpartum period
REFNo: HS5982ES

To characterise drug exposure in breast milk, and drug transfer to infants through breastfeeding, as well as infant drug elimination. To characterise the elimination of CAB/RPV by describing PK profiles of IM CAB/RPV LA after last injection between 48 and 96 weeks. To establish strategies on how to safely re-establish oral ART after discontinuation of IM CAB/RPV LA at 48 weeks and switch back to daily oral ART. To explore early postpartum PK of CAB/RPV in maternal plasma and breastmilk. To demonstrate antiviral activity and impact on retention in HIV care of temporarily switching to CAB/RPV LA compared with continuation of daily oral ART over 48 weeks.,
 Kampala, Kampala
 UK 2025-09-17 13:21:16 2028-09-17 309 Consenting pregnant women living with HIV University of CapeTown Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Bisegerwa
ID: UNCST-2022-R011022
 Accuracy of Pulse Oximeters with Profound Hypoxia
REFNo: HS6506ES

To generate two to three evidence-based recommendations to regulatory and procurement bodies within six months of study completion to guide pulse oximeter selection for diverse populations.,To collect and contribute data on pulse oximeter accuracy across diverse skin tones to an open-access device performance database by the study’s end, enabling manufacturers to refine pulse oximeter technology and ensure equitable performance across all skin tones, especially in low-resource settings.,To replicate the UCSF Hypoxia Lab in Uganda by establishing a fully equipped and operational facility within a year to evaluate pulse oximeter accuracy across diverse skin tones and hypoxia levels.,To evaluate the accuracy of pulse oximeters under controlled hypoxic conditions in a diverse population in Uganda, with a focus on understanding and addressing disparities in device performance related to skin pigmentation.,
 Kampala, Kololo
 Uganda 2025-09-12 17:03:12 2028-09-12 432 This study will be done on healthy male or female participants between the ages of 18-50 years. Association of Anesthesiologists of Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Pauline Amuge Mary
ID: UNCST-2023-R005532
 LC-REVITALIZE – A Long Covid Repurposed Drug Study
REFNo: HS6370ES

-To assess the efficacy of repurposed drugs compared to their
respective placebos in reducing standardized symptom severity scores
in participants with Long Covid.
-To compare the symptom burden (e.g., anxiety, depression, overall
well-being) in participants with Long Covid treated with repurposed
drugs versus their respective placebos.
- To assess whether symptom burden worsens in participants with Long
Covid treated with study drugs versus placebo, specifically when
symptoms are reported across multiple scales.
- To assess changes in exercise capacity over time of participants with
Long Covid treated with study drugs versus their respective placebos.
- To measure specific Long Covid pathophysiological biomarkers of study
drugs versus their respective placebos.

 Wakiso, Sabagabo
 Uganda 2025-09-12 17:00:13 2028-09-12 384 Adults, male and female with Long COVID Dr. Douglas D. Fraser- Western University Medical and Health Sciences Clinical Trial Non-degree Award
alice namatovu
ID: UNCST-2025-R017415
 EVALUATION OF THE EFFECTIVENESS OF BACTERIOPHAGE COCKTAILS AGAINST MULTI-DRUG-RESISTANT BACTERIA ON PATIENTS WITH DIABETIC FOOT ULCERS ATTENDING SELECTED REFERRAL HOSPITALS IN UGANDA
REFNo: HS5652ES

Main objective:
To assess the efficacy of bacteriophages in the management of diabetic foot wounds/ulcers in animal models and among patients attending the selected referral hospitals in Uganda.

Specific Objectives
i) To determine the biological and genotypic characteristics of lytic bacteriophages against the MDR- bacteria isolated from diabetic wounds of patients.

ii) To determine the virulence genes of the bacteria isolated from DFU patients and those genes associated with antimicrobial resistance.
iii) Determine the phage receptor genes on the MDR bacteria isolated from DFU patients.

iv). To evaluate the effectiveness of the identified Bacteriophage preparation/cocktail in the healing of induced diabetic wounds in mice.
v). To evaluate the effectiveness of the identified bacteriophage preparation/cocktail in the healing of diabetic foot wounds on patients in selected referral hospitals in Uganda.

 Kampala, Namirembe
Kampala, Nsambya
 Uganda 2025-09-12 16:14:57 2028-09-12 138 human participants The study will be conducted on patients attending the selected regional referral hospitals in Uganda diagnosed with diabetes including those having diabetic foot ulcer/wounds that are not responding to antibiotic therapy, those with diabetes and not having diabetic foot and those without diabetes but having chronic wounds. Inclusion and exclusion criteria: All Patients of 18 years and above, male or female diagnosed with diabetes and willing to participate in the study will be included. Diabetic type will be determined clinically based on the diabetes control strategy used. Those depending on insulin for diabetes control since the time of diagnosis will be classified as having T1DM while those who had been controlled on oral anti-diabetic drugs with or without insulin will be categories as T2DM. One hundred and thirty-eight patients expected to participate in the study as cases are expected to have non traumatic DFU while the control group will include diabetic patients without DFU and non-diabetic patients with chronic foot wounds. The different groups will be matched for age and gender. The exclusion criteria will include pregnant women, patients with other diabetes other than types 1 and 2, and those with wounds limited to above the ankle joints. Makerere Research and innovation Fund by the Ugandan Government Medical and Health Sciences Clinical Trial Non-degree Award
Nazarius Tumwesigye Mbona
ID: UNCST-2019-R000664
 WEB-BASED INTERVENTION FOR ALCOHOL AND SUBSTANCE ABUSE AMONG YOUNG UNIVERSITY STUDENTS
REFNo: SS1785ES

To assess feasibility and effectiveness of the web-based intervention for prevention and treatment of ASUD problems among youth 18-24 years attending Universities in Uganda,To develop a web-based intervention for prevention and treatment of ASUD problems among youth 18-24years attending Universities in Uganda,To establish the prevalence of ASUD problems among youth 18-24years in selected Universities,To contribute to the improvement of the quality of ASUD treatment services in Uganda among the youth through the development of a web-based intervention and assess its feasibility and effectiveness for the prevention and treatment of ASUD among University students in Uganda,
 Kampala, Mulago
Mpigi, Nkozi
 Uganda 2025-09-09 8:17:25 2028-09-09 5000 Any student aged 18 – 24 years at any level of education from the following universities: Makerere University, Kyambogo University, Makerere University Business School (semi-independent public entity), Uganda Christian University, Uganda Martyrs University Nkozi, Kampala International University (KIU) and Ndejje University. Government of Uganda Social Science and Humanities Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 Randomised controlled trial to assess the efficacy of artemisinin combination therapies in a setting of emerging artemisinin resistance in Uganda.
REFNo: HS6327ES

To assess the 42-day clinical and parasitological efficacy of artemether-lumefantrine (AL) and pyronaridine-artesunate (PA) for the treatment of uncomplicated P. falciparum malaria in Uganda.
 Arua, Selected parishes
Tororo, Selected parishes
 Uganda 2025-09-09 16:41:47 2028-09-09 150 patients on each treatment arm per site, 600 participants in total, (300 per site, AL: 150, PA: 150). Febrile patients aged 6 months to 10 years with confirmed uncomplicated P. falciparum malaria. Infectious Diseases Research Collaboration (IDRC) Medical and Health Sciences Clinical Trial Non-degree Award
Fred  Bulamba
ID: UNCST-2020-R014888
 PErioperative respiratory care and outcomes for patieNts Undergoing hIgh risk abdomiNal surgery
REFNo: HS2178ES

To explore the cost-effectiveness of the different treatment combinations in reducing pneumonia and SSI at pre-selected centres.,To assess the impact of both interventions on postoperative mortality at 30-days, and the effect of 80-100% FiO2 only on the re-operation rate at 30 days after surgery.,To assess whether (1) preoperative 0.2% chlorhexidine mouthwash reduces the rate of postoperative pneumonia at 30-days compared to no mouthwash, and (2) 80-100% FiO2 used during surgery reduces the rate of postoperative SSI at 30-days compared to 21-35% FiO2, amongst patients aged 10 years or over undergoing elective or emergency midline laparotomy, with an anticipated abdominal incision of ≥5cm, for any indication except caesarean section.,
 Mbale, Hospital cell
 Uganda 2025-08-28 10:15:49 2028-08-28 1000 (for Uganda only) Patients above 10 years undergoing abdominal surgery Dr Birgit Whitman Medical and Health Sciences Clinical Trial Non-degree Award
Edwin Nuwagira
ID: UNCST-2021-R013488
 EFFICACY AND TOLERABILITY OF SHORT-COURSE INTERMITTENT INTRAVENOUS LIPOSOMAL AMPHOTERICIN B VERSUS ORAL POSACONAZOLE FOR CHRONIC PULMONARY ASPERGILLOSIS: A PHASE IIA, PROSPECTIVE, MULTI-CENTRE, RANDOMIZED, CONTROLLED, OPEN-LABEL, FEASIBILITY TRIAL
REFNo: HS6400ES

5. Assess recruitment and retention of patients with CPA on a trial to inform design and sample size for a definitive efficacy trial.,4. To assess adherence to posaconazole therapy,3. To evaluate the utility of different trial endpoints (change in Aspergillus IgG antibody titer, radiological improvement, step test and weight) across groups.,2. To compare 12-month all-cause mortality in each arm,1. To measure emergence of isolates of Aspergillus with resistance/reduced susceptibility to posaconazole in both arms. ,1. Compare the efficacy and tolerability of 1) short course, high dose of intravenous liposomal amphotericin B, 2) short course, high dose of intravenous liposomal amphotericin B followed by daily posaconazole, or 3) posaconazole alone for the treatment of CPA for 6 months.,
 Mbarara, Medical cell
Gulu, Medical cell
Kampala, Salama road
 Uganda 2025-08-26 13:48:03 2028-08-26 120 Adults, age > or = to 18 years All Ugandan tribes living in Ankole/Kigezi sub region Both women and men Fungal Infection Trust Medical and Health Sciences Clinical Trial Non-degree Award
RACHEL LUWAGA
ID: UNCST-2024-R003040
 EFFECT OF A DISCHARGE EDUCATION INTERVENTION ON PREVENTION OF PUERPERAL SEPSIS AMONG MOTHERS WHO HAVE DELIVERED BY CESAREAN SECTION IN SOUTHWESTERN UGANDA
REFNo: HS5504ES

. To determine the prevalence, factors, and outcomes associated with readmission of
mothers who had undergone cesarean section delivery due to sepsis in Mbarara Regional
Referral Hospital
2. To describe the experiences and practices of mothers in the prevention of puerperal sepsis
post cesarean section in Mbarara Regional Referral Hospital
3. To explore the barriers and facilitators to the provision of discharge instructions
regarding puerperal sepsis prevention for mothers who have delivered by cesarean
section in Mbarara Regional Referral Hospital
4. To determine the effect of a discharge education intervention in the prevention of puerperal of
sepsis in post-cesarean section mothers.

Mbarara, Kamukuzi
 Uganda 2025-08-18 13:28:40 2028-08-18 8-10 mother with peurperal sepsis,8-10 health workers, 130 pr mothers diagnosed with puerperal sepsis after cesarean section delivery Health workers working on the obstetric and gynecology ward Primipara mothers who have delivered by cesarean section self sponsorship Medical and Health Sciences Clinical Trial Degree Award
Claire Nimusiima
ID: UNCST-2025-R017994
 Assessing the association Between Disability and Mental Health among older adults: A Secondary Data Analysis of the Health and Wellbeing of Older People - Wave 5 study in Uganda.
REFNo: HS6244ES

Primary Objective
To assess the association between disability and mental health outcomes among older adults in Uganda.

Secondary Objectives
- To determine the prevalence of mental health disorders among older adults with and without disabilities.
- To explore whether any socio-demographic factors modify the association between disability and mental health outcomes.
- To assess whether HIV status confounds the association between disability and mental health outcomes.

 Not Applicable (N/A), Not Applicable
 Uganda 2025-08-08 13:49:11 2028-08-08 588 The WOPS V study population consists of older adults (aged 50 years and above), including both HIV-positive individuals on ART and HIV-negative individuals. In Wave 5, 588 participants were surveyed. The WOPS study was conducted in 3 districts in Uganda: Masaka, Kalungu, and Wakiso. Participants are recruited from rural, peri-urban, and urban settings, including community health centers and HIV care clinics. The study was coordinated by the MRC/UVRI & LSHTM Uganda Research Unit. It is this study population that shall be included in the "Assessing the association Between Disability and Mental Health among older adults: A Secondary Data Analysis of the Health and Wellbeing of Older People - Wave 5 study in Uganda" study No funding is available for this proposed research as this is going to use already existing dataset. However, the WOPSV study was sponsored by National Institutes of Ageing, USA, through World Health Organization Study on Global Ageing and Adult Health (SAGE) Medical and Health Sciences Clinical Trial Degree Award
David Meya Bisagaya
ID: UNCST-2019-R000837
 A Phase 2 Novel Antimicrobial Combination Therapy to Treat Tuberculous Meningitis
REFNo: HS5711ES

1. Assess the safety and efficacy of a novel anti-TB combination regimen with greater bactericidal activity than current standard of care (SOC) therapy
 Kampala, all parishes
Mbarara, all parishes
 Uganda 2025-07-18 14:05:06 2028-07-18 150 All adults with TBM meningitis (definite, probable) with HIV, per the uniform TBM case definition. Meningitis Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Felix Magala
ID: UNCST-2024-R016043
 Incidence of Post-Operative Sore Throat Among Patients Undergoing Open Abdominal Surgery: A Randomized Control Trial Comparing Video and Direct Laryngoscopy
REFNo: HS5685ES

To compare the incidence of POST, and recovery from POST following intubation using Video laryngoscopy or Direct laryngoscopy during general anaesthesia among general surgery patients undergoing laparotomy at MRRH
1. To determine the incidence of POST in the first 24 hours following intubation with either Video-laryngoscopy or Direct-laryngoscopy for patients undergoing open abdominal surgery at MRRH
2. To determine the recovery time from POST among patients intubated with Video laryngoscopy compared to Direct-laryngoscopy.
3. To describe the symptoms associated with POST amongst patients intubated for open abdominal surgery
 Mbarara, Mbarara
 Uganda 2025-07-11 18:00:56 2028-07-11 148 Study population We will recruit surgical patients scheduled for laparotomy (open abdominal surgery, requiring an incision of at least 5cm) at the surgical and emergency ward of MRRH. Eligibility criteria We shall include; • General surgery patients scheduled for laparotomy under general anaesthesia. • Aged 18 years and above. • ASA class I to III. • Mallampati class I to II. We shall exclude: • Have had an upper respiratory tract infection or have had an endoscopy or bronchoscopy procedure in the past 2 weeks. • Have had any ENT, neck or thoracic surgery in past 3 months. • Those who have symptoms of gastroesophageal reflux disease (GERD). • And those with history of smoking. • Those with anatomical abnormality in the neck, head, face. • Edentulous patient. • Patients with suspected difficult airway as assessed by the principal investigator. self sponsored Medical and Health Sciences Clinical Trial Degree Award
Daniel Atwine
ID: UNCST-2019-R012948
 SAFETY AND EFFICACY OF THE PHOTO-KABADA DEVICE AS COMPARED TO DEVICES IN ROUTINE USE IN ADMINISTERING PHOTOTHERAPY FOR BABIES WITH NEONATAL JAUNDICE: AN OPEN-LABEL, RANDOMIZED CONTROLLED CLINICAL TRIAL (MUST-2024-1404).
REFNo: HS5411ES

5) Secondary: To describe the experiences of health workers using the test (Photo-Kabada) and control PT devices and caretakers of children treated with these devices.,4) Secondary: To compare the other safety and efficacy outcomes when babies are treated with Photo-Kabada compared to available phototherapy devices on the neonatal unit of MRRH. ,3) Secondary: To compare the reduction in bilirubin levels per unit time when babies are treated with Photo-Kabada compared to available phototherapy devices on the neonatal unit of MRRH. ,2) Primary: To compare the efficacy of Photo-Kabada phototherapy machine with existing phototherapy machine at selected hospitals in treating neonates with jaundice.,1) Primary: To compare the safety of Photo-Kabada phototherapy machine with existing phototherapy machine at selected hospitals in treating neonates with jaundice.,
 Mbarara, Nyamitanga
 Uganda 2025-07-10 11:09:52 2028-07-10 30 neonates less than 28 days old. Both male and female. Villgro Africa Medical and Health Sciences Clinical Trial Non-degree Award
Esther Cathlyn  Atukunda
ID: UNCST-2022-R009265
 Evaluating Healthy Families PrEP: an intervention to promote PrEP use during periconception, pregnancy and postpartum periods for women in rural Uganda
REFNo: HS6117ES

1. Adapt Healthy Families-PrEP (HF-PrEP) to community clinics in Mbarara and Sheema Districts, Uganda to include postpartum women guided by our conceptual framework and the Consolidated Framework for Implementation Research (CFIR

2. Test Healthy Families-PrEP intervention effectiveness in a cluster-randomized control trial in Ugandan community health centers (HCs)

3. Determine incremental cost-per-person participating in Healthy Families-PrEP and estimate cost-effectiveness per incident HIV infection averted among women and their infants.
 Mbarara, All parishes
Sheema, All parishes
 Uganda 2025-07-09 16:14:46 2028-07-09 approximately 700 women There will be two groups of participants engaged for these studies: 1) women ages 18-45 years, in periconception, pregnant, and postpartum periods seeking health services from the community health centers 2) healthcare providers, administrators, and Ministry of Health officials National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Laura Nsangi Joan
ID: UNCST-2025-R016715
 ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse
REFNo: HS6040ES

The primary objective is to determine if valganciclovir is safe and efficacious in reducing CMV viraemia amongst hospitalised adults with advanced HIV disease and CMV viraemia.
Secondary objectives are to determine the effect of valganciclovir on mortality, to study its pharmacokinetics and explore the immunological response of patients with CMV viraemia before and after treatment with valganciclovir.

 Kampala, Mulago
 Uganda 2025-07-04 14:08:02 2028-07-04 150 Adults and adolescents (≥ 15 years) diagnosed with advanced HIV disease and CMV viraemia, with a CD4 count ≤ 100 cells/μL and CMV viral load >500 IU/mL. Wits Health Consortium Medical and Health Sciences Clinical Trial Non-degree Award
Sam Ononge
ID: UNCST-2020-R000328
 A CLINICAL TRIAL TO EVALUATE THE PERFORMANCE AND SAFETY OFTHE WEKEBERE SYSTEM FOR MONITORING FETAL WELLBEING DURING LABOUR
REFNo: HS3407ES

The overall objective of this study is to demonstrate safety and performance of wekebere fetal monitoring system.

Specific Objectives
To determine accuracy of wekebere fetal monitoring in comparison with gold standard. To determine the safety of wekebere system
To determine’ uterine contractions

 Kampala, Kawempe
 Uganda 2025-06-30 9:35:11 2028-06-30 120 The study population will consist of the following inclusion criteria: i.Female age between: 18-50 ii.Gestational age >36 + 0 weeks iii.Singleton pregnancy iv.Early labor (cervical dilatation of <6cm) v.Sign informed consent Villgro Africa Medical and Health Sciences Clinical Trial Non-degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
 OPTIMAH Study: OPTImizing Malaria And HIV treatment in a shifting landscape in Africa
REFNo: HS6165ES

PRIMARY OBJECTIVES
1. Assess the impact of HIV/DTG on weight gain (BMI) in Ugandan children ages 5 to 17 years of age over two years of follow-up.
2. Assess for PK drug-drug interactions between the two most widely used ACTs
(AL or AS-AQ) and DTG in longitudinal cohorts of HIV-uninfected children and CLHIV living in a high endemic malaria region (Busia).
3. To assess the 28- and 42-day efficacy of AL and AS-AQ for the treatment of uncomplicated malaria in children with and without HIV in a setting where artemisinin resistance has emerged.

SECONDARY OBJECTIVES
1. To assess the impacts of DTG on changes in body composition, waist circumference, and metabolic derangements over 2-years of longitudinal follow-up.
2. To assess the impact of repeated malaria infection on changes in weight gain in CLHIV on DTG (comparing HIV-infected cohorts in Busia and Kampala).
3. To determine if changes in DTG PK exposure in the presence of repeated courses of ACTs are associated with impacts on virologic control (pharmacodynamics).
4. To assess for the development of dolutegravir-associated resistance mutations over two years of follow-up.
5. To determine if changes in ACT exposure in the presence of daily DTG for HIV treatment are associated with impacts on malaria treatment outcomes.
6. To critically compare the PK exposure of artemether, artesunate, and DHA in the context of the two leading ACTs in Africa and assess for associations between the PK exposure of artemisinin derivatives as drivers of parasitologic outcomes such as parasite clearance rates for artemisinin-sensitive and resistant infections.
7. To assess levels of gametocytemia in children with and without HIV infection and with artemisinin-sensitive and -resistant infections
8. To determine if repeated course of AL and AS-AQ are associated with selection of resistance-associated mutations to the partner drugs and/or the artemisinin component.
9. To identify novel mutations in known and/or putative loci associated with resistance to artemisinins, lumefantrine, and amodiaquine using amplicon-based sequencing and/or other genotyping methods.
10. To assess the exposure of unbound DTG, lumefantrine, and DEAQ and association with clinical outcomes (viral load or parasitemia)



 Busia, All Parishes
Kampala, Mulago
 Uganda 2025-06-26 23:59:42 2028-06-26 380 CLHIV, ages 5-17 years, will be identified from respective registers at Baylor-Uganda (in Kampala) and the Masafu HIV clinic (and nearby clinics) in Busia Uganda. HIV-uninfected children, also ages 5-17 years, will be enrolled from catchment areas at these two sites. Recruitment will be balanced by age and sex. The National Institute of Child Health and Human Development Medical and Health Sciences Clinical Trial Non-degree Award
Jolly  Kamugisha G.K.
ID: UNCST-2023-R005715
 Performance and Factors Affecting the Implementation of the Integrated Management of Acute Malnutrition Programme: A Study of Kampala, Mukono, Wakiso and Kayunga Districts
REFNo: HS6084ES

5. To document the lessons learnt and best practices during implementation of the IMAM program in the four target districts during the calendar year 2022 and 2023.,4. To establish factors that affect the utilization of IMAM services in the four target districts.,3. To determine factors influencing treatment outcomes of children with wasting in the four target districts.,2. To determine the performances of the integrated management of acute malnutrition program in the four target districts during the calendar year 2022 and 2023.,1. To identify the communities contributing to a high burden of childhood wasting caseload in health facilities in four target districts (Kampala, Mukono, Wakiso and Kayunga),The overall objective of this study is to assess the nutrition service delivery and factors influencing utilization of the IMAM programme in Kampala, Mukono, Wakiso and Kayunga districts,
 Kampala,
Mukono,
Wakiso,
Kayunga,
Uganda 2025-06-20 8:41:29 2028-06-20 Sample size varies by objective as follows: Objective 1: 1440 records; Objectives 3-5: 5 key informants ()KIIs) at policy level; 8 KIIs - district and facility administrators; 7 KIIs for health workers at facility level. 1) Children aged < 5years with acute malnutrition - both boys and girls (Records review) 2) Caregivers of children treated acute malnutrition (both females and males aged 18+years) 3) Village Health Teams (both males and females adults aged 18+ years) 4) Health workers caring for children with acute malnutrition (Male and females aged 18+ years; District and health facility administrators (male and female aged 18years 5) Policy level stakeholders, both male and female aged 18+ years) UNICEF Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
REFNo: SS3990ES

Suubi4PrEP will examine the effect of a multilevel intervention, combining HIV risk reduction that incorporates sessions on PrEP, peer supporters with lived experiences to facilitate linkage to and continued care, and economic empowerment components targeting financial barriers associated with PrEP access, PrEP initiation, uptake and adherence among AGYW in Uganda. Study aims are:

Aim 1: Examine the impact of Suubi4PrEP on PrEP initiation (primary outcome); and PrEP adherence (secondary outcome).

Aim 2: Examine the effect of Suubi4PrEP on hypothesized mechanisms of change (financial stability, PrEP stigma, self-efficacy, depressive symptoms, and social support) and intervention mediation.

Aim 3: Use mixed methods to explore multi-level factors that influence PrEP initiation and adherence.

Aim 4: Assess the cost and cost-effectiveness of the interventions.

Masaka, Nyendo
Lwengo, Kinoni
Kyotera, Kakuuto
Kalungu, Bukulula
Rakai, Kakuuto
Sembabule, Sembabule TC
Bukomansimbi, Mbiriizi
 Uganda 2025-06-20 7:41:25 2028-06-20 600 The target study population for the proposed Suubi4PrEP study is AGYW (15-24 years) living in HIV hotspots in the greater Masaka region of Uganda. Emancipated minors (below 18 years) will not need parental/caregiver consent. In Uganda, the National Guidelines for Research Involving Humans as Research Participants (NGHRP) define a child as any person below the age of 18. On the other hand, an emancipated minor is defined as an individual below the age of 18 who are pregnant, married, have a child, or are self-sufficient. Inclusion Criteria. Female between 15-24 years. AGYW will be screened for HIV risk as determined by the national risk screening tool developed by the Uganda National AIDS Control Program, in alignment with national PrEP guidelines. AGYW will be deemed to be at substantial risk, and eligible to participate in the study, if they report at least one of the seven high-risk sexual behaviors on the risk assessment tool. Exclusion criteria. A participant will be excluded if they are: 1) HIV Positive, 2) unable to understand the study procedures and/or participant rights during the informed consent process, or 3) they are unwilling or unable to commit to completing the study. If the potential participant has emergency needs (e.g., hospitalization), they will be referred for care instead. Peer Supporters. These will be women who are HIV negative, enrolled and adhering to PrEP. We expect to recruit at least four peer supporters at each of the 20 sites receiving the PS intervention component. National Institute for Mental Health Social Science and Humanities Clinical Trial Non-degree Award
Denis Nansera
ID: UNCST-2024-R004002
 Improving HIV testing among Children under five in Rural Uganda
REFNo: HS5829ES

The main objective of this study is to develop a traditional healer facilitated paediatric HIV testing program to improve access to paediatric HIV testing. To do this, we will first use qualitative study methods to determine factors that influence HIV testing among paediatric clients of TH and guide adaptation of the TH-facilitated HIV testing program for children. We will then implement a pilot study to evaluate offering paediatric HIV testing at traditional healer locations in southwestern Uganda.
 Uganda 2025-05-29 17:12:49 2028-05-29 465 Aim 1: Key stakeholders for Aim 1 will be defined as 1) adult caretakers of children ≤5 years old who receive care from TH in Mbarara District; 2) TH who care for more than 15 children under five each month; and 3) paediatric HIV clinicians from surrounding Health Centres III and IV. All participants will be 18 years or older, and able to provide informed consent. HIV clinicians must also have been in a patient-facing position (doctor, nurse, social worker, counsellor) for at least one year at the time of enrolment. Aim 2: The study population will be ten TH with monthly volume of 15 children five years old or younger, and 200 children 18 months to 5 years of age who receive care from these TH practices in Mbarara District. Inclusion criteria for TH: aged 18 or older, consent to recruitment of children at their practice, agree with goals of the study and associated procedures, and agree to attend all study-related training. Exclusion criteria will be the same as in Aim 1 above. Inclusion criteria for children are: 18 months to 5 years old; have a parent or caregiver who can provide informed consent; not previously tested for HIV in the past three months; and not previously known to be HIV-infected. National Institute of Mental Health Medical and Health Sciences Clinical Trial Non-degree Award
Nanyonga Elizabeth Monica
ID: UNCST-2025-R018232
 srd
REFNo: SIR516ES

GGGGGGGGGGGGGGGGGGGGGGGGGGGG
 Uganda 2025-05-27 9:30:38 2028-05-27 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA Engineering and Technology Clinical Trial Non-degree Award
Fred  Bulamba
ID: UNCST-2020-R014888
 Rule of THUMB: A multi-centre cluster trial evaluating the implementation of a perioperative care complex intervention to improve outcomes from haemorrhage during and after caesarean section in African hospitals
REFNo: HS5855ES

To evaluate the effect of the trial intervention on patient outcomes relevant to future trials.,To evaluate whether implementation of the ‘Rule of THUMB’ perioperative complex intervention increases risk assessment and improves diagnosis and compliance with proven interventions for haemorrhage during and after caesarean section.,
 Mbale, Hospital Cell
Uganda 2025-05-14 9:24:07 2028-05-14 600 Any patient who requires a caesarean section Department of Anaesthesia and Perioperative Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Mohamed Farah Mohamud
ID: UNCST-2025-R016841
 EFFECTIVENESS OF INTRAVENOUS PETHIDINE VERSUS INTRAVENOUS TRAMADOL FOR PERIOPERATIVE ANALGESIA IN UTERINE EVACUATION PROCEDURES AT JINJA REGIONAL REFERRAL HOSPITAL
REFNo: HS5960ES

1. To assess the effectiveness of intravenous pethidine versus intravenous tramadol for perioperative analgesia in uterine evacuation procedure at Jinja Regional Referral Hospital
2. To compare the secondary outcomes encountered among women administered with intravenous pethidine versus those with Intravenous Tramadol for perioperative analgesia in uterine evacuation procedures at Jinja Regional Referral Hospital
3. To compare the level of patient satisfaction with intravenous pethidine versus Intravenous tramadol in uterine evacuation procedures at Jinja Regional Referral Hospital

 Jinja, rippon
 Somalia 2025-04-30 7:27:21 2028-04-30 170 t All adult women with an indication for uterine evacuation admitted on gynecology ward of Jinja Regional Referral Hospital selfsponser Medical and Health Sciences Clinical Trial Degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments.
REFNo: HS5804ES

The primary objective of this trial is to provide continued access to the study medication received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) for participants who completed a Gilead parent study evaluating medications for HIV treatment.
Kampala, kampala
 Uganda 2025-04-11 16:20:58 2028-04-11 This study is not formally powered. The purpose of this study is to provide continued access to the study medication received in the parent study or to provide B/F/TAF to applicable participants who have completed a relevant parent study. Therefore, all participants who are on parent study medication and have completed a Gilead parent study evaluating medications for HIV treatment may be enrolled in this study dependent on eligibility. Participants who have completed a parent study and meet all eligibility criteria will be offered the opportunity to roll over to this study and receive the same regimen as in the parent study. Participants will also be allowed to switch to B/F/TAF when they enroll in this study if they meet the additional eligibility criteria. Gilead sciences Inc Medical and Health Sciences Clinical Trial Non-degree Award
Janet Nakigudde
ID: UNCST-2019-R000444
 TESTING MULTI-LEVEL SCALE-UP STRATEGIES TO IMPLEMENT A SCHOOL-BASED POPULATION APPROACH OF MENTAL HEALTH PREVENTIVE INTERVENTION: UGANDA
REFNo: HS5647ES

General Objective
The overall goal of this study is to address vertical and horizontal scale-up implementation framework gaps in Uganda. This study will test new recommended vertical scale-up and sustainability implementation strategies and study impact and underlying mechanisms when the new scale-up model is applied.
This research will guide the development of evidence-informed theoretical frameworks and processes to effectively institutionalize EBIs in LMICs such as Uganda. To achieve this goal, we will carry out 4 sequential steps (4 aims).
Specific Objectives
1.
To establish a cross-level partnership and strengthen stakeholders/leaders’ advocacy capacity to make evidence-based informed children’s mental health policy and practice decisions and to facilitate the EBI institutionalization through the educations system illustrated in figure 1.
2.
To develop implementation Protocols in collaboration with cross level partners (established in Aim 1) based on a new multilevel train-the-trainer scale-up framework to support the EBI/PD scale-up.
10
3.
Implement the new Protocols for scale-up and test the relative value of additional implementation supports intended to sustain teacher EBI practices through a Hybrid III cRCT.
4.
To explore underlying scale-up and sustainability implementation mechanisms.
 Arua, Lodonga, Arua Hill
Mityana, Busubizi, Kyanja
Gomba, Kabulasoke, Nakato
Masaka, Ndegeya, Kyanamukaka
Buikwe, Nkokonjeru, Kasenge
Kabale, Bukinda, Nyaruzinga
Bushenyi, Nyakabirizi
Sheema, Nyabubare
Western Region, Burahya
Iganga, Lwawu
Soroti, Kolojjo
Gulu, Awach
 Uganda 2025-04-11 16:03:54 2028-04-11 The study population and sample will consist of approximately 1,594 participants.46 Advocacy Leaders and Education System Leaders, including 10 from the Ministry of Education (MOE)/Ministry of Health (MOH), 12 from Teacher Training Colleges (TTCs), 12 from District Education Offices, and 12 head teachers (one from each school district/region). Additionally, 12 TTCs will be selected based on MOE prioritization and needs, with 96 tutors trained in Evidence-Based Intervention (EBI) implementation (8 per TTC). The study will also include 120 schools that are stratified and randomized, with approximately 1,200 teachers (10-15 per school) and 240 Peer Teacher Trainers (PTTs) selected and trained. The study population will consist of participants from diverse backgrounds. The age group of the participants will vary, with Advocacy Leaders and Education System Leaders typically being adults in their 30s and 40s, while teachers, tutors, and Peer Teacher Trainers (PTTs) will range from 20 to 50 years of age. The study will aim for gender balance, with an equal representation of male and female participants. Participants will be drawn from various ethnic groups across Uganda, including, but not limited to, Baganda, Basoga, Banyankole, Bakiga, and other tribal groups, ensuring inclusivity and representation from all regions of Uganda. The study will also reflect the diversity of the Ugandan educational system, capturing perspectives from urban and rural settings, as well as from different educational leadership and teaching roles. This study is sponsor by the United States National Institute of Mental Health through a collaboration with New York University, Department of Population Health, New York School of Medicine and Makerere University College of Health Sciences, Department of Psychiatry Medical and Health Sciences Clinical Trial Non-degree Award
FRED TWINOMUGISHA
ID: UNCST-2024-R003414
 THE ROLE OF INVOLVING PATIENTS IN PROMOTING HAND HYGIENE PRACTICES AMONG HEALTHCARE WORKERS IN MUKONO AND KAGADI DISTRICTS: A MIXED METHODS STUDY
REFNo: HS5449ES

1)To determine the level of knowledge and practice on hand hygiene among patients and health workers in selected healthcare facilities in Mukono and Kagadi districts, Uganda.
2)To explore the barriers and facilitators of involving patients in promoting hand hygiene practices among healthcare workers in selected healthcare facilities in Mukono and Kagadi districts, Uganda.
3)To explore the perceptions of healthcare workers on involving of patients in promoting hand hygiene practices in selected healthcare facilities in Mukono and Kagadi districts, Uganda.
4)To design and evaluate an intervention to improve hand hygiene among health workers.

Mukono, All
Kibaale, All
 Uganda 2025-04-11 14:30:15 2028-04-11 OBJECTIVE 1, 1292 This study will be conducted within the two districts of Mukono and Kagadi local governments. Study population: Patients admitted in Medical, Marternal and surgical wards aged 18 years and above. Tribes, all tribes both male and female. PROMISE CONSORTIUM PROJECT IN MAKERERE UNIVERSITY SCHOOL OF PUBLIC HEALTH Medical and Health Sciences Clinical Trial Degree Award
Ouma Simple
ID: UNCST-2021-R012820
 Harnessing Parental Social Networks to Increase HIV Testing Uptake Among Children of At-Risk Parents in Uganda: A Parallel-Group, Two-Arm Quasi-Experimental Implementation Science Protocol
REFNo: HS5741ES

Objectives:

Main Objective

To Adapt, implement and evaluate maternal SNS to improve access to HIV testing services among children of FSW.

Specific Objectives

1. To adapt SNS that harnesses maternal SN for HIV testing in children of female sex workers
2. To implement the adapted HASHTAG intervention targeting CARP in Gulu City
3. To evaluate the effectiveness and implementation science outcomes of the HASHTAG project
 Gulu, All Parishes
 Uganda 2025-04-11 14:13:08 2028-04-11 300 The target group for Intervention: We shall invite FSW with at least one child aged 0-17 years. For mothers to be categorized as FSW, each must have received money or goods in exchange for sexual services and consciously defined their activities as income-generating. In addition, we shall enrol active FSW who have been conducting sex work during the one year before setting up the cohort. Thus, maternal sex work status will be ascertained using three questions as follows: 1) Have you ever received money or goods in exchange for sexual services? 2) If yes, have you received money or goods in exchange for sexual services in the last year? 3) If yes, do you consider your receipt of money or goods for sexual services as income-generating? Mothers who answered "yes" to all three questions will be considered FSW. Conversely, mothers who answer "no" to either questions 2 or 3 will be considered non-FSW and be eligible to participate if they have been living in the same neighbourhood as the FSW in the past year before setting up the cohort (Attachment 1). We shall enrol only FSW who do not plan to move outside the greater Gulu in the one year following recruitment into the cohort. The comparator cohort: The comparative cohort will be matched 1:1 and will comprise non-sex working mothers matched on the neighbourhood, maternal age, child age, and child sex. The comparators must have lived in the same neighbourhood as FSW for at least the year before enrolment. Likewise, we shall enrol only non-FSWs who do not plan to move outside the greater Gulu in the one year following recruitment into the cohort. The children: Much as children of FSW are the direct target of the intervention, we shall not directly involve them as active participants in the cohort. Children of FSW will be randomly selected from both sexes and without stratification. Meanwhile, children of non-FSW will be matched to children on FSW in the neighbourhood, maternal age, child age, and child sex. IPHASA Medical and Health Sciences Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
 An open-label randomised controlled trial comparing novel combination and currently used antibiotic regimens for the empiric treatment of neonatal sepsis with a run-in confirmatory pharmacokinetic phase: NeoSep1
REFNo: HS5639ES

In Part 2, a secondary objective is to provide a ranking of clinically relevant antibiotic regimens based on other efficacy and safety secondary outcomes, as well as on health economic measures and the potential selection of resistance. The trial data will provide data to inform the balance between efficacy, safety, costs (and cost-effectiveness and equity, using health economic analysis) and propensity for resistance selection (based on microbiology tests) that will influence facility-level and national decision-making about adoption of studied regimens, and potential future inclusion in WHO guidelines.,In Part 2, the primary objective is to provide a ranking of eight different clinically relevant antibiotic regimens for first-line empiric and second-line (after lack of response/deterioration) treatment in terms of 28-day mortality as the primary outcome measure. It will flexibly compare these multiple different relevant treatment regimens to enable the trial to be run in sites worldwide with very different background rates of different pathogens, of resistance and patterns of routine clinical care by randomising each participant to locally relevant antibiotic regimens agreed prior to site initiation. The trial will ensure generalisability by focusing inclusion based on clinical symptoms associated with high mortality risk in the NeoOBS study, which have been developed into a novel neonatal sepsis severity score – the NeoSep Severity Score.,
 Kampala, Kawempe
Kampala, Mulago
 Uganda 2025-04-02 9:04:16 2028-04-02 400 for the MU-JHU site.Approximately 3000 participants across all participating sites. Neonates≤28 days of age hospitalised with clinical signs of neonatal sepsis. Global Antibiotic Research & Development Partnership (GARDP) Medical and Health Sciences Clinical Trial Non-degree Award
Sylvia Kusemererwa
ID: UNCST-2019-R001717
 A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises
REFNo: HS5607ES

To assess the efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without
hydroxyurea (HU)/hydroxycarbamide (HC) , on VOC rate in Sickle Cell Disease (SCD) patients aged 12 years and older who experience frequent vaso-occlusive crises (VOCs)
Primary Objective
1. To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCP managed (including VOCs leading to management at a health care facility or those via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
Secondary Objectives
1. To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without
hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).
2. To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:
 VOCs that are HCP-managed at a health care facility
 VOCs that are HCP-managed via remote consultation
Page 4 of 18
 VOCs that are self-managed without recommendations from HCP during the event
 VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event
 Masaka, Masaka
 Uganda 2025-04-02 8:58:47 2028-04-02 20 A total of 10-20 participants will be recruited at the MRC/UVRI and LSHTM Uganda Research Unit site. Recruitment will be competitive across sites and countries. Participants will be recruited through referrals from the sickle cell clinic at the Masaka Regional Referral Hospital. The clinic has a total of about 600 patients. The site will recruit participants according to the main study protocol using the inclusion and exclusion criteria stated. They will collect detailed locator information including addresses, telephone contact, and next of kin to facilitate phone and/or physical tracing during the follow-up phase of the study. LSHTM Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 A phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5274ES

Primary Objective: To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD
patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).

Secondary Objective: Key secondary objective:

To compare the efficacy of 5 mg/kg of
crizanlizumab versus placebo, with or without
hydroxyurea/hydroxycarbamide, on the
annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).

To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:
VOCs that are HCP-managed at a health
care facility
• VOCs that are HCP-managed via remote
consultation
• VOCs that are self-managed without
recommendations from HCP during the
event
• VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the
event

• To evaluate the time to first VOC that is HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.

To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.

To evaluate the duration of VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.

To evaluate the safety and immunogenicity of crizanlizumab 5 mg/kg over the 2-year study
period.

To explore the efficacy of crizanlizumab 5 mg/kg over the 2-year study period.

To explore the proportion of VOCs that are selfmanaged without recommendations from HCP during the event, versus VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned treatment period of 52 weeks.

To explore the proportion of VOCs that are HCP-managed via remote consultation versus VOCs that are HCP-managed at a healthcare facility between treatment arms over the planned 52-week treatment period.

To explore the incidence rates of all VOCs,
VOCs that are HCP-managed at a healthcare
facility, VOCs that are HCP-managed via remote consultation, VOCs that are HCP-managed,VOCs that are self-managed without
recommendations from HCP during the event,
VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the event, by treatment arm.

To explore quality of life in each treatment arm (ASCQ-Me Short Forms: emotional impact, sleep impact, and joint stiffness).

To explore healthcare facility resource utilization (inpatient hospital admission, emergency room visit, urgent care/clinic visit, infusion center visit)between treatment arms over
the planned 52-week treatment period.

To explore the pharmacokinetics (PK) profile of crizanlizumab at 5 mg/kg.

To explore the pharmacodynamics (PD) (Pselectin inhibition) of crizanlizumab at 5 mg/kg.

To explore biomarkers [p-selectin (free and
total)] and CRP].

To explore exposure-response relationship.
 Wakiso, Lubowa
 Uganda 2025-04-02 8:43:56 2028-04-02 10-15 SCD participants aged 12 years and older who experienced at 4-12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in the 12 months prior to screening visit. Participants who have been taking HU/HC for at least 6 months at a stable dose for at least 3 months and plan to continue taking at the same dose and schedule until the participant has reached 52 weeks of study treatment will be permitted. Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to the screening visit. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Moses Galiwango
ID: UNCST-2024-R015239
 INTEGRATED FEMALE SEXUALLY TRANSMITTED INFECTION TESTING FOR HIV EPIDEMIC CONTROL THROUGH PREP (IN-STEP)
REFNo: HS5715ES

a) To conduct an individually randomized effectiveness implementation trial of SRST plus cSTI testing to increase PrEP use among African women at high HIV risk.
b) To perform a mixed-methods, implementation science evaluation of female cSTI testing for improving PrEP use for HIV prevention.
c) To determine the most efficient, population-level female cSTI testing strategies to reduce HIV incidence in African settings.

Rakai, All parishes in the mentioned subcounty
Kyotera, All parishes in the mentioned subcounty
Lyantonde, All parishes in the mentioned subcounty
 Uganda 2025-03-25 11:13:20 2028-03-25 5000 The targeted population is adolescent girls and women aged 15 - 39 years of age National Institute of Allergy and Infectious Diseases, R01AI177132 (Financial support); Abbott Laboratories (Material support) Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SURVEY, SAFETY AND EFFICACY OF HERBAL PRODUCTS USED FOR MALARIA PROPHYLAXIS AND TREATMENT IN UGANDA.
REFNo: HS5468ES

To conduct a survey of herbal medicinal products used for malaria prophylaxis and treatment, evaluate their safety and prophylactic efficacy among school-age children (8-15yrs) in Kibuku district, Uganda.
1. To identify herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
2. To evaluate the artemisinin content of herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
3. To determine the antiplasmodial activity (IC50) of herbal medicinal products used for malaria prophylaxis and treatment in Uganda.
4. To evaluate the safety of herbal medicinal products used for malaria prophylaxis among school age children (8-15 years) in Kibuku district in eastern Uganda.
5. To determine malaria incidence among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku district in eastern Uganda.
6. To determine prevalence of parasitaemia among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku in eastern Uganda.

 All Districts, NA
Kibuku,
Uganda 2025-03-14 19:08:33 2028-03-14 222 participants for the trial (111 per study arm) 8 to 15 years of age, both male and female, all tribes accessible. The Government of Uganda through the Science, Technology, and Innovation Secretariat - Office of the President (STI-OP) Medical and Health Sciences Clinical Trial Non-degree Award
Victor Musiime
ID: UNCST-2021-R013794
 A global phase 3, randomised, double-blind and placebo-controlled study evaluating the efficacy and safety of etavopivat in adolescents and adults with sickle cell disease
REFNo: HS5637ES

1. To demonstrate superiority of
treatment with etavopivat
versus placebo in adolescents
and adults with SCD.
2. To evaluate clinical efficacy
measures of etavopivat treatment
versus placebo in adolescents
and adults with SCD
3. To assess clinically meaningful
improvement in fatigue and
functional exercise capacity
and QOL measures of
adolescents and adults with
SCD taking etavopivat
treatment compared to placebo
 Wakiso, Sabagabo
Kampala, Mulago
Jinja, Jinja
 Uganda 2025-03-14 17:26:26 2028-03-14 408 12-17, 18 and above, male female all tribes Novo Nordisk A/S Medical and Health Sciences Clinical Trial Non-degree Award
Margaret Nagawa
ID: UNCST-2022-R009705
 EARLY NUTRITIONAL INTERVENTION FOR NUTRITIONALLY AT-RISK INFANTS UNDER 6 MONTHS OF AGE TO REDUCE MALNUTRITION IN THE FIRST YEAR OF LIFE
REFNo: HS3503ES

5. To assess the maternal and health worker perceptions on the integrated intervention package.,4. To assess the effect of an early integrated family intervention program for LBW and undernourished children u6m on growth in the first year of life.,3. To understand the barriers and facilitators to the integration of maternal mental health care and community-based management of malnutrition in infants u6m of age.,2. To assess the prevalence of maternal mental health among caregivers of u6m infants.,1. To determine the factors associated with malnutrition among infants u6m of age and challenges caregivers of LBW and undernourished infants face. ,2. To assess the prevalence of malnutrition among infants u6m and their associations, To assess the effect of an early integrated nutrition intervention for nutritionally at-risk infants u6m of age in reducing malnutrition in the first year of life. ,
 Adjumani, Adjumani
 Uganda 2025-03-14 16:37:34 2028-03-14 300 mother baby pairs Infants under 6 months of age. and caregivers of infants under six months of age. sex: males and females Tribe: refugees and host communities self funded Medical and Health Sciences Clinical Trial Degree Award
Schola  Matovu Nakachwa
ID: UNCST-2022-R011040
 Development and Testing of BAJJAJJA: An Intervention to Promote Economic Empowerment and Health of Grandmothers who Provide Primary Care for Grandchildren in Uganda
REFNo: SS3611ES

Main Objective
The study’s objective is to refine and test the feasibility and acceptability of my innovative intervention, BAJJAJJA: Building A Joint Action for JaJJAs which couples an income- generating activity (IGA) with nurse-facilitated group health coaching. This objective is informed by the NIH Stage Model of behavioral intervention development.

Specific Objectives
Aim 1: To refine and adapt the BAJJAJJA intervention through a collaborative and iterative feedback process with a diverse community group of 18 members. In a series of sessions, I will iteratively engage diverse community groups (nurses, local officials, IGA experts, and GMCs) and use cognitive interviewing to gain feedback on the appropriateness of study measures, content, delivery, and intervention format.
Aim 2: To test the feasibility, acceptability, and preliminary efficacy of the BAJJAJJA intervention in improving economic and health outcomes among 24 Ugandan GMCs. Over a 12-month period and at three time points of assessment, I will use a mixed methodology with a quasi-experimental design to collect data that will be examined to assess the feasibility, acceptability, and preliminary efficacy of the intervention on participants’ household income and health outcomes.
Aim 3: To explore the barriers and facilitators to (3a) maintenance of the BAJJAJJA individual intervention benefits (e.g., physical activity level and frequency) and (3b) sustainability of the IGA activities (e.g., grandmothers’ accessing external supports such as community resources) at 6 months post-intervention. Following a mixed methods approach, the 24 GMCs from Aim 2 will be interviewed to further evaluate the long-term maintenance and sustainability of the intervention. Health assessments, interviews, and IGA site visits will be used to explore the intervention outcomes and benefits at 6 months post-intervention.

Buikwe, Kiteza
 USA 2025-03-10 12:23:29 2028-03-10 24 Grandmother Caregivers 1. Grandmothers: Ugandan GMCs who are (a) > 50 years (considering the average reproductive age range in Uganda of 15-49 years), (b) Luganda-speaking (commonly spoken language), (c) primary caregivers for at least one minor grandchild (< 18 years) for > 6 months, and (d) able to perform activities of daily living (e.g., cooking, bathing) without assistance. 2.Community Advisory Board: 10 key informants: Local elected community leaders ( LCs), healthcare professionals, nurses from local health centers and a village health team member, IGA experts, and grandmothers. Participants will be identified by LC leaders or referred by other participants using a snowball sampling technique. Participants are female (grandmother caregivers) with no tribal restrictions as long as she can speak luganda NIH JOHN E FORGATY International Center Social Science and Humanities Clinical Trial Non-degree Award
Pauline Byakika-Kibwika
ID: UNCST-2019-R001206
 Randomized trial to evaluate the efficacy and safety of select therapeutic agents in the treatment of Ebola Disease (TOKOMEZA - Ebola Disease Therapeutics)
REFNo: HS5686ES

This is an open-label, adaptive, randomised platform clinical trial to evaluate the impact of 278 potential treatments on mortality in patients with Ebola Disease
 All Districts, Not specific
 Uganda 2025-03-07 18:39:19 2028-03-07 180 All age groups, sex, and tribes that are eligible for recruitment. Ministry of Health of Uganda and World Health Organization Medical and Health Sciences Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB IN COMBINATION WITH PHESGO→ VERSUS PLACEBO IN COMBINATION WITH PHESGO→ AS MAINTENANCE THERAPY AFTER FIRST LINE INDUCTION THERAPY IN PARTICIPANTS WITH PIK3CA‑MUTATED HER2‑POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER (INAVO122)
REFNo: HS5649ES

This study will enrol particpants
Kampala, Mulago
Uganda 2025-03-07 18:26:49 2028-03-07 20 Adult females above 18 years of age with breast cancer F.Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
Angelina Kakooza-Mwesige
ID: UNCST-2020-R014529
 EVALUATION OF THE IMPACT OF THE THREE TIER INTERVENTIONS FOR DISABILITY IN EARLY CHILDHOOD (IDEC) PROGRAMME IN UGANDA
REFNo: HS5596ES

GENERAL OBJECTIVE

The overall aim of this study is to evaluate the impact of the three-tier IDEC model piloted in the two districts of Mubende and Kassanda in Uganda, with a twofold purpose: (1) to improve intervention design and management and (2) to inform decisions about future investment and scale-up by establishing evidence and impact.

SPECIFIC OBJECTIVES.

Primary objectives
1. To determine the coverage of vision screening at 0-3 months and developmental screening at 9 and 18 months in the study sites.
2. To determine the change in functional abilities in children receiving the Tier 2 intervention.
3. To evaluate effects of the individualised (Tier 3) program at regular intervals (at least every 3 months) on child and family functioning, well-being and participation.
Secondary objectives
1. To determine the change in knowledge and skills in parental/caretaker after the Tier 2 interventions.
2. To determine the change in parental/caretaker level of stress after Tier 2 interventions.
3. To determine the change in parental/caretaker level of stress after Tier 3 interventions.

4. To establish the extent to which children with developmental delay and disability Tier 1 are included in ECD programmes
5. To establish the extent to which children with developmental delay and disability tier 2 are included in ECD programmes. (This could be a compliance or fidelity issue
6. To determine how well (fidelity) the health workers provided the Tier 2 and 3 interventions.
7. To determine compliance with Tier 2 and Tier 3 interventions by the caregivers.
8. To determine family satisfaction with all three tiers of the program, including both children that failed and children who passed the screening assessment (Tier I).
9. To determine the costs and cost-effectiveness of the entire program.
10. To assess the likelihood of continuation
Mubende, Kiyuni
Mubende, Kiyuni
 Uganda 2025-03-04 13:40:10 2028-03-04 296 Children aged 0-3 months, Children aged 6-36 months,Children with developmental delay, at risk of Celebral Palsy and Austism UNICEF Medical and Health Sciences Clinical Trial Non-degree Award
ISMAHIL ADENIYI ADEKUNLE
ID: UNCST-2024-R002602
 EFFECTS OF ETHYL-ACETATE FRACTION OF Bidens pilosa LEAVES ON TESTES AND PITUITARY GLAND OF MALE MICE EXPOSED TO BISPHENOL A
REFNo: HS5372ES

The purpose of this study is to evaluate the impact of B. pilosa on testicular integrity and the pituitary gland of male mice exposed to BPA.
1.3.1 Specific Objectives
i. To assess the effect of B. Pilosa on spermatogenic metrics of the testes such as sperm motility, sperm count, morphology, agglutination, and vitality using routine and extended semen analysis.
ii. To determine the impact of B. pilosa on serum concentration of follicle-stimulating hormone, testosterone, and luteinizing hormone using enzyme-linked immunosorbent assay (ELISA) following BPA exposure.
iii. To assess the changes in testicular oxidative stress biomarkers (such as CAT, SOD, and GSH) and lipid peroxidation using MDA.
iv. To assess the histology, histochemical, and immunohistochemical changes in the testes and pituitary gland following treatment with B. pilosa in BPA exposure using Masson Trichrome, Periodic Acid Schiff (PAS), Hematoxylin and Eosin (H&E), Caspase 3, antiproliferating cell nuclear antigen (PCNA), Bcl-2, alpha-smooth muscle actin (α-SMA), and Bax.

 Bushenyi, Kampala International University, Western Campus
 Nigeria 2025-03-03 11:40:21 2028-03-03 30 animals Animals will be divided into five groups, with six animals in each group (n=6). Group 1 is the control, 2 ml/kg bw of distilled water. Group 2—100 mg/kg/day of BPA Group 3—100 mg/kg/day of BPA + low dose of B. pilosa (250 mg/kg). Group 4—100 mg/kg/day of BPA + medium dose of B. pilosa (500 mg/kg). Group 5: 100 mg/kg/day of BPA + high dose of B. pilosa (1000 mg/kg) All administration will be done via oral administration for 5 weeks (35 days) because sperm maturation in mice takes about 35 days; B. pilosa will be administered after 1 hour of treatment with BPA. At the conclusion of the administration period on the 35th day, as per the approved protocol, animals from all groups will be euthanized after receiving ketamine. Blood samples will be collected from the animals via cardiac puncture and transferred to a plain sample bottle to allow coagulation of the cellular components of the blood. The blood sample is then centrifuged for the collection of serum. The collected serum will be used for hormonal assay (testosterone, LH, and FSH) and determination of oxidative stress biomarkers (CAT, SOD, and GSH). Adeniyi A. Ismahil (self sponsored) Medical and Health Sciences Clinical Trial Degree Award
Nazarius Tumwesigye Mbona
ID: UNCST-2019-R000664
 COBIHA- A COMMUNITY BASED INTERVENTION AGAINST HARMFUL USE OF ALCOHOL IN A RURAL SETTING: A pilot study around lake Bunyonyi in Kigezi, Uganda
REFNo: HS5521ES

2.To explore reasons for harmful use of alcohol, and perceptions on effective and acceptable ways of reducing this.,1.To conduct a pilot survey to establish the level of harmful use of alcohol and factors associated with the behaviour , to fill the evidence gap on effective community interventions, the current burden of harmful use of alcohol, and community perceptions of the burden of harmful alcohol use in rural Uganda,
 Kabale, Mwendo
Kabale, Bwama
Rubanda, Kagarama
Rubanda, Butobole
Rubanda, Kabere
 Uganda 2025-02-20 18:51:21 2028-02-20 0 All adults aged 18 and above with alcohol harmful use National Institute for Health and Care Research Medical and Health Sciences Clinical Trial Non-degree Award
Christine  Muhumuza
ID: UNCST-2023-R008646
 Improving Family Wellness for Couples in Central Uganda 2024-2029
REFNo: HS5523ES

The study aims are to:

(1) In a cluster randomised trial, compare the efficacy of the FH=FW intervention vs. a time/attention matched comparator intervention at increasing modern contraceptive use and reducing unintended pregnancy among couples with an unmet need for family planning through 24-months, and identify potential mediators of the intervention effect.

(2) Determine the intervention’s effect on, and determinants of, contraceptive continuation.

(3) Through a mixed-methods process evaluation, explore factors affecting the implementation of the intervention in order to improve feasibility, acceptability, and the likelihood of future adoption and sustainment
 Kalungu, Kalungu
Gomba, Kinoni
Mpigi, Bulunda A
Kalungu, Lukaya
Gomba, Kisozi
Mpigi, Muduma
Kalungu, Kabungo
Kalungu, Bbaala
Kalungu, Kabale
Kalungu, Kalungi
Kalungu, Kasambya
Kalungu, Kabungo
Gomba, Bulwadda
Gomba, Kasaka
Gomba, Kyayi
Gomba, Bukalagi
Gomba, Mpenja
Gomba, Ngomanene
Mpigi, Bunjako
Mpigi, Mitala-Maria
Mpigi, Butoolo
Mpigi, Kampiringisa
Mpigi, Katende
Mpigi, Sekiwunga
Mpigi, Kitakyusa
Mpigi, Nsamu/Kyali
Mpigi, Bujuuko/Bulamu
Mpigi, Nindye
 Uganda 2025-02-20 17:09:28 2028-02-20 We will sample 4 health centers (clusters) in each of the 3 districts. We expect that the 12 clusters will yield ~1704 participants (852 couples) across the two study arms. Married men and women (couples) aged 18-49 of any tribe in the selected districts. National Institute of Child Health and Development (NICHD), grant number: R01HD113806 Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Muhanguzi
ID: UNCST-2019-R001101
 Evaluation of the Safety, Efficacy and Stability of SangaSupa®-30% Emulsifiable Concentrate [EC]: A Randomised Single-Blinded Positive Controlled Multi-Site Acaricide Field Trial
REFNo: NS910ES

General objectives
To determine the efficacy, safety, and stability of SangaSupa® (Sanga Vet. Chem. Ltd, Kampala Industrial Park, Namanve ) when applied onto cattle by hand spraying and plunge dipping for tick control.
Specific objectives
The specific objectives of this acaricide field trial will to determine;-
i. efficacy of SangaSupa® when applied onto cattle by hand spraying and plunge dipping for tick control.
ii. safety of Sangasupa® when applied onto cattle by hand spraying and plunge dipping for tick control.
iii. Stability of Sangasupa® when applied onto cattle by plunge dipping for tick control.
Kyenjojo, Ntuutu
Kyenjojo, Ruhoko
Kyenjojo, Hima
Serere, Bugondo
Serere, Okidi
Kumi, Kachaboi
 Uganda 2025-02-14 15:53:01 2028-02-14 n = 797 cattle above three months. For details please refer to the protocol Cattle above 3 months , both male and female. All cattle breeds will be eligible for recruitment. The detailed inclusion and exclusion criteria are described in the main protocol. The Government of Uganda Natural Sciences Clinical Trial Non-degree Award
Joseph  Matovu KB
ID: UNCST-2020-R014654
 Reducing hazardous alcohol use and optimizing treatment as prevention among men living with HIV in risk environments
REFNo: HS5558ES

Understand barriers and facilitators in the inner and outer context for implementing the components of Kisoboka within the routine clinical setting to inform future widespread implementation guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework and documentation of intervention and implementation costs. ,Assess the impact of the Kisoboka intervention and its components on measures of psychological, physical, and socioeconomic well-being that capture frequent comorbidities of people living with HIV and are associated with achieving successful treatment as prevention,Determine the efficacy of the Kisoboka intervention and its components on alcohol and HIV outcomes among hazardously drinking men living with HIV in Uganda in a 2x2 factorial RCT. ,Assess the efficacy of Kisoboka and its components (BE & MI) to gain insight into Kisoboka’s potential effect, determine if BE and MI interact and examine barriers and facilitators for implementing Kisoboka within routine clinical settings to inform future widespread implementation.,
 Buikwe, Kawolo
Buikwe, Buikwe Mbiko
Buikwe, Nyenga
Buikwe, Ngogwe
Buikwe, Buikwe Ssi
Buikwe, Makonge
Buikwe, Buikwe Njeru
Nakasongola, Nakasongola Town
Nakasongola, Lwampanga
Nakasongola, Kalungi
Nakasongola, Nabiswera
Nakasongola, Nakayonza
 Uganda 2025-02-14 15:19:41 2028-02-14 820 Eligibility is men aged ≥18, living with HIV, residing in a fishing community (on most days/nights), AUDIT-C positive (≥4) indicating potential hazardous alcohol drinking and >6 months since initial ART initiation, last VL was detectable or missing, not planning to move from the area within the next 6 months and have their own mobile phone and can be reached via phone. National Institute of Health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
David Mukunya
ID: UNCST-2022-R010707
 A phase III, randomized, open-label, clinical trial to evaluate the safety and efficacy of emollient therapy for very low birthweight infants (<1500g) in Uganda in promoting survival, health, growth and development compared to no emollient treatment
REFNo: HS5338ES

To evaluate the efficacy of emollient therapy with SSO – compared to standard care without use of emollients – among hospitalised very low birth weight (VLBW, <1500g) infants in Uganda on: the rate of in-hospital mortality, serious infections, hypothermia, growth, intraventricular haemorrhage, and skin condition; maternal depression and anxiety; maternal and neonatal interaction; infant growth and neurodevelopment at 12 month corrected age (chronological age reduced by the number of weeks born before 40 weeks of gestation); and infant mortality.
Mbale, Hospital Cell
 Uganda 2025-01-31 7:21:53 2028-01-31 1242 Preterm infants who are admitted to MRRH-NNU. Inclusion criteria: • Admission weight 800g to <1500g • Admission age < 24 hours • Mother +/- father who can understand English, Luganda, Lugwere, Ateso or Lumasaba • Mother +/- father who are willing and able to give verbal consent for participation of their infant in the study. • Mother aged 15 years or above Exclusion criteria: • Mother or father are not willing or are unable to give written, informed consent for participation of their infant in the study within 48 hours of admission to the NNU • Second or later birth order or a multiple pregnancy, when the first or an earlier birth order infant is eligible for participation • Infants with major congenital abnormality e.g. gastroschisis, cyanotic heart disease, upper airways abnormality • Critically ill infants at time of enrollment: Babies with apnoeas requiring frequent stimulation or bag mask ventilation; shock (heart rate >200 beats per minute and/or Mean Arterial Pressure <Gestational Age); Severe respiratory distress (Downs Score ≥8); Respiratory Failure (Oxygen saturation <90% on oxygen therapy/bCPAP) • Infants with generalized skin disease or a structural defect involving >5% body surface area likely to produce a defect in epidermal barrier function. • Mother and father unwilling to come back to Mbale RRH for follow-up Mbale Clinical Research Institute Medical and Health Sciences Clinical Trial Non-degree Award
JUDITH NASSAAZI
ID: UNCST-2023-R007664
 Comparing in-person versus virtual postoperative review appointments for children following guided growth surgery at CORSU Hospital, Uganda
REFNo: HS5268ES

Study Objectives
Primary objectives
To compare the show-rates of in-person versus virtual/telehealth post-operative review appointments for children following guided growth surgery at CoRSU Hospital

Secondary objectives.
1.To compare parental satisfaction of in-person versus virtual appointments
2.To determine the factors that facilitate in-person and virtual appointments following guided growth surgery.
3.To compare the rate of post-operative complications following in-person follow-up versus virtual follow-up
 Wakiso, KISUBI
 Uganda 2025-01-22 10:12:27 2028-01-22 82 FROM AGE 3 TO 12 IN GIRLS AND 3 TO 16 IN BOYS ALL TRIBES AND BOTH MALES AND FEMALES ARE INCLUDED IN THE STUDY SELF SPONSORED AND PARTIAL FUNDING BY UNIVERSITY OF CARLIFORNIA SANFRANCISCO Medical and Health Sciences Clinical Trial Non-degree Award
Justine Namuli Diana
ID: UNCST-2021-R011844
 ENHANCING COMPREHENSION OF INFORMED CONSENT IN RESEARCH INVOLVING PATIENTS WITH PSYCHOTIC DISORDERS USING AUDIO-VISUAL AIDS
REFNo: HS5358ES

To evaluate the comprehension of informed consent, identify key factors that are associated with comprehension of consent, determine the feasibility, acceptability, and preliminary effectiveness of audio-visual aids on enhancing the comprehension of consent information during the consenting process in research involving individuals with psychotic disorders
 Kampala, Butabika
 Uganda 2025-01-10 12:00:57 2028-01-10 study 1=418, study 2,8 participants, study 3,60 participants,study 4 not less than 18 Ugandans aged 18 years and above, all gender Makerere University international bioethics research training PhD program (GRANT NUMBER D43TW010892) Medical and Health Sciences Clinical Trial Degree Award
Francis Ssali
ID: UNCST-2021-R012134
 A5409: A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)
REFNo: HS4036ES

1.2 Primary Objectives

1.2.1 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for each experimental treatment arm to the SOC arm.

1.2.2 To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3 Secondary Objectives

1.3.1 To compare time to stable culture conversion by MGIT liquid culture by week 8 for each experimental treatment arm to the SOC arm.

1.3.2 To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.3 To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.4 To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.5 To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.

1.3.6 To compare a composite of efficacy and safety outcomes using a risk-benefit approach for each experimental treatment arm to the SOC arm.

1.3.7 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.

1.3.8 To compare durable cure by 52 weeks after treatment initiation in each experimental treatment arm to the SOC arm.


 Kampala, Kampala
Wakiso, Wakiso
 Uganda 2024-12-23 12:34:14 2027-12-23 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm. The JCRC site plans to recruit at least 50 participants Participants with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. National Institute of Allergy and Infectious Diseases (NIAIDS) Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 A Phase 1b, Age De-Escalation/Dose Escalation Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in an African Population of Adults and Children in a Setting of Perennial Malaria Transmission
REFNo: HS5298ES

Primary Objective. To assess the safety and tolerability of MAM01. Secondary Objectives. To assess the safety of MAM01. To characterize the PK of MAM01 following SC, IV, and IM administration of MAM01. To assess the formation of anti-drug antibodies (ADAs) to MAM01. Exploratory Objectives. To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to a placebo. To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to placebo. To assess the protection of MAM01 against events of malaria illness (first/only and all episodes). To correlate MAM01 concentration with Pf infection risk. To assess the complexity of Pf infection following administration of MAM01 or placebo.
Tororo, Osukuru
Tororo, Kayoro
Tororo, Magola
Kampala, Lubowa
 Uganda 2024-12-23 12:23:27 2027-12-23 139 Adults and children, male and female Bill & Melinda Gates Medical Research Institute (Gates MRI) Medical and Health Sciences Clinical Trial Non-degree Award
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
 A phase III, Multicenter, Randomized, Placebo Controlled, Double blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5365ES

To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52 week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the Screeening visit
To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period: • VOCs that are HCP-managed at a health care facility • VOCs that are HCP-managed via remote consultation • VOCs that are self-managed without recommendations from HCP during the event • VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event
To evaluate the time to first VOC that is HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
 Eastern Region, All parishes
 Uganda 2024-12-23 11:34:49 2027-12-23 315 Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to <18 years old and adults include participants aged 18 years and older. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Solomon Kibudde
ID: UNCST-2021-R013747
 PHASE II RANDOMIZED NON-INFERIORITY TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOR LOCALLY ADVANCED CERVICAL CANCER IN UGANDA.
REFNo: HS5348ES

1) To compare the incidence of grade 3+ gastrointestinal and genitourinary toxicity at 1 year post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) and conventional fractionated radiotherapy (45 Gy in 25 fractions) in women with cervical cancer in Uganda.
2) To evaluate and compare local control and cervical cancer-specific survival rates at 1 year after hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional radiotherapy (45 Gy in 25 fractions).
3) To determine the association between stage-adjusted mean squamous cell carcinoma antigen (SCC-Ag) at 1-month post-treatment with the Progression-free survival at 1- year post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) or conventionally fractionated radiotherapy (45 Gy in 25 fractions).
4) To compare the costs of healthcare to patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).
5) To evaluate patient-reported outcomes and quality of life in patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).

 Kampala, Mulago
 Uganda 2024-12-23 11:01:22 2027-12-23 120 participants To be considered eligible for this study, participants must meet the following criteria: 1. Females aged 18 years or older 2. Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment. 3. FIGO 2018 Stage IB3, IIA, IIB, IIIA, IIIB, IIIC, or IVA. 4. Able to provide written informed consent in English, Luganda, Runyankole, Lango or Lusoga. 5. Willing to attend post-treatment follow-up for up to 12 months. 6. Fit for concurrent chemotherapy with cisplatin. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2. 8. Adequate bone marrow function: Absolute neutrophil count ≥ 1,500 cells/mm3 (1.5 x 109/L); Platelets ≥ 100,000 cells/mm3 (100 x 109/L); haemoglobin ≥ 9.0 g/dL; Leukocyte count ≥ 4,000 cells/mm3 (4.0 x 109/L). 9. Adequate renal function: creatinine clearance > 60 mL/mins, calculated using the Cockcroft-gault equation for women. 10. Adequate liver function: AST and ALT < 3 times the upper limit of normal (ULN); and Total bilirubin < 2 x ULN unless attributed to the use of antiretroviral therapy (ART). Exclusion criteria Participants will be excluded from the study if they meet any of the following criteria: 1. Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the radiotherapy field, and dose prescriptions because they tend to have a higher risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention. 2. Clinical and/or radiological evidence of distant metastases. 3. Prior pelvic or abdominal radiotherapy. 4. Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment. 5. History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment. 6. Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may result in fetal malformations, growth retardation, or even fatal death. Secondly, their physiological changes alter the pharmacokinetics and pharmacodynamics of concurrent chemotherapy. Therefore, to protect the health of the mother and the unborn child, pregnant women will be excluded from the study. Patients who are found to be pregnant after enrollment will have the study procedures terminated. 7. Concurrent untreated invasive malignancy 8. Uncontrolled concurrent medical/psychiatric diagnosis that would limit compliance with study requirements Uganda Cancer Institute, Varian Medical Systems, and UCI-FHCC Medical and Health Sciences Clinical Trial Degree Award
Jackson Orem
ID: UNCST-2021-R012016
 A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings
REFNo: HS4073ES

To describe the incremental cost-effectiveness ratio per QALY gained (as assessed by PROPr) between PLD and PTX,To assess quality of life across PROMIS domains (i.e., cognitive function, physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) with the PROPr tool at start of therapy, mid-treatment, and after treatment with PLD and PTX ,To describe the cost of therapy across AMC sites in sub-Saharan Africa to deliver both PLD and PTX by micro-costing analysis for goods and time-in-motion analysis for services. ,To estimate the objective response rate (defined as the sum of complete and partial responses) for AIDS-KS, response duration and overall survival in each treatment arm. ,To evaluate whether there is sufficient evidence to conclude that PLD is non-inferior to PTX in people with severe AIDS-associated KS receiving concomitant ART in resource-limited settings. ,
 Kampala, Mulago
Uganda 2024-12-10 14:39:24 2027-12-10 130 participants overall and up to 40 participants in Uganda This study will be done in adults above 18 years, both male and female of all tribes, and will recruit participants with HIV-associated Kaposi Sarcoma in Uganda. AIDS Malignancy Consortium Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 Open-label, Multicenter Immunogenicity and Safety Trial of MVA-BN® Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections
REFNo: HS5281ES

To assess immunogenicity of the MVA-BN standard regimen in eliciting neutralizing antibodies against vaccinia virus in children compared to adults. To assess the safety and reactogenicity of the MVA-BN standard regimen in children and adults. To assess neutralizing antibody response to the MVA-BN standard regimen. To assess durability of neutralizing antibody response to the MVA-BN standard regimen.
Wakiso, Entebbe
Mbarara, Mbarara
 Uganda 2024-11-22 17:19:29 2027-11-22 300 Participants The trial population for this trial will be both pediatric (2 to <12 years of age) and adult (18 to 50 years of age) healthy volunteers. Both males and females will be recruited at the research sites in Entebbe and Mbarara. Potential volunteers will be approached in their communities, given information about the trial and those who show interest will be requested to come to the research sites. Bavarian Nordic A/S and funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssinabulya
ID: UNCST-2021-R004352
 ImpleMEntation of a Digital-first care deLiverY model for heart failure in Uganda (MEDLY Uganda)
REFNo: HS4581ES

In this study, we will implement a digital-first, multi-component strategy for HF (Medly Uganda) and evaluate both implementation and clinical outcomes. The primary objective is to assess the implementation and clinical effectiveness of a digital-first implementation strategy to improve HF self-care in Uganda. We will conduct a stepped-wedge, cluster randomized trial in outpatient departments at 6 Ugandan RRH. The co-primary outcomes will be the Self-Care of HF Index (implementation) and the composite of mortality and HF hospitalization (clinical effectiveness). The secondary objectives will include the following. Conduct a mixed method process evaluation to inform iterative adjustments to the implementation process. We will use a community-engaged approach to systematically collect qualitative and quantitative process data at pre-determined time points based on the Learn-As-You-Go design and make contextually appropriate implementation adaptations. Prior to recruitment, we will also explore patients’ journeys to heart failure diagnosis in Uganda through a qualitative component by conducting in-depth interviews. The aims of this work will be to explore factors associated with patient’s journeys to heart failure diagnosis, including descriptions of initial symptoms, progression, health care referral journey, barriers and facilitators to care, and role of health education and self-care awareness. We will assess the implementation fidelity and sustainability of Medly Uganda with a focus on reach, adoption, and maintenance. Using Medly Uganda meta data from patients (app) and providers (dashboard), we will identify patterns and predictors of usage. We will interview patients and providers to explore these findings, and ensure implementation fidelity. We will also explore patient and provider perspectives on the sustainability of Medly Uganda, using semi-structured interviews to explore patient and provider barriers and facilitators of long-term use, to surface strategies that would optimize Medly Uganda implementation over time. We shall explore cost, cost effectiveness, and sustainability factors for Medly Uganda. We will collect and examine cost data from patients and facilities examining the unit cost (cost per HF patient treated and per HF patient controlled) of control and Medly Uganda scenarios both from a financial and societal perspective. Primary outcomes for cost effectiveness analysis will be the Incremental Cost-Effectiveness Ratio per patient treated and per death averted.
Arua,
Lira,
Mbale,
Masaka,
Mbarara,
Kabarole,
Uganda 2024-11-18 22:56:37 2027-11-18 576 We will consecutively recruit patients 18 years or older presenting for HF care at the medical outpatient NCD and/or cardiac clinics at the 6 participating sites, each a Ugandan public sector Regional Referral Hospital (RRH) located in Arua, Fort Portal, , Lira, Masaka, Mbale and Mbarara. For the secondary objectives 1 and 2 of this study, we will recruit patients, implementers and administrators to participate in the process evaluation, and in reflections on implementation and sustainability. We expect to recruit 12 implementers (2/site at minimum), 22 administrators (2/site, 6 regional representatives, and 4 MoH) as well as 72 patients (8-12 at minimum/site) for qualitative assessment over the course of the study. Our qualitative component will recruit patients 18 years or older with recently diagnosed HF (within past three months), presenting for care at Uganda Heart Institute, or Arua, Masaka, and/ Mbale RRH. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Deo Wabwire Ogema
ID: UNCST-2021-R013932
 A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB) Version 2.0, Dated 21 Mar 2024
REFNo: HS5088ES

Primary objectives

(i)To compare Mycobacterial Growth in Tube (MGIT) liquid culture Time to Positivity (TTP) slope over the first 6 weeks of treatment for each experimental treatment arm to the standard of care (SOC) arm.

(ii)To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8weeks of treatment for each experimental treatment arm to the SOC arm.

Secondary Objectives

i)To compare time to stable culture conversion by MGIT liquid culture by week 8
for each experimental treatment arm to the SOC arm.

ii)To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for
each experimental treatment arm to the SOC arm.

iii) To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for
each experimental treatment arm to the SOC arm.

iv) To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26
weeks of treatment for each experimental treatment arm to the SOC arm.

v) To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.
vi) To compare a composite of efficacy and safety outcomes using a risk-benefit
approach for each experimental treatment arm to the SOC arm.

vii) To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.

viii) To compare durable cure by 52 weeks after treatment initiation in each
experimental treatment arm to the SOC arm.

 Kampala, Mulago
 Uganda 2024-11-13 18:02:04 2027-11-13 315 participants Participants will be individuals (male and female) with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. Pregnant women will be excluded from the study. US National Institute of Allergy and Infectious Diseases. Medical and Health Sciences Clinical Trial Non-degree Award
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
 Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial
REFNo: HS5151ES

To evaluate the cost-effectiveness of the PPH treatment with HSC compared to PPH treatment with oxytocin, if HSC is proven non-inferior. ,To evaluate the comparative effects of HSC versus oxytocin on haemodynamic outcomes when used for PPH treatment in women receiving HSC for prophylaxis; ,The primary objective of this trial is to evaluate whether HSC is non-inferior to oxytocin for treatment of PPH in women who receive HSC for PPH prophylaxis, in the prevention of additional blood loss of 500 ml or more at 90 min following randomization. ,
 Kampala, Kawempe
 Uganda 2024-11-13 17:36:53 2027-11-13 700 Pregnant women aged 15 years and above UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) Medical and Health Sciences Clinical Trial Non-degree Award
Ezekiel Mupere
ID: UNCST-2024-R003962
 A Randomized Clinical trial: Supplemental choline to prevent and treat learning and memory deficits of early iron deficiency. The SupCHO study
REFNo: HS4915ES

Conduct a randomized, placebo-controlled clinical trial to test whether nine months of daily choline supplementation improves hippocampus-dependent neurobehavioral outcomes in 6-month-old infants with iron deficiency anemia.,
 Kampala, Mulago 1
 Uganda 2024-11-13 16:35:35 2027-11-13 300 The study population will comprise infants aged 6 months (±28 days), recruited from pediatric immunization clinics at Mulago National Referral Hospital and Kawempe National Referral Hospital in Uganda. Participants will include both male and female infants, ensuring a balanced representation of sex in the study. The infants will belong to various tribes within Uganda, reflecting the diverse ethnic composition of the country. However, no specific tribe will be excluded, and the study aims to capture a broad spectrum of ethnic backgrounds to ensure the generalizability of the findings. The inclusion criteria will focus on infants with hemoglobin (Hb) levels between 7.0 g/dL and <11.0 g/dL, who are malaria-negative based on a rapid diagnostic test (RDT), and whose mothers are HIV-negative. Exclusion criteria include infants with developmental disorders, severe malnutrition, known sickle cell disease, neurological disorders, or brain injury. Thrasher Research Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Esther Buregyeya
ID: UNCST-2020-R014116
 Secondary distribution of HIV self-testing by Female Sex Workers, pre-exposure prophylaxis (PrEP) starter packs and brief counseling to promote PrEP initiation and persistence among high-risk men in Uganda
REFNo: HS4891ES

Determine acceptability, feasibility, and safety of the intervention, and preliminary estimates of the potential for the intervention, compared to the control, to promote PrEP initiation, adherence, and persistence among male clients,Conduct an initial (stage 1a) small pilot of the intervention and refine it in preparation for the stage 1b pilot trial,Create the proposed Kayungirizi intervention to promote PrEP initiation and persistence among male clients of FSW through qualitative research informing adaptation and integration of components of local models and aspects of evidence-based interventions,Our overall hypothesis is that secondary distribution of HIVST by FSW to their male clients as an entry point to generate demand for PrEP, followed by an FSW-led intervention to address ongoing structural, interpersonal, and individual-level barriers (convenience, confidentiality/stigma, flexibility) will promote PrEP initiation, adherence, and persistence among male clients. ,
 Kampala, Bwaise
Kampala, Bwaise
 Uganda 2024-10-31 17:21:44 2027-10-31 140 Both male clients of Female Sex Workers (FSW) and the FSW Age 18+ National institute of health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, with or without Tiragolumab, in Patients with Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMBRAVE152)
REFNo: HS5026ES

To evaluate the immune response to tiragolumab and atezolizumab,To characterize the PK profile of atezolizumab plus bevacizumab plus tiragolumab, To evaluate the safety of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab,To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab,
 Kampala, Mulago II
 Uganda 2024-10-14 8:13:47 2027-10-14 10 Patients diagnosed with hepatocellular carcinoma above 18 years of age Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
Wilfred Opobo
ID:
APPROPRIATENESS OF MALARIA CONTROL POLICY AND FACTORS ASSOCIATED WITH PUBLIC COMPLIANCE IN GULU DISTRICT, UGANDA. A QUALITATIVE STUDY
REFNo: SS3130ES

General objective of the study.
• To examine the factors that influence citizens’ compliance with malaria control policy guidelines in Uganda.

Specific objectives of the study.
• To explore how lay perceptions and understandings of malaria control and prevention measures influence citizens’ compliance with malaria control policy.
• To examine the effectiveness of the national information, education, and communication strategies used to promote citizens’ compliance with malaria control policy guidelines.
• To assess the effectiveness of the district malaria governance structures in promoting citizens’ compliance with malaria control policy guidelines.

Gulu, Paduny
 Uganda 2024-10-08 17:44:59 2027-10-08 50 participants initially Target population. The target population for this study encompasses the residents of Gulu district, as well as the governance structures involved in malaria control interventions within the district. Gulu district is predominantly inhabited by the Acholi tribe. However, study participants from the governance structures such as district local government and ministry of Health come from across Uganda. it is also worth mentioning that increasing urbanization is also making the district more cosmopolitan. The study population will be both male and female from the age of 18 years and above. Self sponsorship Social Science and Humanities Clinical Trial Degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SMART (Smallpox vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
REFNo: HS4726ES

Co-Primary objectives Co-primary: 1) To assess the effectiveness of the Smallpox vaccine in preventing RT-PCR confirmed Mpox infection among contacts of confirmed Mpox infection 2) To assess the effectiveness of the Smallpox vaccine in reducing the severity of symptoms; measured as symptom severity score, based on 12 symptom items (16) each assigned a score of 0 to 5 for a total measure of 0 to 60. These co-primary objectives will be evaluated during the first 28 days after randomization.
 Kisoro, Rubanda
 Uganda 2024-09-27 14:06:23 2027-09-27 1560 10 years and above, Males and females, and all tribes residing within the study area that meet the inclusion criteria will be included in the study. McMaster University Medical and Health Sciences Clinical Trial Non-degree Award
EVA NATUKUNDA
ID: UNCST-2020-R014330
 An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
REFNo: HS4706ES

To provide Continued Access to Study Drug to Participants Who Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
Kampala, lubowa
 Uganda 2024-09-25 12:50:13 2027-09-25 86 5 to 18 years Gilead sciences Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 ACTG NEW WORK CONCEPT SHEET (NWCS) 575: Evaluation of biomarkers to predict TB-IRI
REFNo: HS4876ES

1. Determine whether higher levels of a set of biomarkers in people with HIV and tuberculosis prior to ART initiation may predict the development of TB-IRIS, particularly severe IRIS requiring corticosteroid treatment
2. Assess whether these biomarkers decrease between study entry and ART initiation in the deferred arm (i.e. with more prolonged anti-tuberculous therapy duration)
3. Determine whether these biomarkers can be predictive of other severe outcomes especially deaths.

 Uganda 2024-09-11 14:10:40 2027-09-11 1,000 A5221 participants were National Institute of Allergy and Infectious Diseases (NIAIDS) Medical and Health Sciences Clinical Trial Non-degree Award
Achilles Katamba
ID: UNCST-2019-R000540
 Peer-led Implementation of TB-HIV Education and Adherence Counselling in Uganda
REFNo: HS4801ES

To evaluate the implementation fidelity and context of a peer-navigation strategy for TB-EC to improve TB treatment and ART outcomes, To determine the feasibility, acceptability, and appropriateness of a peer-navigation strategy for TB-EC and explore the social-behavioral mechanisms for improving adherence and clinical outcomes. ,To evaluate the implementation of a peer-navigation strategy for TB-EC to improve TB treatment completion and ART retention. , To evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects. ,
 Kampala,
Kampala,
Kampala,
Kampala,
Jinja, Wanyange
Jinja,
Buikwe,
Iganga,
Kiboga,
Mityana,
Butambala,
Wakiso,
Wakiso,
Kayunga,
Kampala,
Kamuli,
Luweero,
Lyantonde,
Mukono,
Uganda 2024-09-10 10:03:57 2027-09-10 1920 index cases Study population in Aim 1: Our target population is adults (age ≥18) starting treatment for TB/TB-HIV in public, private, and private not-for-profit primary care clinics in Uganda. Targeting this population will allow us to assess the impact of the TB-EC on TB and ART treatment adherence and outcomes across a diverse population. Study population Aim 2: For the pilot study to test Aim 2 instruments, we will enroll adults (age ≥18) undergoing evaluation for TB and on TB treatment in primary care clinics. All participants in Aim 1 of the study will participate in the Aim 2 of the study. We administer social and behavioral scales through the surveys that will be conducted in Aim 2. Study population in Aim 3: Aim 3 participants will include a subgroup of individuals enrolled in the Aim 1 trial, their peer navigators, and healthcare workers at study sites. National Institute of health Medical and Health Sciences Clinical Trial Non-degree Award
Milton Musaba Wamboko
ID: UNCST-2019-R000825
 Effectiveness and Safety Dosing of Sodium Bicarbonate in Women with Obstructed Labor in Eastern Uganda: A Phase III Randomized placebo-controlled Trial (SoBicOL- II Study)
REFNo: HS3885ES

General objective
To determine the efficacy and safety of a preoperative infusion of sodium bicarbonate on pH and lactate levels (metabolic acidosis) among women with obstructed labour.
Specific objectives
1. To determine the efficacy of a preoperative infusion of sodium bicarbonate on acidosis, compared with placebo among women with obstructed labour (OL).
2. To determine the safety of a preoperative infusion of sodium bicarbonate compared with placebo among women with obstructed labour (OL).

 Mbale, Kawempe
 Uganda 2024-08-29 18:40:41 2027-08-29 280 Obstructed labour will be diagnosed by either an obstetrician or medical officer using a definition of the American Association of Obstetricians and Gynaecologists (ACOG). In the first stage of labour, the participant should have cervical dilatation >6 cm with ruptured membranes, adequate contractions lasting >4 hours with no change in cervical dilatation or delay in the second active stage of labour (nullipara >2 hours, multipara >1 hour) with adequate uterine contractions. In addition, any two of: the obvious signs of severe obstruction such as caput formation, severe moulding, Bandl’s ring, subconjunctival haemorrhages or an oedematous vulva. Busitema University Medical and Health Sciences Clinical Trial Non-degree Award
GUMA  ASHIRAF
ID:
PREVALENCE, PATTERNS AND CORRELATES OF GENERAL JOINT PAIN AMONG PATIENTS WITH DIABETES MELLITUS ATTENDING DIABETIC CLINIC AT MBARARA REGIONAL REFFERRAL HOSPITAL
REFNo: HS3963ES

To determine the prevalence of general joint pain among patients with DM attending diabetes clinic at MRRH.To determine the patterns of joint pain among patients with DM attending diabetes clinic at MRRH.To determine the associated factors to general joint pain among patients with DM attending diabetes clinic at MRRH.
 Mbarara, Rwebikona
 Uganda 2024-08-29 10:59:36 2027-08-29 242 The study population will be patients with DM attending diabetes clinic at MRRH. The diabetes clinic has a patient census of approximately 1500 patients of which about 80 patients attend every week. The study population is between the age of 18 years to 90 years. Most of the study population are Banyankole, Bakiga and Bahima. The study population is made of both males and females. Guma Ashiraf, Jemba Jovane, Mwesigwa Emma, Bananuka Bernard Medical and Health Sciences Clinical Trial Degree Award
Ruth Namazzi
ID: UNCST-2020-R014305
 Zinc for Infection Prevention in Sickle cell anemia ZIPS-2
REFNo: HS4824ES

The primary objective of the study is to determine if zinc supplementation at 20mg daily is safe and efficacious at reducing all-cause infection in Ugandan children 1.00-4.99 years of age with SCA.Secondary objectives 1. To determine the incidence of adverse events requiring discontinuation of study drug in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 2. To determine the incidence of stroke or death in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 3. To determine the incidence of infections requiring hospitalization in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 4. To determine the incidence of vaso-occlusive crises in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 5. To determine the change in transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 6. To determine change in serum zinc deficiency status from enrollment to 6-month study endpoint in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 7. To determine the incidence of serious adverse events in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 8. To determine the incidence of adverse events in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo
Jinja, Kakindu
 Uganda 2024-08-28 17:29:12 2027-08-28 100 Children with confirmed SCA between 1.00 and 4.99 years of age, living in the malaria endemic area of mid-eastern Uganda, who attend the Nalufenya Sickle Cell Clinic, Jinja Regional Referral Hospital whose caretakers’ consent to study participation CURES WITHIN REACH, INDIANA UNIVERSITY Medical and Health Sciences Clinical Trial Non-degree Award
Herbert Ainamani Elvis
ID: UNCST-2020-R014674
 The Impact of Self Help Plus and Climate Smart Agriculture on Mental Health and Food Security in the Rhino and Nakivale Refugee Settlements of Uganda
REFNo: HS4691ES

To compare the uptake of HGI between the mothers in the combined intervention group (HGI & SH+) with those in the HGI group living in Nakivale refugee settlement,To assess the effect of SH+ on the development of children aged 3-6 years belonging to participating mothers living in Rhino and Nakivale refugee settlements,To assess the effect of SH+ on the mental health of mothers with children aged 3-6 years living in Rhino and Nakivale refugee settlements ,To assess the perceptions and attitudes towards a home gardening intervention (HGI) among participating mothers living in Nakivale refugee settlement,To assess the effectiveness of Self Help Plus (SH+) and home gardening on maternal mental health, food security and child development in the Rhino and Nakivale refugee settlements of Uganda,
 Uganda 2024-08-26 14:58:27 2027-08-26 900 The target population of the proposed research project consists of refugee mothers (age 18+) with children aged 3-6 years, living in the Nakivale and Rhino refugee camps in Uganda. In Nakivale, the study will recruit 900 mother-child dyads across 30 villages, while in Rhino, 720 dyads from 24 villages will participate. Participating mothers in randomly selected intervention villages will be the recipients of the mental health and/or smart farming intervention. Outcomes will be measured at the level of the mother, the child, and the household. Uppsala University Medical and Health Sciences Clinical Trial Non-degree Award
Monicah Agaba
ID: UNCST-2024-R004221
 The Health-Beauty Paradox among Women in Mbarara City Uganda
REFNo: HS4708ES

iii. To characterise the cardio-metabolic profile of WRA.,ii. To document the risk behaviours and their factors related to these societal beauty perceptions.,i. To document societal beauty perceptions and their determinants.,To understand what, why and how the health-beauty paradox is so deeply entrenched in the culture.,
 Mbarara, Sampled
 Uganda 2024-08-26 10:18:37 2027-08-26 300 For the qualitative study, we target both women and men aged 15 up to 65 years who are residents of Mbarara City. For the quantitative study, we target only women of reproductive age (15 to 49 years) who are residents of Mbarara City. For both studies, their ethnicity is not a key inclusion or exclusion criterion. Global Minds Scholarship and Healthy Diets for Africa project Medical and Health Sciences Clinical Trial Degree Award
Rebecca Nuwematsiko
ID: UNCST-2022-R010501
 Effect and implementation factors of a contextually adapted short message service or phone call intervention to reduce loss to follow-up among presumptive TB patients in North Central Uganda
REFNo: HS3000ES

1.To determine the proportion of pre-diagnosis LTFU among presumptive TB patients and influencing factors in North Central Uganda (Sub-study 1). 2.To explore stakeholder’s perceptions on use of an SMS or phone call intervention to reduce LTFU among presumptive TB patients in health care facilities in North Central Uganda and contextually adapt the interventions (Sub-study 2). 3.To assess the effect of a contextually adapted SMS or phone call intervention to reduce LTFU among presumptive TB patients in health care facilities in North Central Uganda (Sub-study 3). 4.To explore factors that influence implementation of a locally adapted SMS or phone call intervention to reduce LTFU among presumptive TB patients in North Central Uganda (Sub-study 3). 5.To synthesize evidence on effectiveness of mHealth interventions to reduce LTFU in the TB presumption phase in LMICs (Sub-study 4)
Mukono, Mukono
Buikwe, Kawolo
Mityana, Mityana
 Uganda 2024-08-22 13:00:28 2027-08-22 1410 This will include presumptive TB patients aged 18 years and above who present to the study facilities during the study period and do not complete diagnosis on the same day of the hospital visit. Inclusion criteria A presumptive TB patient who is;  Aged 18 years and above  Current resident in the study district  Willing to sign informed consent  Owning a personal mobile phone (The patient should be in possession of the phone at the time of screening)  Being able to read  Those sent for GeneXpert testing  Presumed for TB within 12 hours  Patient has not completed TB diagnosis on the same day  Speaks or reads English or Luganda MILEAGE4TB project hosted at Makerere University School of Public Health Medical and Health Sciences Clinical Trial Degree Award
Grace Kisitu Paul
ID: UNCST-2024-R004102
 Universal2: Pharmacokinetics, safety and acceptability of a solid paediatric fixed-dose combination of darunavir/ritonavir (DRV/r) 120/20mg for children living with HIV
REFNo: HS4762ES

To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to Less than 25 kg

To evaluate the acceptability of DRV/r tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To evaluate the short-term efficacy of the DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To describe RTV PK parameters as well as darunavir unbound plasma concentrations.

 Uganda 2024-08-22 11:45:22 2027-08-22 50 Children with HIV, from 3 years of age, requiring DRV/r: • weighing 10 to less than 25 kg with 1 or 2 DRV resistance-associated mutations (RAM) * Or • weighing 10 to less than 20 kg requiring DRV/r, with no DRV RAM* *DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V Fondazione Penta ETS Medical and Health Sciences Clinical Trial Non-degree Award
Agaba Katureebe Ishmael
ID: UNCST-2024-R004089
 Getting a GRIP on Hypertension in Uganda: Giving Repetitive Isometric Exercise for Blood Pressure Control (GRIP in Uganda)
REFNo: HS4712ES

To assess knowledge, attitudes, and practices (KAP) about HTN and experience with IHT (if applicable) ,To measure HTN medication adherence for those prescribed HTN medication during their follow-up, which will be measured through pill counting (counting the remaining amount of pills for prescribed medication).,To assess the need for HTN medication at endline, as per clinical and MOH guidelines, which will be measured through changes in BP levels at week 12,To evaluate the effects of Isometric Hand Training (IHT) on resting diastolic Blood Pressure when compared to standard care after 12 weeks ,To evaluate the effects of Isometric Hand Training (IHT) on resting Systolic Blood Pressure when compared to standard care after 12 weeks ,To determine the efficacy of Isometric Hand Training (IHT) in a population of Hypertension (HTN) patients compared to standard care after 12 weeks of care,
 Jinja, Ivunamba
 Uganda 2024-08-22 11:38:26 2027-08-22 250 adult participants We intend to enroll 250 adult participants men and women aged 18 years and above. Participants will be persons who seek care at the Soft Power Mukagwa Allan Stone community clinic in Kyabirwa jinja. These come from Jinja and the neighboring districts of Iganga, Luuka, Kamuli and Mayuge in East Central sub-region. The area is predominantly inhabited by Basoga and then minority Baganda, Bagisu, Banyole etc. Eligibility criteria Inclusion criteria are: 1) diagnosis of stage 1 HTN (BP >140-159/90-99 mmHg ), which is based on the clinic and MOH definitions , 2) not currently taking HTN medication, 3) not having been on HTN medication in the past 3 months, and 4) age > 18 years and older. Exclusion criteria are: 1) diagnosis of stage 1 HTN and currently taking HTN medication, 2) diagnosis of stage 2 HTN, 3) diabetes, 4) history of recent myocardial infarction (in the past year), 5) congestive heart failure, 6) complete heart block, 7) unstable angina, 8) Glomerular Filtration rate of 90 or lower, 9) any pregnancy associated HTN, 10) any limitation (e.g., limited hand mobility) preventing proper performance of IHT exercise, and 11) any other condition that alters autonomic nervous system function. Canadian Institutes of Health Research (CIHR) Medical and Health Sciences Clinical Trial Non-degree Award
Proscovia Nabunya
ID: UNCST-2019-R000970
 Testing the Feasibility and Acceptability of a Combination Intervention to Address Mental Health among Refugee Youth in Uganda
REFNo: SS2834ES

This proposed two-year study will be conducted in two phases. The first phase seeks to understand whether the COVID-19 pandemic had differential impact on refugee youth living in different settings. The second phase will test the feasibility and acceptability of an innovative combination intervention that has not been previously tested among refugee youth to address psychological problems that have increased since the onset of the COVID-19 pandemic. Aim 1. To examine the mental health impact of COVID-19 on refugee youth living in Bidibidi refugee settlement compared to refugee youth living in urban centers (Arua town) in northern Uganda. Aim 2. To test the feasibility, acceptability and preliminary short-term impact of an innovative intervention combining the youth readiness intervention (YRI) with youth development accounts and financial literacy training (YDA-FLT) to address the mental health impact of COVID-19 among refugee youth living in Bidibidi refugee settlement in northern Uganda.
Uganda 2024-08-19 11:03:04 2027-08-19 200 The total sample size needed for the Refugee Youth COVID-19 study is 200 refugee youth, 15 to 24 years of age. Specifically, we will recruit 100 refugee youth from the five zones within Bidibidi Refugee settlement and another 100 youth among refugee youth living in Arua town (urban center). Youth will be recruited from centrally located ration distribution centers in the settlement, through churches, and youth advocacy groups led by refugee youth in Arua town that we will partner with. For the pilot RCT component, we will only include the 100 participants in Bidibidi refugee settlement with 50 randomized to the treatment group and the other 50 randomized to usual care group. Washington University in St. Louis Social Science and Humanities Clinical Trial Non-degree Award
Peter Olupot-Olupot Olupot
ID: UNCST-2020-R014798
 SMAART-MAP trial Severe Malaria A Research and Trials consortium - Multisite Adaptive Platform trial
REFNo: HS4547ES

OBJECTIVES
The objective of the SMAART-MAP trial is to identify promising adjunctive therapies to take forward into a large Phase III trial in severe malaria with a mortality endpoint. The adaptive platform design enables additional domains to be added so a range of adjunctive therapies can be tested, across multiple clinical presentations of severe malaria, in a timely manner.

PRIMARY OBJECTIVE(S)
To explore within each domain the therapeutic efficacy of the intervention using an early indicator such as a biomarker or clinical assessment at 24-72 hours.

SECONDARY OBJECTIVE(S)
 To assess the impact of the interventions on clinical outcomes (readmission and
mortality) on all children 28 days and 90 days after randomization
 To assess the impact of the interventions on Grade 3 or 4 adverse events, and adverse
events of any grade related to the interventions or comparators.
 To assess the impact of proposed definitions for severe malaria based on platelet counts
≤150,000/µL and plasma pfHRP2 concentrations ≥800 ng/mL on differences between
randomized groups
 In a sub study, to determine the performance characteristics of a POC pfHRP2 test
compared with quantitative plasma pfHRP2 concentrations determined from plasma.

 Mbale, North central
Soroti, Pioneer Ward
Agago, Oreet
 Uganda 2024-08-16 11:01:14 2027-08-16 150 per domain Hospitalized children with severe malaria Imperial College London Medical and Health Sciences Clinical Trial Non-degree Award
VINCENT MUBANGIZI
ID: UNCST-2024-R004232
 Opti-MaP (Optimising Implementation of Maternal and Perinatal Death Surveillance and Response to prevent avoidable future deaths in Uganda
REFNo: HS4630ES

To review existing tools, develop and adapt a harmonised toolbox of resources to optimise MPDSR implementationTo co-design customised an "intervention package" using the toolboxTo evaluate effectiveness and cost-effectiveness of the "customised intervention package" to reduce perinatal and maternal mortalityTo develop and adapt a harmonised toolbox of resources to optimise MPDSR implementation
 Kamwenge, All parishes
Kyenjojo, All parishes
Lyantonde, All parishes
 Uganda 2024-08-06 18:02:24 2027-08-06 For work packages 2-7, the sample size will be determined when the interviewers reach a point of saturation. For the intervention phase (work package 8), the estimated sample size is 4032. Adult males and females plus emancipated minors in the study area regardless of their tribe will be involved in the study. We will also interview key stake holders in the central ministries and bodies. We will interview persons who have lost a women due to pregnancy related causes or had a still birth or a baby died within 28 days of birth Merlin L Willcox Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-Acting Combination Therapy Studies.
REFNo: HS4452ES

The secondary objective is to assess the long-term safety and tolerability of CAB LA + RPV LA by evaluating the incidence of serious adverse events (SAEs), pregnancies, adverse events (AEs) leading to discontinuation of CABLA +RPV LA, and AEs considered to be related to the study intervention.,The primary objective of the study is to provide continued CAB LA + RPV LA access to participants who were enrolled and treated with CAB LA + RPV LA in the parent studies, and who, at the time of roll-over, experience and are expected to continue to experience clinical benefit from this treatment.,
 Wakiso, Katabi
Wakiso, Lubowa
Kampala, Mulago
Kabarole, Buyinga
Uganda 2024-08-06 17:32:50 2027-08-06 710 in Uganda Virologically suppressed adults who have had a detectable HIV viral load in prior 2 years of taking first-line ART or who have disengaged from HIV care. Janssen-Cilag International NV Medical and Health Sciences Clinical Trial Non-degree Award
alfred bulamu
ID: UNCST-2023-R008638
 Uganda Translational Breast Cancer Screening Research Center with Innovations in MRI and Genetic Testing.
REFNo: HS4689ES

Implementation of breast MRI with genetic testing as BC screening method for women at high risk of BC by July 2029 (Phase 6) , Continuous Trainings for radiologists, radiographers and laboratory staffs on the modern technologies of MRI and Genetic testing (phase 3 to phase 6) ,Evaluating the feasibility of screening BC using MRI and genetic testing for high risk women by December 2028 (phase 5),Large scale education of the community about BC by July 2028 (phase 3 and phase 4).,Large scale determination of the utility of genetic testing as a screening modality for BC in Uganda by perform mutational genetic analysis for women at high-risk aged19 years to 80 years by July 2028 (phase 3 and phase 4) , Large scale determination of the utility of quantitative breast MRI for screening women at high risk BC aged 19 years to 80 years by July 2028 (phase 3 and phase 4) ,Training of the users on equipment i.e. Radiologists, Radiographers and laboratory staffs by 2025 (phase 2) ,Securing and installation of lab equipment for genetic testing by 2025 (Phase 2,Securing and installation of MRI with Breast coils by July 2025 (Phase 2),To build capacity for 20 laboratory health care workers in genetic testing technologies by December 2023 (phase 1).,To build capacity for 30 radiology health professionals in modern breast Imaging with MRI by December 2023 (Phase 1),To determine the utility of quantitative breast MRI for screening women at high risk breast cancer aged 19 years to 80 years by July 2024 (phase 1),To determine the utility of genetic testing as a screening modality for BC in Uganda by perform mutational genetic analysis for women at high-risk of BC aged 19 years to 80 years, by July 2024 (phase1),To build a long-lasting infrastructure for research, clinical screening in Uganda and training using modern technologies. ,To offer improved access to Breast Cancer screening in Uganda through quantitative MRI and genetic testing research center,
 All Districts, All parishes
 Uganda 2024-08-06 17:27:31 2027-08-06 100 participants All women at the risk of breast Cancer between the Ge of 19 year to 80years of all the tribes in the different regions Kiphart Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Moses Oketch
ID: UNCST-2024-R004313
 Long-Term Impacts of Improved Childhood Literacy
REFNo: SS2796ES

Economic situation,
 Amolatar,
Dokolo,
UK 2024-08-05 14:01:33 2027-08-05 6581 Former participants of a study on the impact of an early-grade literacy intervention. The study was implemented from 2009 to 2011. The respondents are aged between 19 and 24 years old, with an average age of 21 years. Center for Global Development Social Science and Humanities Clinical Trial Non-degree Award
Jenny Löfgren
ID: UNCST-2024-R005428
 Outcomes of paediatric inguinal hernia repair performed by surgeons versus medical officers
REFNo: HS4508ES

Calculate and compare costs and cost-effectiveness between the two groups. ,Compare patient related outcomes between the group that has been operated on by medical officers versus those who were operated by general surgeons. ,The general objective of the proposed study is to investigate the possibility of task sharing between general surgeons and medical officers in inguinal hernia repair in children in Uganda. ,
 Soroti,
Mubende,
Iganga,
Sweden 2024-07-23 15:30:50 2027-07-23 341 Children, both girls and boys, 1-12 years old. Swedish Research Council Medical and Health Sciences Clinical Trial Degree Award
Nura Izath
ID: UNCST-2022-R009201
 Autothermo-a wearable continuous temperature measuring bracelet with a central display screen.
REFNo: HS3034ES

To assess the performance of Autothermo- a wearable continuous temperature measuring bracelet and a central display screen in comparison to the standard thermometer.,To assess the feasibility and acceptability of Autothermo among health workers and parents/caregivers of admitted neonates at Mbarara Regional Referral Hospital(MRRH).,
 Mbarara, Kamukuzi
 Uganda 2024-07-22 16:57:35 2027-07-22 The sample size of the health workers: Convenient sample of 4 out of 6 health workers engaged in the management and care of newborns admitted at Neonatal Intensive Care Unit-MRRH will be enrolled in the study. These study participants who will be nurses on duty will observe the use of Autothermo, ask a few questions and document findings at the end of each shift. The remaining two nurses will be recruited as study research nurses who will enroll and use Autothermo to monitor temperatures of the admitted newborns during the study period. The sample size for parents or caregivers will be calculated basing on the Kish and Leslie where P (0.5) will be the probability of parents or caregivers who will express willingness to have their newborns’ temperatures monitored with Autothermo and q (1-p) will be the probability of those who will not express willingness to use Autothermo. The study will use a precision of 0.126 and a Z of 1.96 giving a total of 60 parents or caregivers to be recruited into the study. Taking Feasibility and Acceptability of Autothermo: The study will include health workers and parents or primary caregivers of newborn. Parents and caregivers who are 18 years and above will be recruited and all health workers in the Neonatal Intensive Care Unit. The parents or caregivers will be informed that the Autothermo bracelet will be removed at any time at their request. Autothermo Performance Assessment: All neonates (0 to 28 days) admitted to the neonatal unit of MRRH during the study period will be screened for inclusion into the study. Ministry of ICT and National Guidance Medical and Health Sciences Clinical Trial Non-degree Award
Grace Kisitu Paul
ID: UNCST-2024-R004102
 UNIVERSAL1: Pharmacokinetic study of an optimized dose ratio of dolutegravir/emtricitabine/tenofovir alafenamide fumarate: expediting a UNIVERSAL first line regimen for all children living with HIV in Africa
REFNo: HS4280ES

Primary objective:
To evaluate the pharmacokinetics and short-term safety of DTG and FTC/TAF administered to children living with HIV using a novel dose ratio

Secondary objective:
To evaluate the short-term efficacy of DTG and FTC/TAF
formulations in children using a novel dose ratio

 Uganda 2024-07-19 3:45:20 2027-07-19 50 Children aged between 28 days and ≤10 years old weighing ≥3 to <25kg diagnosed with HIV. Fondazione Penta ETS Medical and Health Sciences Clinical Trial Non-degree Award
Janet Nakigudde
ID: UNCST-2019-R000444
 PROMOTING MENTAL HEALTH OF TEACHERS AND CAREGIVERS USING A PERSONALIZED MHEALTH TOOLKIT IN UGANDA
REFNo: HS4431ES

3. To examine feasibility of mWEL-T and mWEL-P with parents and teachers from urban and rural regions (including examining feasibility of the implementation procedures and intervention efficacy) (n=160, 80 parents and 80 teachers from urban and rural regions).,To conduct a user-centered testing study to optimize usability of the Teacher and Parent versions of mWEL- mWEL-T and mWEL-P,1. To build a school system capacity (by establishing a cross-discipline digital health leadership & learning collaborative (n=10) and training a group of peer-community health workers (P-CHW) (n=30; 15 peer teachers and 15 peer parents) to implement the mWEL that is developed,The aim of the study is to test mWEL a newly developed mobile app and user-engagement strategies for mental health management and promotion targeting teachers and parents,
 Kampala, kibuli
Nakaseke, Nakaseke
 Uganda 2024-07-17 14:03:01 2027-07-17 For the proposal sample size N=160 for the full sample The study will enroll parent, teachers and caregivers of children. We shall consider parents who are at least 18 years old, and have a child aged 6-14 years in the enrolled school This study is sponsor by the United States National Institute of Mental Health through a collaboration with New York University, Department of Population Health, New York School of Medicine and Makerere University College of Health Sciences, Department of Psychiatry Medical and Health Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)
REFNo: HS4366ES

Overall Objective
To assess effectiveness and implementation of long-acting cabotegravir (CAB-LA) and oral Truvada (both daily and event driven) through comparison of uptake, retention in care, coital coverage, and participant choice.
Masaka, Masaka
 Uganda 2024-07-02 15:08:06 2027-07-02 400 mobile men. HIV negative men aged 18+ years in South Africa and Uganda. Men who are mobile for work, and in the past 6-months have travelled for work or to find work and spent at least one night away from home for work-related purposes. Men male at birth, able and willing to provide informed consent and willing to have an HIV test. MRC/UVRI &LSHTM Uganda Research Unit Medical and Health Sciences Clinical Trial Non-degree Award
SABRINA KITAKA BAKEERA
ID: UNCST-2020-R014290
 SEARCH2: A Randomized Control Trial of Telephonic Reminders for HPV Vaccination among Adolescent Girls in Kampala, Uganda
REFNo: HS3929ES


General Objective
To conduct a randomized control trial to assess the impact of text message and automated phone reminders on HPV vaccination.

Specific Objectives:
1.To assess the impact of text message and automated phone reminders on HPV vaccination.
Sub-objectives include:
1) To assess if text message and automated phone reminders were equally effective
2) To examine subgroup effects (girl: age, site, school status [in or out of school], grade, relationship with caregiver; caregiver: age, education, employment, income, marital status, distance to health facility, language), when possible depending on the degree of variability observed
3) to assess for possible additive or subtractive effects of receiving two series of message for families of girls who may have been in the intervention for both initiation and completion

Kampala, Adolescent Clinic
Kampala, Kawala HC 3
Kampala, Kiswa HC 3
Kampala, Kisenyi HC 3
 Uganda 2024-07-02 12:45:18 2027-07-02 296 Target population: Families of adolescent girls in Uganda Study population: Families of adolescent girls who visited any of the following health centers: Kisenyi HC IV, Kiswa HC III, or Kawaala HC III or Makerere/Mulago/Columbia Adolescent Health Clinic at Mulago National Referral Hospital Accessible population: Families of adolescent girls who visited any of the following health centers: Kisenyi HC IV, Kiswa HC III, or Kawaala HC III or Makerere/Mulago/Columbia Adolescent Health Clinic at Mulago National Referral Hospital who meet the following selection criteria. National Institutes of Health USA Medical and Health Sciences Clinical Trial Non-degree Award
Elizabeth namukwaya namukwaya
ID: UNCST-2021-R013177
 PARASTOP-Paracetamol with strong opioids
REFNo: HS4423ES

To explore whether placebo with strong opioids compared to paracetamol with strong opioids changes pain intenisty for different doses of opioids, different cancers and quality of lifeintensity,To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid related side-effects,changes in opioid requirements and global rating of improvement,To establish whether placebo with strong opioids compared to paracetamol together with strong opioids provides non-inferior analgesia for cancer related pain,To establish whether the analgesic efficacy of strong opioids after withdrawal of paracetamol is non-inferior compared the analgesic efficacy of strong opioids used together with paracetamol for cancer-related pain.,
 Kampala, Mulago
Kampala, makinndye
 Uganda 2024-07-02 12:41:56 2027-07-02 25 cases and 25 controls Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent. 2. ≥50 kg study dose of paracetamol favours that weight 3. Participants who are under palliative care or oncology service review 4. Diagnosis of metastatic cancer. This includes all incurable solid malignancy in an advanced stage, either locally advanced or metastatic. This also includes malignant lymphoma in the palliative setting and multiple myeloma with bone disease. 5. Clinician-predicted life expectancy >2 months 6. Receiving daily regular strong opioids for cancer pain 7. Receiving stable scheduled opioid dose last 48 hours* 8. Receiving paracetamol 1 gram x three or four times a day for at least five days 9. Average pain intensity past 24 hours ≥ 2 and ≤ 7 (NRS 0-10)* 10. Able to take study drug/placebo as tablets 11. Able to comply with all study procedures 12. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * It is allowed to repeat procedure within the screening period without considering the participant being a rescreen 5.2. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. History of allergy or hypersensitivity to any of the active substances or excipients in the study drug 2. Known severe liver or renal failure equivalent with CTCAE Grade 3 or 4* precluding continuation of paracetamol. (*Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) 3. Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioid therapy 4. Participants receiving systemic anticancer treatment during the intervention period if they are anticipated to have increasing pain or other symptoms related to the treatment 5. Co-enrolment in other drug trials. Participants will not be enrolled in any other on-going interventional clinical trial. Study participants may be enrolled in non-interventional research (e.g. questionnaire, tissue collection studies) 6. Previously enrolled in this study 7. Pregnant or lactating women SouthEastern Norway Regional Health Authority Medical and Health Sciences Clinical Trial Non-degree Award
DAVID KITYA
ID: UNCST-2022-R009620
 Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2500™) in Detecting Intracranial Hemorrhage in Patients Admitted to Mbarara Regional Referral Hospital
REFNo: HS4141ES

Use these findings to evaluate the InfraScanner 2500™\'s ability to accurately detect intracranial hemorrhages in darker-skinned populations within LMICs. ,Determine whether the InfraScanner 2500™ detects intracranial hemorrhage (ICH) with adequate precision relative to CT scans to be used as an effective triage tool to prioritize imaging and need for level of clinical monitoring in an African, LMIC population.,To demonstrate that the InfraScanner 2500™ is capable of detecting and ruling out intracranial hematomas at rates similar to CT scan in patients hospitalized at Mbarara Regional Referral Hospital who have sustained or are suspected to have sustained head trauma.,
 Mbarara, Kamukuzi
 Uganda 2024-06-24 0:30:16 2027-06-24 180 12 years and above Duke Global Neurology Neurosurgery Medical and Health Sciences Clinical Trial Non-degree Award
Hannah Kibuuka
ID: UNCST-2020-R014355
 PROTECT-APT 1 _ Master Protocol for Early Treatment and Post-Exposure Prophylaxis of COVID-19 Adaptive Platform Trial V3.0 dated 02 June 2023 and Appendix C entitled “A phase 2 safety and efficacy study of upamostat for early outpatient treatment of COVID-19” V3.0 dated 01 June, 2023
REFNo: HS3116ES

To determine if early treatment with upamostat can shorten time to sustained symptom alleviation or resolution in participants infected with SARS-CoV-2.
Kabarole, Baza
 Uganda 2024-06-24 0:12:16 2027-06-24 40 Adult male and female participants aged 18 years and above FHI Clinical Medical and Health Sciences Clinical Trial Non-degree Award
Jonathan Izudi
ID: UNCST-2019-R000469
 Integrating Tuberculosis Treatment into Community Pharmacies to improve TB/HIV outcomes in Uganda: the Community Pharmacy Tuberculosis Treatment (COPHAT) study
REFNo: HS4397ES

To evaluate the implementation and preliminary effectiveness of integrating TB treatment into community pharmacies among people with TB/HIV.,To adapt a person-centered strategy for integrating TB treatment into community pharmacies using a human-centered design methodology.,To explore the barriers and facilitators to integrating TB treatment into community pharmacies among people with TB/HIV.,The main objective of this Community Pharmacy Tuberculosis Treatment (COPHAT) study is to develop and pilot an implementation strategy focused on integrating TB treatment into community pharmacies among people with TB/HIV in Kampala, Uganda. ,
 Kampala, Kisugu
Kampala, Kisenyi
Kampala, Kaawala
Kampala, Kitebi
Kampala, Komamboga
Kampala, Kiswa
 Uganda 2024-06-21 17:46:35 2027-06-21 126 People with TB/HIV, ART focal persons, TB focal persons, MoH officials, and Community Pharmacy health workers, aged 18 years and over, irrespective of tribe. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB
REFNo: HS3834ES

1.2 Secondary Objectives 1.2.1 Phase 2a and 2b: To evaluate the proportion of participants with a quantifiable RS ratio after therapeutic vaccination with ID93 + GLA-SE compared to placebo. 1.2.2 Phase 2a: To evaluate the kinetics of cellular immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.3 Phase 2a: To evaluate the kinetics of humoral immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.4 Phase 2a: To evaluate innate immune changes in response to ID93 + GLA-SE through 2 weeks post second dose of study product. 1.2.5 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE, to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, in subgroups defined by: Hard-to-treat phenotype and not hard-to-treat phenotype, where hard-to-treat phenotype is defined as smear Grade ≥3 and cavitary disease on chest radiograph at TB diagnosis.1.3 Exploratory Objectives 1.3.1 Phase 2a: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to: • The safety and immunogenicity of ID93 + GLA-SE in participants living with and without HIV. • The quantitative RS ratio at time points relative to vaccination and TB treatment as indicated in the Schedule of Evaluations (SOE). • The magnitude and quality of immune responses with respect to the composition of the intestinal microbiota. 1.3.2 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, adjusted for • Pharmacokinetics (PK) assessments of first-line TB drugs (exposure) during TB treatment as per the SOE. • Levels of participant adherence to standard of care (SOC) TB treatment measured using self-reporting and urine acetyl-isoniazid (AcINH) from start to end of TB treatment. 1.3.3 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, stratified by bacterial burden at start of TB treatment. 1.3.4 Phase 2a and 2b: To develop the composite predictive model of TB drug response by using measures of adherence, drug exposure (PK), immune response, gut microbiota, and participant phenotype. 1.3.5 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to proportion of participants with sputum culture conversion at baseline at time of randomization and at Step 2, Days 30, 120, and 150, which are approximately 2, 5, and 6 months after start of TB treatment. 1.3.6 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to cumulative relapse from end of TB treatment up to end of study follow-up, that is, Step 2, Days 420, 450, 480, and 510, for Groups 1, 2, 3 (&5), and 4 (&5), respectively. 1.3.7 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to lung function and health-related quality of life, as measured by spirometry and the St. George’s Respiratory Questionnaire. 1.3.8 Phase 2a and 2b: To compare the within-person change in lung function tests over time from the first dose of therapeutic vaccination with ID93 + GLA-SE to placebo. 1.3.9 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to resolution of transcriptomic biomarkers of TB disease. 1.3.10 Phase 2b: To identify correlates of protection for unfavorable TB outcomes. 1.3.11 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes among participants living with and without HIV. 1.3.12 Phase 2a and 2b: To conduct analyses related to furthering the understanding of TB, HIV, immunology, vaccines, and clinical trial conduct.,1.1 Primary Objectives 1.1.1 Phase 2a and 2b: To evaluate safety of a two-dose ID93 + GLA-SE vaccine regimen administered 60 days apart on Step 2, Days 0 and 60, with TB treatment administered, at approximately: 1.1.1.1 Months 4 and 6 after start of TB treatment (Group 1) 1.1.1.2 Months 3 and 5 after start of TB treatment (Group 2) 1.1.1.3 Months 2 and 4 after start of TB treatment (Group 3 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.1.4 Months 1 and 3 after start of TB treatment (Group 4 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.2 Phase 2a and 2b: To determine if therapeutic vaccination with ID93 + GLA-SE will increase the magnitude of vaccine-specific cellular responses compared to placebo at 2 weeks post second dose of study product. 1.1.3 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes (treatment failure, TB recurrence, or death due to TB) at Day 540 after study entry, which is approximately 18 months after start of TB treatment (Group 5 combined with either Group 3 or Group 4, depending on which vaccination schedule is selected for Group 5).,
 Kampala,
Uganda 2024-06-05 17:42:17 2027-06-05 100 Individuals with or without HIV, 18 years or older male or female (any tribe) with bacteriologically confirmed rifampicin-susceptible pulmonary TB receiving locally provided SOC TB treatment. Enrollment of participants living with HIV will be capped at 20% in each group. National Institute of Allergy and Infectious Diseases Medical and Health Sciences Clinical Trial Non-degree Award
ERIC WOBUDEYA
ID: UNCST-2019-R001047
 Shortened RegiMen for Drug-susceptIbLE TB in Children
REFNo: HS4030ES

Primary
1. To determine if an 8-week HPZM regimen in children with presumed drug-susceptible TB disease has non-inferior efficacy to 8-weeks of HRZ(E) plus 8- or 16-weeks of HR(E) for achieving treatment success.
2. To evaluate the safety of the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
Secondary
1. To evaluate the tolerability of the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
2. To determine the weight-banded dosing of rifapentine and moxifloxacin taken as part of the HPZM regimen.
3. To evaluate the palatability and acceptability of the 8-week HPZM regimen in comparison to the 16- or 24-week HRZ(E) regimen among children with and without HIV.
4. To evaluate adherence to the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
5. To evaluate clinical and laboratory characteristics and drug exposures associated with unsuccessful treatment outcomes (treatment failure or death).
6. To evaluate the cost and cost-effectiveness of the 8-week HPZM regimen relative to the 16- or 24-week HRZ(E) standard of care regimen, using a societal approach.
Exploratory
1. To characterize rifapentine and moxifloxacin PK parameters in malnourished children.
2. To evaluate the effect of rifapentine or rifampin, taken as part of the HPZM or HRZ(E) regimen, on the PK of dolutegravir.
3. To evaluate virologic control (less than 200 copies/mL) at 24- and 48-weeks among children with HIV taking a dolutegravir-based ARV treatment regimen co-administered with either HPZM or HRZ(E).
4. To collect and store biospecimens from consented participants for the purpose of future TB research.

 Kampala, mulago
 Uganda 2024-05-31 18:02:19 2027-05-31 150 Children less than 10 years of age Johns Hopkins University Medical and Health Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an Extension phase with repeated KLU156 treatment.
REFNo: HS3732ES

This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P.Falciparum malaria (with or without other plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure(ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.
 Tororo, Tororo
 Uganda 2024-05-29 9:37:35 2027-05-29 1500 male and female patients’ ≥ 5 kg body weight and ≥ 2 months of age will be randomized in the study Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Jane Achan Edwin
ID: UNCST-2023-R005498
 Evaluation of the protective efficacy of a spatial repellent to reduce malaria prevalence in Uganda: Study protocol for a cluster-randomized double-blinded control trial: The Mossie-GO trial
REFNo: HS4196ES

The study’s primary objective is to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria infection in children ≤ 5 years of age.

The study’s secondary objective is to measure the impact of the intervention on entomological correlates of transmission including vector densities and host seeking behaviour. Insecticide resistance in the local mosquito population will also be explored.

Buikwe, N/A
Jinja, N/A
 Uganda 2024-05-23 14:23:11 2027-05-23 5600 The population will include children less than 5 years of age living in selected households in the selected villages. We will include children of both sexes and of all tribes in the selected villages. AFRICA POWER Medical and Health Sciences Clinical Trial Non-degree Award
Josephine Najjuma Nambi
ID: UNCST-2021-R013717
 Developing and testing a simulation-based intervention to improve stroke nursing care in Mbarara Regional Referral Hospital
REFNo: HS3535ES

6. Pilot test the simulation-based nursing intervention for feasibility, acceptability, functionality, quality of life, and preliminary health outcomes among stroke patients at MRRH. ,5. Develop a simulation-based stroke training packet/intervention for nurses to improve stroke care and management at Mbarara Regional Referral Hospital,4. Explore the barriers and facilitators for stroke management, and training among health care professionals at Mbarara Regional Referral Hospital ,The general objective of the study is to develop and pilot a simulation-based stroke intervention to improve stroke management at MRRH ,
 Mbarara, Kyamugorani
 Uganda 2024-05-07 13:49:58 2027-05-07 168 Age 18-100, Both male and Female and all tribes Self-sponsored Medical and Health Sciences Clinical Trial Degree Award
Jenny Löfgren
ID: UNCST-2024-R005428
 Simulation-based training for mesh inguinal hernia repair under local anaesthesia - a randomized trial
REFNo: HS4058ES

Assess the learning curve of mesh inguinal hernia repair for novice learners and how it is affected by simulation based training prior to supervised surgery on patients.
Soroti,
Mubende,
Iganga,
Sweden 2024-05-02 12:38:06 2027-05-02 440 Trainees: intern doctors with an interest in surgery and who are not already routinely performing inguinal hernia mesh repair Patients: Adult (18 years and above), otherwise healthy (ASA 1-2) men with primary, reducible, groin hernia Karolinska Institutet Medical and Health Sciences Clinical Trial Degree Award
Christopher Turyatunga Bernard
ID: UNCST-2023-R006842
 Drivers, profiling and drugs resistance effects, outcomes and cost-effectiveness of diagnostic and Syndromic interventions among urogenital discharging patients in southwestern Uganda
REFNo: HS3796ES

Establish the aetiology and sensitivity profile of urogenital discharges among patients in south western Uganda. ,5. Evaluate the Comparative cost effectiveness of diagnostic and Syndromic approaches in the management of patients with urogenital discharges in south western Uganda.,4. Compare the treatment outcomes between syndromic and diagnostic approaches in the management of patients with urogenital discharges in south western Uganda.,3. Determine the drivers of drugs resistance among patients with urogenital discharges in south western Uganda. ,2. Determine the effect of drugs’ resistance on the management of patients with urogenital discharges in south western Uganda.,This study is aimed at establishing the drivers, profiling and effect of drugs resistance, comparative treatment outcomes and cost-effectiveness of diagnostic and Syndromic interventions on patients with urogenital discharges in southwestern Uganda, and it is a parallel randomized intervention at STI clinics of Kabale and Mbarara Regional Referral Hospitals and Kisiizi Mission Hospital.,
 Uganda 2024-04-26 9:21:22 2027-04-26 476 Females and males Participants aged 15 to 60 years, with urethral and abnormal vaginal discharges void of HIV/AIDS, Diabetes Mellitus and pregnancy who have sought treatment more than once in the previous three months. MUST and STUDY Participants Medical and Health Sciences Clinical Trial Degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 Bridges2Scale: Testing Implementation Strategies for an intervention among young people affected by AIDS
REFNo: SS2488ES

Bridges2Scale will use a two-arm Hybrid III effectiveness-implementation cluster randomized clinical trial, where we will compare two multifaceted strategies (standard vs. enhanced) for scaling the Bridges interventions (consisting of financial literacy training, peer mentorship, family income-generating , and youth development accounts). The standard implementation strategy has been applied in our prior and ongoing studies and involves educational meetings that prepare staff members to deliver Bridges with minimal disruption to site workflow. This will be compared to an enhanced strategy that will be developed using Implementation Mapping, a systematic protocol for developing implementation strategies using theory, evidence, and stakeholder input. Aim 1: Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. Aim 2: Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4: Compare the cost and cost-effectiveness of the two implementation strategies.
 Masaka, Kimaanya
Rakai, Kakuuto
Kyotera, Kyotera TC
Lwengo, Lwengo
Kalungu, Kasaali
Sembabule, Parish ward
Bukomansimbi, Mbiriizi
 Uganda 2024-04-19 18:42:54 2027-04-19 1440 Inclusion and Exclusion Criteria: Adolescent Inclusion Criteria: (1) ages 13-17 years; (2) a student at one of the 48 public primary schools included in the study; (3) living within a family and not an institution/orphanage. Caregiver Inclusion Criteria: A caregiver would be eligible if they are (1) self-identified and confirmed by the AY as primary caregiver of the AY; and (2) capable of providing informed consent. Schools’ inclusion criteria: The 48 public (government) primary schools would be eligible if they are (1) located in one of the seven districts in the greater Masaka region – on secondment from the Ministry of Education or local government representative (District Education Officer [DEO]), and (2) willing and able to participate in study implementation. Youth-serving NGOs will be invited if they are: (1) registered with the government of Uganda; (2) willing to work with the study team; and (3) have a history of implementing micro-finance EE interventions. Exclusion criteria: Adolescents will be ineligible if: 1) they are unable to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent and parent. 2) If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation. Facilitator Recruitment. The leaders of public schools and youth-serving NGOs will help us select the facilitators based on their interest in the intervention and willingness to work with study participants. Standard Implementation Strategy (SIS) condition. we will meet with both NGO and school staff to gauge their interest in partnering on study implementation and describe roles and responsibilities. Enhanced Implementation Strategy (EIS) condition. The headmaster of each school in the EIS will identify at least 2 teachers per school to be enrolled in the study and deliver the intervention—as implementation champions. We expect to recruit at least 48 teachers in EIS (2 teachers/school x 24 schools). Similar procedures will be followed for NGO staff. Specifically, we will recruit at least 8 facilitators from NGOs and 8 facilitators from community (including PTA members) to serve as trainers for implementation champions. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Social Science and Humanities Clinical Trial Non-degree Award
Patricia NAHIRYA Ntege Nahirya
ID: UNCST-2019-R001117
 Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition.
REFNo: HS3876ES

Primary Objective
• To describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 084 studies and their associated sub-studies.

Secondary Objective
• To describe any serious adverse events (SAEs), Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal in adult and adolescent participants included in the HPTN 084 studies and their associated sub-studies.


 Kampala, Mulago
 Uganda 2024-04-04 8:20:33 2027-04-04 146 Participants must be currently enrolled and ongoing in one of the following studies: • HPTN 083 • HPTN 084 • HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study. 2. Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study. 3. Participants must have a nonreactive HIV test at Screening (rapid test, antigen/antibody test and HIV-1 RNA from the parent study/sub-study) and Day 1 (a rapid test and HIV Immunoassay [Antigen/Antibody test]) Males and Females: All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs. Females: Cisgender female participants who are of childbearing potential and who are engaging in sexual activity that could lead to pregnancy, must talk to the investigator about recommended contraception options (Section 11.1). Contraception will be optional in this study. Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. Pregnant participants from the HPTN 084 study are eligible to enroll into this study f they meet all eligibility criteria ViiV Healthcare UK Limited Medical and Health Sciences Clinical Trial Non-degree Award
KANIKA  Jean-Claude MASSAMBA
ID:
effectiveness of vaginal misoprostol versus vaginal dinoprostone among pregnant women undergoing labor induction at Jinja regional Referral Hospital. (REC Approval: BSU-REC-2023-244)
REFNo: HS4007ES

To assess the Peripartum fetal complications as well as the maternal obstetrics outcomes in vaginal misoprostol group versus vaginal dinoprostone group at Jinja Referral Regional Teaching-Hospital maternity ward. ,The main goal of this study is to compare the effectiveness of vaginal misoprostol to vaginal dinoprostone and identify the feto-maternal complications in women undergoing labor induction at Jinja Referral Regional Teaching-maternity Hospital\'s unit.,
 Jinja, Jinja
 Democratic Republic of Congo 2024-03-28 18:36:47 2027-03-28 136 Pregnant women between 37 weeks + 0 day to 41 weeks + 6 days of gestation attending antenatal clinic at Jinja RRH and who have indications of labor induction and consent to participate in the study. Principal Investigator Medical and Health Sciences Clinical Trial Degree Award
Jonathan Izudi
ID: UNCST-2019-R000469
 Effectiveness of Multi-Month Dispensing of Anti-Tuberculosis Drugs (MULTI-DAT) Versus Standard of Care on Treatment Success Rate Among People with Drug Susceptible Tuberculosis in Rural Eastern Uganda
REFNo: HS3953ES

To evaluate the effectiveness of MULTI-DAT on cure and treatment success rates at 6 months of treatment compared to the standard of care (SOC) using an open-label, individually randomized controlled trial or RCT (Aim 2). ,To explore stakeholder perceptions regarding the relevance and appropriateness of MULTI-DAT, including the delivery of MULTI-DAT among people with drug-susceptible PTB aged ≥15 years using a qualitative study (Aim 1).,Overall, the MORAD study will focus on the practicability and effectiveness of MULTI-DAT among people with drug-susceptible pulmonary TB (PTB) aged ≥15 years on the standard 6-month anti-TB treatment regimen in eastern Uganda,
 Soroti, Soroti
Kumi, Kumi
Serere, Serere
Not Applicable (N/A), Soroti
 Uganda 2024-03-27 18:52:57 2027-03-27 66 stakeholders (Aim 1); 260 participants in a 1:1 ratio (Aim 2) Aim 1: i) TB focal persons with ≥1 year of work experience; other stakeholders with ≥3 years of work experience in TB; ii) People with TB on treatment for ≥4 months including the respective treatment supporters. Aim 2: People with drug-susceptible PTB ≥15 years. UC Berkeley Medical and Health Sciences Clinical Trial Non-degree Award
Ahmed Ddungu
ID: UNCST-2019-R000944
 CHARACTERIZATION OF TUBERCULOSIS ASSOCIATED LUNG FIBROSIS AND RESPIRATORY IMPAIRMENT, AND PREVENTION USING DOXYCYCLINE IN A DOUBLE BLIND RANDOMISED CONTROLLED TRIAL
REFNo: HS3385ES

To characterise/describe TB associated lung fibrosis and TB associated chronic respiratory impairment (where appropriate: burden and severity, radiological phenotype based on high resolution CT, clinical phenotype based on symptoms and lung function status, and predictors/ associations (including with selected biomarkers)); and to assess the efficacy of doxycycline as an adjuvant therapy to prevent TALF amongst patients with advanced TB
 Kampala, Mulago
 Uganda 2024-03-20 15:59:56 2027-03-20 0200 - Age of 18 – 65 years - sex : Male and Female - Tribe (Non discriminatory of tribe) - Index PTB episode (sputum smear positive or GeneXpert positive with rifampicin susceptibility) - Baseline Chest X-ray showing infiltrates in at least 2 lung zones (≥30% lung involvement) meeting criteria for moderate/advanced PTB - HIV uninfected (clinical trial ) - Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. - Able to give written informed consent. Makerere University Research and innovation Fund and Makerere University Lung Institute through the MAKNCD PROGRAM Medical and Health Sciences Clinical Trial Degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Performance Evaluation of the TrinScreen™ HIV rapid test kit
REFNo: HS3878ES

1. To describe the performance (sensitivity and specificity) of the TrinScreen™ rapid test, when compared to the national testing algorithm.

2. To describe the performance (sensitivity and specificity) of the TrinScreen™ rapid test compared to the reference testing (Genscreen ULTRA HIV1/2 Ag/Ab EIA followed by the Murex diasorin HIV1/2 Ag/Ab combination).


3. Estimate the proportion of inconclusive test results by Trinscreen™

Kampala, Naguru
Wakiso, kigongo
Gomba, mpigi
Kayunga, Kawolo
Mukono, Mukono
Mpigi, Nkozi
Wakiso, Mityana
Wakiso, wagagai
Kayunga, Kayunga
 Uganda 2024-03-14 12:38:09 2027-03-14 1550 - Adults above 18 years of age - Willing to have an HIV test. - Eligible for testing as per the National HIV testing service eligibility screening tool - Documented co Trinity Biotech Manufacturing Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Kamoga Ronald
ID: UNCST-2019-R001524
 VAGUS NERVE STIMULATION IN A RAT MODEL OF ALZHEIMER’S DISEASE-LIKE SYMPTOMS: MORPHOLOGICAL, IMMUNOHISTOCHEMICAL, MOLECULAR AND BEHAVIORAL CHANGES
REFNo: HS3781ES

1. To conduct a scoping review of literature on vagus nerve stimulation in Alzheimer's-disease and related dementias.
2. To determine behavioral changes associated with vagus nerve stimulation in a rat model of Alzheimer-like symptoms.
3. To evaluate the morphological, Immunohistochemical and molecular changes in the Hippocampus, prefrontal cortex and medial temporal cortex associated with chronic stimulation of the vagus nerve in a rat model of Alzheimer’s-like disease.

 Mbarara, Medical cell
 Uganda 2024-02-26 13:43:22 2027-02-26 42 Wistar rats Wistar rats bewteen 3 months and 7 months old Self sponsorship Medical and Health Sciences Clinical Trial Degree Award
Sarah Lofgren
ID: UNCST-2019-R001647
 Supervised Treadmill intervention to Reduce Inflammation and Depression through Exercise in HIV: The STRIDE Pilot Study
REFNo: HS3358ES

The objective of this study is to determine the feasibility and acceptability of an aerobic intervention via a treadmill among individuals with HIV and depression in Uganda.
3.1 Primary Endpoint: Feasibility and acceptability of Exercise as a treatment for depression in Ugandans with HIV. This will be measured by:
-Percent completion of the prescribed aerobic exercise intervention, as assessed by research staff logging participation.

3.2 Secondary Endpoint(s)/ Outcome(s):
- acceptability of the intervention assessed via a post intervention survey
-feasibility and acceptability of using a wearable exercise tracker to assess the volume of exercise, based on calories burned and steps achieved, during the intervention period among Ugandans with HIV and depression.
- measure the mean and standard deviation of baseline and 8-week serum BDNF and IL-6 level to estimate an effect size and power a future study.
- measure the mean and standard deviation of baseline and 8-week depression score via PHQ-9 to estimate an effect size and power a future study.
- measure the mean and standard deviation in aerobic fitness baseline and at 8 weeks measured via METS/watts achieved and total time/distance to estimate the effect size for a future intervention.
Wakiso, Lweeza
 USA 2024-02-26 13:41:23 2027-02-26 24 • Enrolled in Mildmay HIV clinic • Adults 18-45 years old • HIV positive • Receiving HIV therapy • HIV viral suppression (<400 copies/mL) per chart review • Mild to Moderate (PHQ9 score >5 but >20) • Not currently engaged in a formal exercise program or manual labor such as construction or delivery requiring a manual bike or walking • Able to walk/run on a treadmill • Informed consent University of Minnesota, Makerere University Medical and Health Sciences Clinical Trial Non-degree Award
Julian Adong
ID: UNCST-2021-R013487
 Retention through mHealth for adolescents and young adults with HIV in care
REFNo: HS3722ES

Test the acceptability, feasibility, and preliminary impact of the developed adolescent-tailored mHealth intervention for retention in care of AYWH who are new to or newly re-engaging in care,Iteratively develop a social media-based adolescent-tailored mHealth intervention to improve retention in care for AYWH who are new or newly re-engaging in care,Define the cognitive, environmental, and behavioural challenges and their impact on behavioural intention for AYWH who are new or newly re-engaging in HIV care,To develop and test an mHealth intervention for retention in care for adolescents and young adults with HIV,
 Mbarara, kamukuzi
Mbarara, kamukuzi
 Uganda 2024-02-26 13:34:00 2027-02-26 105 We will enroll male and female adolescents and young adult participants with HIV aged 15-24. and health care workers aged 18 and above. National Institutes of Health/Fogarty International Center Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SOLIDARITY TRIAL-A phase I/II Randomized Placebo controlled trial to evaluate the Safety and Immunogenicity of Sudan Ebolavirus in Uganda
REFNo: HS3190ES

Phase I (rVSV-SUDV)
1. To determine the safety of rVSV-SUDV candidate SUDV vaccine among adult healthy volunteers in Uganda.
2. To determine the immunogenicity of rVSV-SUDV candidate SUDV vaccine.

Phase II (ChAdox1, CAd3 and rVSV-SUDV)
Primary objectives
1. To determine the safety of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccines among healthy volunteers and persons with stable comorbidities.
2. To determine the immunogenicity of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccines.
Secondary objectives
1. To determine the durability of SUDV-specific induced immune responses following vaccination.
2. To determine the factors associated with optimal vaccine-induced immune responses.
3. To determine the putative cross reactivity by the SUDV vaccine candidates against other ebolaviruses (e.g. Bundibugyo ebolavirus (BUDV) and EBOV).

Exploratory objectives
1. To determine the effect of SUDV vaccines on host gene expression.
2. To determine the T and B cell specific responses and immune profiling in response to vaccination.
3. To determine the effect of SUDV vaccines on the host metabolome.
4. To determine the effect of SUDV vaccines on host innate immune responses.

 Kabarole, Fort portal
Kampala, Mulago I
Kayunga, Kayunga
Mbarara, Rubindi
Wakiso, Nkumba
Mubende, Kikanddwa
Masaka, Kabonera
 Uganda 2024-02-26 13:31:25 2027-02-26 2121 participants will be recruited in phase II and phase I will recruit 250 participants healthy volunteers both male and females will be recruited in the study regardless of the ethnic group they belong to. The participants will recruit people aged 6-65 in to phase I and phase to World Health Organization and Ministry of Health Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Betty Mwesigwa
ID: UNCST-2020-R014667
 Sabin 003: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
REFNo: HS3628ES

To evaluate the safety and tolerability of cAd3-EBO S vaccine
 Kampala, Central
Kampala, Central
Kampala, Central
 Uganda 2024-02-13 17:35:43 2027-02-13 125 participants 18 to 70-year old healthy adults Sabin Vaccine Institute Medical and Health Sciences Clinical Trial Non-degree Award
Juliet Babirye Ndimwibo
ID:
TREAT INTERACT: Implementing a user involved education- and health system interactive task-shifting approach for child mental health promotion in Uganda
REFNo: HS3144ES

Based on findings from objectives 1-2, develop implementation advice to guide policymakers in school-based child and adolescent mental health (CAMH) management, integration with the health system, and how to implement and sustain large-scale evidence-informed CAMH interventions to contribute towards achieving universal mental health coverage. ,Develop, implement and evaluate an intersectoral supervision, referral and communication model between the health and education sector.,Implement the adapted module-based TREATment mhGAP school program and investigate effective implementation strategies and client outcomes.,Intervention mapping to adapt the mhGAP-IG to a primary school setting, and implementation mapping to develop implementation strategies with user involvement,The main objective of the TREAT INTERACT study is to adapt, implement and evaluate the impact of an adapted school version of the mhGAP-IG that aims to prevent, identify, refer and treat mental health problems in children and adolescents in Uganda through a user involved task-shifting implementation of the mhGAP-IG among primary school staff. This work is divided into 4 work Packages (WPs); each of the specific objectives below represents a single work package.,
 Mbale, Primary schools
 Uganda 2024-02-02 12:05:35 2027-02-02 612 teachers Teachers and pupils at primary schools Norwegian research Council Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Ajilong
ID: UNCST-2022-R005889
 Assessing Vitamin D serum levels in HIV-positive adolescents 10-19 years with depression in Northern Uganda
REFNo: HS3454ES

To determine the burden of depression in HIV-positive adolescents at Gulu RRH,To assess for serum Vitamin D levels in HIV Positive adolescents 10-19 years with depressive symptoms in Gulu Regional Referral Hospital Methods,
 Gulu, Laroo
 Uganda 2024-01-24 22:30:43 2027-01-24 380 participants HIV Positive adolescents at Gulu Regional Referral Hospital Child Global Research Fellowship Medical and Health Sciences Clinical Trial Non-degree Award
Zubair Lukyamuzi
ID: UNCST-2021-R013107
 Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial
REFNo: HS3430ES

1. To compare completion of self-initiated HIV testing between intervention and control groups
2. To evaluate the preliminary effectiveness of the intervention on change in behaviors associated with HIV acquisition
3. To compare interest in or use of HIV prevention services between intervention and control groups
4. To evaluate the preliminary effectiveness of the intervention on incident STIs
Kalangala, Bugala Island
 Uganda 2024-01-08 13:20:21 2027-01-08 up 250 the study population will be men aged at least 16 at risk of HIV in Kalangala Division of AIDS (DAIDS), United States (US) National Institute of Allergy and Infectious Diseases (NIAID), US National Institutes of Health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
Timothy  Muwonge Ronald
ID: UNCST-2020-R014680
 Achieving HIV viral suppression in refugee settlements in Uganda with Head StART: a cluster randomized trial evaluating the effectiveness of community ART delivery for people newly diagnosed with HIV
REFNo: HS2935ES

To estimate the programmatic cost and budget impact of implementing the Head StART intervention in refugee settlements in Uganda. ,To assess Head StART implementation across refugee settlement sites to understand the impact of contextual factors on study outcomes. ,To evaluate the effectiveness of “Head StART,” the expansion of community ART delivery to people newly diagnosed with HIV, in achieving HIV viral suppression in refugee settlements in Uganda. ,The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.,
 Uganda 2024-01-05 9:11:58 2027-01-05 1200 We will recruit adult persons living with HIV aged 18 and above and accessing care from health care centers in refugee camps in Uganda. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
PATRICK MUSINGUZI
ID: UNCST-2023-R007731
 UTILITY, ACCEPTABILITY AND APPLICABILITY OF A NUCLEIC ACID AMPLIFICATION TEST (NAAT) IN COMPARISON WITH SYNDROMIC APPROACH IN THE MANAGEMENT OF SEXUALLY TRANSMITTED DISEASES AT MULAGO NATIONAL REFERRAL HOSPITAL IN UGANDA.
REFNo: HS3100ES

To estimate the actual relative prevalence of causative agents of STDs in our study setting.,To evaluate the acceptability of the NAAT.,To assess the degree of concordance between actual pathogens diagnosed through the molecular test and the presumed pathogens indicated by the syndromic approach.,To evaluate whether the use of NAAT for the management of STDs improves clinical outcome and microbiological cure compared with the syndromic approach.,To evaluate whether microbiological diagnosis using NAAT improves appropriateness of therapy of STDs (as a measure of clinical usefulness) in comparison with the syndromic approach without or with limited laboratory tests currently in use.,
 Uganda 2024-01-05 9:01:56 2027-01-05 240 Adults aged 18 years and above presenting with signs and symptoms of STDs at the Mulago Hospital STDs clinic during the study period, who provide written consent to the participation to the study and are diagnosed with UDS, AVD and GUD. Italian Society of Infectious and Tropical Diseases (SIMIT) Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
 Six weeks of daily Rifapentine vs. a comparator arm of 12-16 week Rifamycin-based treatment of latent M. tuberculosis infection: Assessment of safety, tolerability, and effectiveness
REFNo: HS3492ES

The main objective of this trial is to compare the safety and effectiveness of a six-week regimen of daily Rifapentine to that of a standard arm of 12weeks of HP or 12 weeks of H or 16 weeks of R for the treatment of LTBI
 Kampala, Mulago
 Uganda 2023-12-21 20:31:51 2026-12-21 The target total enrollment is 3400 participants from all participating sites and approximately 250 participants will be enrolled from the Ugandan site The target study population will include male and female (except pregnant or breast-feeding) participants aged 12 years or older with LTBI who do not have evidence of active disease and are at increased risk of progression to active TB. U.S. Centers for Disease Control and Prevention Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Ssesanga Ernest
ID: UNCST-2023-R008022
 EFFECT OF MHEALTH COMMUNICATION ON STIGMA AND RETENTION IN CARE AMONG YOUTH LIVING WITH HIV AND LINKED TO CARE IN UGANDA.
REFNo: SS2215ES

1. To explore the effect of mhealth communication on stigma among youth living with HIV and linked to care in Uganda.
2. To systematically develop and evaluate an mHealth intervention on stigma and retention in care among youth living with HIV and linked to care in Uganda.
3. To investigate the determinants of stigma and retention in care among youth living with HIV and linked to care in Uganda.
4. To determine the effect of mhealth communication on retention in care among youth living with HIV and linked to care in Uganda.
 Kampala, Nsambya
Kampala, Mulago
Jinja,
Jinja,
Uganda 2023-12-19 11:26:33 2026-12-19 142 Participants will include voluntary consented and assented HIV-positive patients aged 15-24 years, who communicate in English, Lusoga or Luganda. Clinical Uganda Virus Research Institute Social Science and Humanities Clinical Trial Degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 Platform Assessing Regimens And Durations In a Global Multisite consortium for TB. A Seamless Phase 2B/2C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis
REFNo: HS3044ES

Phase 2C: Amongst regimens selected for progression from phase 2B, to further evaluate the safety profile and to identify the optimal treatment duration (between 8 and 16 weeks) based on unfavourable outcome to support advancement to future Phase 3 trials.,Phase 2B: To identify regimens with acceptable safety profile that have the greatest potential, based on assessment of quantitative sputum liquid culture and treatment failure/relapse to progress to investigation of optimal treatment duration in Phase 2C.,To identify novel drug regimen(s) with acceptable safety profile, non-inferior efficacy and shortened treatment duration compared to the standard-of-care 24-week HRZE regimen that could be used to treat people with rifampicin susceptible and rifampicin resistant TB.,
 Kampala, Kampala
Wakiso, Kampala
Mukono, Kampala
Mpigi, Mpigi
 Uganda 2023-12-01 17:56:07 2026-12-01 Up to 2500 overall will be enrolled, 700 in phase 2B and 1800 in phase 2C. An estimate of 165 patients in total for Uganda sites (60 in phase 2B and 105 in phase 2C) and about 30 patients for JCRC Lubowa in phase 2B and 55 patients in phase 2C. Adults ≥18 years with newly diagnosed pulmonary TB will be enrolled University College London Medical and Health Sciences Clinical Trial Non-degree Award
Jude Byansi Zziwa
ID:
DEVELOPING A FRAMEWORK FOR PROVIDING SUSTAINABLE SANITATION SERVICES IN URBAN SCHOOLS IN LOW- AND MIDDLE-INCOME COUNTRIES: A CASE OF TWO CITIES IN UGANDA
REFNo: SIR254ES

(iv) To establish the effect of the school centered sanitation service framework on human faecal exposure pathways in urban schools of LMICs.,To ascertain how the key factors in objective (ii) above, interact to provide sustainable sanitation services in city schools,To establish factors sustaining sanitation service provision in city schools,To determine the status of sanitation service provision in city schools ,The general objective of this study is to develop a sanitation management framework that will contribute to sustainable service provision in urban schools of Low- and Middle Income Countries (LMICs).,
 Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
 Uganda 2023-11-20 15:27:51 2026-11-20 2,434 participants The pupil population from age 9 to 25 years, Teacher population from age 23 to 60 years, Other stakeholders will be adults. Male and female participants will be balanced. Citywide Inclusive sanitation Program Engineering and Technology Clinical Trial Degree Award
sunday anziku oyeeson
ID:
Exploring the Teachers’ Feedback Practices and its Influence on Students’ Learning in CBC: A case of a selected secondary school in Central Division, Arua City.
REFNo: SS2007ES

To explore how teachers’ feedback influences students' learning in CBC in lower secondary schools in Arua City.
To find out how students perceive the influence of feedback on their own learning in CBC.
To examine the strategies used by teachers to administer feedback to students in CBC in lower secondary schools in Arua City.
To find out the challenges faced by teachers in administering feedback to students in CBC in lower secondary schools in Arua City.

 Uganda 2023-11-16 13:34:21 2026-11-16 2 school administrators (Headteacher and Deputy), 3 Teachers of lower secondary or CBC classes (S.1, S.2, and S.3) and 9 Students in CBC classes (considering 3 students from each class) The study will be conducted in a secondary school involving CBC class students, teachers and the school administrators Self-Sponsored Social Science and Humanities Clinical Trial Degree Award
Esther Atukunda Cathyln
ID: UNCST-2019-R001701
 Integration of a patient-centered mobile health intervention (Support-Moms) into routine antenatal care to improve maternal health in Uganda.
REFNo: HS3366ES

Evaluate the cost and cost-effectiveness of implementing Support-Moms intervention into routine care and implications for sustainability,Evaluate intervention implementation using the Proctor framework and plan for future scale-up per the Consolidated Framework for Implementation Research ,Test the effectiveness of the Support-Moms intervention in a randomized controlled trial,
 Uganda 2023-11-13 12:57:49 2026-11-13 824 We will include individuals who: 1) are in the first trimester of pregnancy who have not yet presented for ANC, 2) reside in the catchment area of a study HC, 3) are emancipated minors and adults aged ≥ 18 years, 4) report access to a cell phone with reception in their home, 5) are able to identify at least two social supporters living within the study districts, and 6) are able to provide consent. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
 A phase II/III, open-label, randomized clinical trial to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
REFNo: HS3240ES

To assess the time to insert the REBOA.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy is lower in the intervention arm when excluding ‘inevitable’ hysterectomies due to either an irreparable uterine rupture, a pathological placenta growing into the uterus (placenta accreta, increta or percreta) or a pathological uterus, such as a bicorne uterus or one with very large fibroids.,To assess if post-partum haemoglobin concentration is higher in in the intervention arm compared to the comparator arm,To assess if the number of blood transfusion units is lower in the intervention arm compared to the comparator arm.,To assess if the number of participants with acute kidney injury is lower in the intervention arm compared to the comparator arm,To assess if the proportion of participants with maternal deaths is lower in the intervention arm compared to the comparator arm.,To assess if the proportion of participants with emergency hysterectomy, is lower in the intervention arm compared to the comparator arm., To assess the safety of REBOA in a national referral hospital in a low-income country like Uganda.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy, can be decreased from 50 % in the comparator arm (using standard of care alone) to 30 % or less in the intervention arm (using REBOA). ,
 Kampala, Kawempe
 Uganda 2023-11-13 12:15:41 2026-11-13 10 women in phase IIb and 212 women in Phase III (222 IN TOTAL) Women aged 18 and above years and emancipated minors with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg will be recruited Centre For International Health Medical and Health Sciences Clinical Trial Non-degree Award
Stephen Okoboi
ID: UNCST-2019-R001356
 Peer Delivered HIV/Syphilis Self-Testing with Assisted Partner Notification Services for Men who Have Sex with Men (MSM) in Uganda
REFNo: HS3021ES

Estimate the cost-effectiveness of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing.,Conduct a pilot randomized trial to pilot test the preliminary effectiveness of peer delivered HIV/syphilis self-tests and partner services versus facility-based testing., Conduct formative research to inform implementation of peer delivered self-tests for HIV and syphilis with partner services for Ugandan MSM. ,
 Uganda 2023-10-31 19:59:00 2026-10-31 200 Inclusion criteria: In both arms, peers will recruit network members who are 1) aged 18 years and older, 2) Self-report of anal sexual intercourse at least once in the prior quarter 3) self-identify as MSM, 4) not tested in past 3 months or never tested for HIV or syphilis before; 5) willing to provide informed consent; 6) willing to undergo study procedures National Institute of health Medical and Health Sciences Clinical Trial Non-degree Award
Prudence Beinamaryo
ID: UNCST-2023-R007239
 Efficacy of the combination ivermectin and albendazole vs albendazole alone in school-aged children infected with Trichuris trichiura: a randomized controlled trial
REFNo: HS3160ES

To evaluate the safety and tolerability of the ,To determine the CRs and ERRs of the study drugs (i.e. albendazole alone, albendazole-ivermectin) against Ascaris lumbricoides and hookworm in co-infected participants.,To determine the egg reduction rates (ERRs) of ivermectin/albendazole combination therapy compared to albendazole monotherapy against T. trichiura,To demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of CRs against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years.,
 Kabale, Rukore
Kabale, Rukore
 Uganda 2023-10-04 13:42:09 2026-10-04 750 School age children of from Age 6-12 both males and female of any tribe residing in area. Prof. Dr. Jennifer Keiser Medical and Health Sciences Clinical Trial Non-degree Award
Andrew Odur
ID: UNCST-2022-R009128
 A RANDOMIZED CONTROL TRIAL TO DETERMINE THE EFFICACY OF MACHINE LEARNING MODELS TO PREDICT POSTPARTUM HEMORRHAGE
REFNo: HS3132ES

Determine whether earlier knowledge of the high-risk patient likelihood of morbidity can change clinical management to better outcomes,Demonstrate the efficacy of a mobile app prediction-based platform in informing clinical judgment,Determine the suitability of mobile app-based platform integration into the clinical workflow of African obstetricians,Determine the efficacy of ML models to predict the likelihood of pregnancy complications among African mothers,We aim to conduct a randomized control trial to determine the efficacy of machine learning models to predict postpartum hemorrhage to potentially establish a new gold standard way of screening patients in low-resource settings,
 Lira, Cathedral
 Uganda 2023-10-02 15:32:14 2026-10-02 RCT sample size will be 200 The study will enroll pregnant women 18 years and older attending ANC at Lira Regional Referral Hospital intending to deliver from the same facility residing within 10 km distance from the hospital. INFIUSS Health, Inc Medical and Health Sciences Clinical Trial Non-degree Award
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
 REDUCING MORTALITY IN ADULTS WITH ADVANCED HIV DISEASE (REVIVE)
REFNo: HS2892ES

To determine whether azithromycin is effective in reducing the incidence of new infection compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is effective in reducing mortality and hospitalisation at early and late timepoints (4weeks and 24weeks) compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is an effective and safe intervention to reduce excess mortality in adults with advanced HIV (CD4 ≤ 100 cells/mm3). ,
 All Districts, Not applicable
 Uganda 2023-09-27 17:43:49 2026-09-27 8000 18 years and above, all sexes and all tribes Population Health Research Institute (PHRI) Canada Medical and Health Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria.
REFNo: HS2817ES

Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria.
Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
All parts:
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria


 Tororo, Tororo
Tororo, Tororo
 Uganda 2023-09-26 11:55:15 2026-09-26 Part A 12,pART b18 The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Buwembo Rogers
ID: UNCST-2021-R011765
 QUALITY OF SELF-CARE FOR OLDER (AGED 60 YEARS AND ABOVE) PEOPLE WITH DEMENTIA IN WAKISO DISTRICT, UGANDA. CAREGIVER PERCEPTIONS, AND EFFECTS OF A PSYCHOEDUCATION INTERVENTION ON QUALITY OF SELF-CARE.
REFNo: HS2958ES

To determine the effect of a remotely delivered psychoeducation intervention for caregivers of older people with dementia on the quality of self-care.,To explore the perception, caregivers of older people with dementia have towards quality of self-care.,To measure the quality of self-care for older people with dementia in Wakiso district, Uganda.,To Improve quality of self-care provided to older people with dementia through use of a remotely delivered psychoeducation intervention of caregivers of older people with dementia in Wakiso, district Uganda.,
 Wakiso, Kiwenda
 Uganda 2023-09-19 7:51:22 2026-09-19 71 Caregivers of older people diagnosed with dementia, 18-70 years, both female and males, all tribes as applicable Brain Health Training Program Medical and Health Sciences Clinical Trial Degree Award
Edrisa Mutebi Ibrahim
ID:
Safety of JNK61 in Healthy Human Volunteers.
REFNo: HS2474ES

To determine the effect of JNK61 on the blood sugar levels in healthy human volunteers.,To determine the safety of JNK61 in healthy human volunteers,
 Kampala, Makerere University
 Uganda 2023-08-30 16:05:54 2026-08-30 50 Male and female adults of any tribe Government of Uganda through Makerere University Research and Innovations Fund Medical and Health Sciences Clinical Trial Non-degree Award
Joseph  Matovu KB
ID: UNCST-2020-R014654
 Enhancing communication on relationship preservation, safer conception, and pre-exposure prophylaxis (PrEP) to promote HIV testing
REFNo: HS3025ES

Conduct a pilot trial of “PrEPing Healthy Families” with intervention sites implementing the novel communication,Conduct formative research to expand a communication strategy focused on relationship preservation and safer conception into a multi-component intervention with broader reach,To leverage the growing availability of PrEP to determine if and how a communication strategy focused on relationship preservation and safer conception can increase testing and entry into treatment (ART) or prevention (PrEP) among couples in Uganda,
 Mukono, Ntaawo ward
Mityana, Central ward
Butambala, Gombe ward
 Uganda 2023-08-25 8:26:15 2026-08-25 267 The proposed study will recruit up to 267 total participants. These participants include project advisory board members (up to 25) clients in assisted partner notification (APN) or antenatal care (ANC) programs (up to 36 for in-depth interviews [IDIs], up to 150 for exit surveys), their partners (up to 36 for IDIs), and ANC/APN providers at the intervention site (up to 20). Participants will all be aged 18 years and above and all sexes. Glenn Wagner Medical and Health Sciences Clinical Trial Non-degree Award
Mark Kaddumukasa
ID: UNCST-2020-R001798
 SELF MANAGEMENT INTERVENTION FOR REDUCING EPILEPSY BURDEN AMONG UGANDANS WITH EPILEPSY
REFNo: HS2944ES

1. To assess the efficacy of SMART- U vs. eTAU via an RCT.
H1: Individuals randomized to SMART-U will have significantly improved QOL and fewer seizures compared to eTAU.
H2: Individuals randomized to SMART-U will have greater improvement in depression and functional status compared to eTAU.
2. To use short message service (SMS) delivered via mobile phone text to validate patient self-reported seizure occurrence and push epilepsy self-management messaging in a practical/accessible format.
3. To obtain input from stakeholders (patients, family and clinicians) guided by an Integrated Promotion Action on Research Implementation in Health Services (i-PARIHS) framework to help establish sustainable infrastructure that will facilitate future scale up of SMART in Uganda with epilepsy partners

 Kampala, Mulago
Mbarara, Mbarara
 Uganda 2023-08-25 8:11:10 2026-08-25 188 Target population: all adult patients attending the neurology clinic at Mulago and Mbarara hospitals. Accessible population: All adult patients with epilepsy on treatment attending the clinic during the study period. Study population: All adult patients with epilepsy on treatment who will meet the inclusion criteria from all tribes attuning the study clinics. All consecutive adult patients who came either for follow up or as new referrals with confirmed diagnosis of epilepsy were screened for the inclusion into the study. NIH/ USA Medical and Health Sciences Clinical Trial Non-degree Award
Sharon Pang Sze Lu
ID:
Transform Randomised Controlled Trial in Uganda
REFNo: SS1823ES

To evaluate the impact of the Transform program on the key indicators in values, health and livelihood in Uganda
 Hong Kong 2023-08-25 8:07:30 2026-08-25 4800 The study population will include participants aged 18 to 90 years old. Both male and female participants are included in the study. ICM will first choose communities and identify 30 ultra-poor households for its Transform program (administered across control and treatment groups). Eligibility for Transform is determined using poverty assessment via an asset-based scoring and self-reported household income. Historically, there have been an average of 30 households per community. With a target sample size of 160 communities, we will have approximately 4,800 households in the study. ICM targets communities to receive a Transform program based on the proportion of community members living in ultra-poverty (less than USD $0.50/person/day).Participants who are above the threshold using the poverty assessment will be excluded from the study. Households also cannot participate in the study if they have previously received the Transform program, unless the implementation team overrides the score due to specific circumstances that only affect a minority of participants. International Care Ministries Social Science and Humanities Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 An adaptive, randomized, active-controlled, open-label, sequential cohort, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric participants with severe Plasmodium falciparum malaria (KARISMA – KAE609’s Role In Severe Malaria)
REFNo: HS1980ES

Primary objective
To assess the efficacy of different doses of
intravenous cipargamin vs artesunate by evaluating the proportion of
participants with ? 90% reduction of parasitemia at 12 hours post
administration of the first dose.

Secondary Objectives
1. To assess the presence/absence of severe malaria related individual
signs over time
2. To evaluate parasite clearance dynamics and proportion of participants
with recrudescence and reinfection
3. To assess recovery of participants as measured by time (days and hours)
to discharge from hospital or recovery from prostration
4. To evaluate the safety and tolerability of IV cipargamin
5. To assess the risk of long term neurological sequelae for participants at
Day 29
6. The assess the risk of hemolysis (early and delayed) during the study
duration
7. To characterize the plasma pharmacokinetics of IV cipargamin

 Tororo, Masafu
 Uganda 2023-08-18 9:05:14 2026-08-18 200 patients for AL treatment arm and 100 patients for the other treatment arms per site. At least two drugs will be studied per site The study population will consist of male and female participants, including pediatric participants aged ? 6 months or older. Approximately 252 participants (60 participants of ? 12 years and 192 participants < 12 years) will be randomized Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2748ES

Main Objectives:
1. Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria

Secondary Objectives
1. Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
3. To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
4. To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria
 Uganda 2023-08-10 13:49:44 2026-08-10 14 The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Bernard Kikaire
ID:
Effect of an interactive SMS system in improving the reporting of adverse drug reactions among people living with HIV in Tanzania and Uganda: a randomized controlled trial: The REMIND ADR TRIAL
REFNo: HS2922ES


To investigate the effectiveness of SMS reminders on improving ADR reporting compared to no SMS among people living with HIV in Tanzania and Kampala Uganda.
To describe the most commonly reported ADR profiles among people living with HIV in Tanzania and Uganda.
To determine the most common routes/ methods of reporting ADR used by PLHIV.
To explore the causal relationship between the commonly reported ADRs and ART.
To improve treatment options for participants who reported ADR.
To explore the technical feasibility and acceptability of the intervention in reporting ADR among PLHIV.

 Kampala, mulago
 Uganda 2023-08-08 12:42:32 2026-08-08 114 Age between 18 and 65 confirmed and documented HIV infection Being on ART treatment for less than one year Able to read and understand SMS Able to understand and willing to sign the informed consent document Able to read and write a text message Have a mobile phone The study is funded by Eastern Africa Consortium for Clinical Research (EACCR3) which is a network of excellence under EDCTP Medical and Health Sciences Clinical Trial Non-degree Award
Joseph Lutaakome
ID: UNCST-2020-R008323
 Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE)
REFNo: HS2703ES

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) is a master protocol being conducted in many countries around the world, and funded by the National Institutes of Health, USA. STRIVE will evaluate the safety and effectiveness of unlicensed and licensed treatments and different combinations of treatments, to improve the health outcomes of adults
hospitalised with acute respiratory infections, like COVID-19 or influenza.
 Kampala, Kampala
Masaka, Masaka
Gulu, Gulu
Lira, Lira
 Uganda 2023-08-08 12:39:21 2026-08-08 1,500 The participant population are non-pregnant or breast-feeding adults aged ≥ 18 years; with confirmed COVID-19 for <14 days, and requiring inpatient hospital acute medical care and with evidence of a COVID-19 lower respiratory tract infection. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
 A phase 2, partially-blinded, randomised trial assessing the safety and efficacy of TBAJ876 or bedaquiline, in combination with pretomanid and linezolid in adult participants with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis
REFNo: HS2928ES

The objectives of the trial are to evaluate the efficacy, safety, and tolerability of TBAJ876 (3 doses) or bedaquiline in combination with pretomanid and linezolid in adult participants with newly diagnosed, smear-positive pulmonary DS-TB in comparison to the SOC
 Kampala, Mulago
Kampala, Lubowa
 Uganda 2023-08-07 15:20:08 2026-08-07 The trial is planned to randomise at least 60 participants per treatment arm, for a total of at least 300 participants randomised. Study population should have the following characteristics: 1. Signed written informed consent prior to undertaking any trial-related procedures. 2. Participants aged 18 to 65 years, inclusive. 3. Body weight (in light clothing and no shoes) ≥35 kg. 4. Sputum positive for tubercle bacilli (at least 1+ on the IUATLD/WHO scale on smear microscopy) at the trial laboratory. 5. DS-TB participants defined as the following: a. Sensitive to rifampicin and isoniazid by rapid sputum-based test (see trial Mycobacteriology Laboratory Manual) AND b. Either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB. 6. A chest x-ray during the screening period or within 14 days of screening which in the opinion of the investigator is compatible with pulmonary TB. 7. Be of non-childbearing potential OR using effective methods of birth control as defined below: Non-childbearing Potential a. Participant is not heterosexually active or practices sexual abstinence OR b. Female participant or male participant’s female sexual partner: bilateral oophorectomy, bilateral tubal ligation, and/or hysterectomy or has been postmenopausal with a history of no menses for at least 12 consecutive months OR c. Male participant or female participant’s male sexual partner: vasectomized or has had a bilateral orchidectomy at least 3 months prior to screening Effective method of birth control is defined as 1 of the following: a. Double-barrier method which can include a combination of male condom, diaphragm, cervical cap, or female condom. Note: Female and male condom should not be used together. b. Combination of a barrier method with hormone-based contraceptives or an intrauterine device. Both male and female participants must be willing to continue practicing birth control methods and not be planning to conceive throughout treatment and for 6 months after the last dose of IMP. References to male or female mean “assigned male or female at birth,” respectively. TB Alliance Medical and Health Sciences Clinical Trial Non-degree Award
Proscovia Nabunya
ID: UNCST-2019-R000970
 Say No to Stigma-Round 2: Pilot testing the impact of visuals designed to reduce mental health stigma among primary school students in Uganda
REFNo: SS1818ES

Examine the acceptability and preliminary impact of the Say No to Stigma visual solutions on children’s mental health awareness and stigma in schools.
 Uganda 2023-07-27 20:55:02 2026-07-27 100 One hundred (100) students in total will be recruited for this study. Inclusion Criteria: Children: 1) ages between 8 to 13 (primary 2 to 7) enrolled in the selected school. Exclusion Criteria: 1) inability to comprehend study procedures or participant rights as assessed by trained staff during the informed consent process; or 2) they are unwilling or unable to commit to completing the study. Washington University in St. Louis Social Science and Humanities Clinical Trial Non-degree Award
Grace Mirembe
ID: UNCST-2022-R008850
 RV 591 entitled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults”
REFNo: HS2891ES

To assess the safety, reactogenicity and tolerability of two vaccination regimens: rapid dose-escalation of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV or co-administration of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV
 Kampala, Central
 Uganda 2023-07-14 9:49:16 2026-07-14 50 Healthy male and female participants, aged 18 to 50 years The Surgeon General, Department of the Army Medical and Health Sciences Clinical Trial Non-degree Award
Joy Gumikiriza- Onoria Louise
ID:
Development of a Caregiver Centered Psychotherapy (CCPT) in addressing patient care for older persons with Alzheimer’s Disease and Related Dementias (ADRD) in Uganda.
REFNo: HS2909ES

1. To explore ways in which older people in the community of Wakiso district conceptualize ADRD and what informs their opinions. 2. To assess caregiver distress, non-professional techniques of patient care, quality of life and the associated factors among family caregivers of persons with ADRD in Wakiso district.To adapt and pre-test the WHO-iSupport for family caregivers of persons with ADRD in Wakiso, Uganda4. To determine the effectiveness of A-iSupport in the alleviation of distress among family caregivers of persons with ADRD in Wakiso, Uganda
 Wakiso, Busukuma
Wakiso, Nansana
 Uganda 2023-07-14 9:40:03 2026-07-14 180 All residents of Wakiso district aged 60 years and older, includidng caregivers of persons with ADRD BRAIN health Medical and Health Sciences Clinical Trial Degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO-TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER (HeredERA)
REFNo: HS2968ES

To identify and/or evaluate biomarkers that are predictive of response to Phesgo and giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to Phesgo and giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of Phesgo and giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety,To evaluate potential effects of ADAs,To evaluate the immune response to pertuzumab, trastuzumab, and rHuPH20,To evaluate the potential relationships between Phesgo and giredestrant exposure and the safety, efficacy, immunogenicity, or biomarker endpoints.,To characterize the giredestrant, pertuzumab, and trastuzumab PK profile when given in combination,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo from the participant's perspective,To evaluate health utility of participants treated with Phesgo plus giredestrant compared with Phesgo to generate utility scores for use in economic models,To evaluate effects of Phesgo plus giredestrant compared with Phesgo on work productivity and activity,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo,To evaluate the efficacy of Phesgo plus giredestrant compared with Phesgo,
 Kampala, Mulago
 Uganda 2023-07-14 12:43:26 2026-07-14 20 This study will enrol patients with locally advanced or metastatic receptor positive breast cancer above 18 years of age La Roche Hoffman Medical and Health Sciences Clinical Trial Non-degree Award
Angella Natukunda
ID:
DETERMINANTS OF NUTRITION STATUS AMONG ADOLESCENTS IN SELECTED SECONDARY SCHOOLS OF KANUNGU DISTRICT SOUTH WEST REGION UGANDA
REFNo: SS1812ES

Broad obective To investigate the determinants of nutrition status among adolescents in selected secondary schools in Kanungu District South West Uganda. Specific objectives To assess the nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the social demographic and economic factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the diet-related factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the level of adolescent nutrition knowledge associated with nutrition status among adolescents in the selected secondary schools of Kanungu District South West Region Uganda.
Uganda 2023-07-14 12:34:44 2026-07-14 370 The study population will constitute of adolescents both male and female studying in secondary schools of Kanungu district 12 to 19 years. Natukunda Angella Social Science and Humanities Clinical Trial Degree Award
Rhoda Wanyenze
ID: UNCST-2021-R013352
 A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention (GC-CCP) in Uganda
REFNo: SS1873ES

1. Conduct a multisite RCT of the GC-CCP network-based advocacy strategy to evaluate effects on CC screening uptake, access to early-stage treatment and prevention of advanced disease among unscreened alters across urban/rural and public/private clinics,4. Evaluate the cost-effectiveness of Implementing GC-CCP to increase CC screening and low cost, early-stage treatment, and prevent advanced disease, compared to enhanced usual care.,3. Examine mediators and moderators (among index, alter and network characteristics) of intervention effects on (a) alter CC screening; and (b) engagement in CC prevention advocacy of index and alter (1st and 2nd degree) to better understand its multiplier effect on diffusion of advocacy throughout a network.,2. Use a mixed methods approach (semi-structured interviews and administrative clinic data) to examine clinic-, provider-, and client-level barriers and facilitators of GC-CCP Implementation and Sustainment.,
 Kampala, Nsambya
Kampala, Kawempe
Buikwe, Buikwe
Kayunga, Kayunga
 Uganda 2023-07-13 11:13:19 2026-07-13 1400 women Women recently screened for Cancer of the Cervix and aged 25 years and above will be enrolled as index participants, Women who have not screened for Cancer of the Cervix but are network members of index participants will be enrolled as alter participants, Clinic leadership and providers of Cervical Cancer services will participate in qualitative interviews. National Institute of Mental Health Social Science and Humanities Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (Lidera)
REFNo: HS2193ES

Main Objective

1. To demonstrate superiority of giredestrant over the control treatment.
Specific Objectives

1. To evaluate the efficacy of giredestrant compared with Therapy of Physician's Choice
2. To evaluate the safety of giredestrant compared with Therapy of Physician's Choice
3. To characterize giredestrant Pharmacokinetics
4. To evaluate health status utility scores of participants treated with giredestrant compared with Therapy of Physician's Choice
5. To evaluate the tolerability of giredestrant compared with Therapy of Physician's Choice
6. To identify and/or evaluate biomarkers that are predictive of response to giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety
 Kampala, Mulago
Uganda 2023-07-13 10:07:44 2026-07-13 18 women aged 18 years of age and over with histologically confirmed breast cancer Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children.
REFNo: HS2931ES

The primary objective of this study is to confirm the dose of B/F/TAF FDC in HIV-1 infected pediatric participants, to confirm the dose of B/F/TAF TOS in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
Kampala,
Uganda 2023-07-06 17:23:47 2026-07-06 5 Adolescents and children Gilead Sciences Medical and Health Sciences Clinical Trial Non-degree Award
Thomas McHale
ID: UNCST-2022-R008812
 Optimizing the Dose of Flucytosine for Cryptococcal Meningitis
REFNo: HS2940ES

Determine if 50 mg/kg/day of 5-FC has a similar mortality benefit compared to 100 mg/kg/day,Reduce the cost and supply burden of treating an individual with cryptococcal meningitis,Determine if 50 mg/kg/day of 5-FC is a safer dosage compared to 100 mg/kg/day of 5-FC,Determine if 50 mg/kg/day of 5-FC is has a similar rate of cryptococcal clearance from CSF compared to 100 mg/kg/day,Determine the optimal dose of 5-FC for for management of induction phase of therapy for cryptococcal meningitis,
 Kampala,
Mbarara,
USA 2023-07-05 11:41:24 2026-07-05 The target sample size is 50 participants The study will enroll adults with HIV who are over 18 years old and sick with cryptococcal meningitis. National Institute of Health, United States Medical and Health Sciences Clinical Trial Degree Award
Daniella Akellot
ID:
EVALUATION OF THE EFFECTIVENESS OF CLORPACTIN IN COMPARISON WITH OTHER WOUND DRESSING AGENTS USED AT SIGN SUPPORTED HOSPITALS IN UGANDA
REFNo: HS2769ES

To determine the effectiveness of Clorpactin in wound dressing at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor.,
 Kumi, Booma South
Gulu, ForGod
 Uganda 2023-07-03 13:32:54 2026-07-03 546 patients Patients admitted at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor with surgical wound sepsis, infected open fractures, diabetic wounds, chronic osteomyelitis. SIGN Fracture Care International Medical and Health Sciences Clinical Trial Non-degree Award
Ezekiel Mupere
ID: UNCST-2023-R008637
 Earlier prime-BOOST schedule to improve MEasles protection in high burden settings (BoostME)
REFNo: HS2883ES

Safety Objectives 1.To assess the safety and reactogenicity profile of the vaccine when given at different ages 2.To assess the number of measles infections throughout the study. Primary Objectives 1.To compare protective measles antibody concentrations at 2.5 years of age in infants receiving an early (6 months) compared to standard (9 month) dose of MCV, and a booster dose at 18 months of age. 2.To compare protective measles antibody concentrations one month after a second dose of MCV given at 12 months (early) compared to standard (18 months), in those who received an early (6 months) first dose. Secondary Objectives •To describe the measles antibody concentrations one month after first dose in infants receiving an early (6 months) compared to standard (9 month) dose of MCV. •To describe the effect of maternal antibodies on infant humoral and cellular immune response to first and second doses in children vaccinated under different schedules. •To describe the effect of maternal HIV infection on infant antibody responses post MCV1 and MCV2 given at different schedules •To describe the impact of different vaccination schedules on responses to the rubella component of the vaccine. Community Objectives To assess the effect of a measles vaccination clinical trial on public perceptions of measles immunisation
 Kampala, Kawaala
Kampala, Kisenyi
Kampala, Komamboga
Kampala, Mulago
 Uganda 2023-06-23 7:46:04 2026-06-23 450 infants Any infant aged 6 months (23-28 weeks) at screening visit and has not received prior vaccination against measles University of Oxford Research Governance, Ethics and Assurance Joint Research Office Boundary Brook House Churchill Drive Headington Oxford OX3 7GB United Kingdom, and funded by Bill and Melinda Gates Foundation. Medical and Health Sciences Clinical Trial Non-degree Award
Tonny Kiyimba
ID:
Efficacy of polyphenols from Tamarindus indica fruit juice on cardiometabolic health of patients living with HIV and elevated triglycerides: A study protocol
REFNo: HS2923ES

3. To establish dose response dynamics of long-term intake of T. indica fruit juice polyphenols on selected cardiometabolic risk markers of PLWH.,2. To assess the effect of an acute, single-dose intake of T. indica fruit juice on vascular function, lipid profile and plasma levels of procyanidin metabolites.,1. To produce and evaluate the sensory acceptability of T. indica fruit juice.,To determine the efficacy of T. indica fruit juice on selected cardiometabolic risk markers of PLWH in HIV community care model in Wakiso district, Uganda.,
 Wakiso, Kajjansi
Wakiso, Kajjansi
 Uganda 2023-06-20 11:05:36 2026-06-20 240 Participants will be adult(30-50 years) male and female patients living with HIV (PLWH) managed under the community-based model (Community Drug Distribution Points-CDDPs) in Wakiso district, central Uganda. The district encircles Kampala, Uganda's capital city with an estimated population of over 2.9 million people. The district has the highest prevalence (10%) of HIV in Uganda. Over 3,801 PLWH are currently receiving the HIV care from CDDPs in Wakiso District. The study inclusion and exclusion criteria are presented in Table 1. VLIROUS Medical and Health Sciences Clinical Trial Degree Award
Betty Mwesigwa
ID: UNCST-2020-R014667
 SABIN-002: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
REFNo: HS2838ES

To evaluate the safety and tolerability of
cAd3-Marburg vaccine
 Kampala, Nakasero
 Uganda 2023-06-14 11:06:46 2026-06-14 80 Male and female adults, 18-70 Years Sabin Vaccine Institute Medical and Health Sciences Clinical Trial Non-degree Award
NANKWASA SAILAS
ID:
RANDOMIZED CONTROLLED FOR NON USE OF ANTIBIOTIC AFTER UNCOMPLICATED VAGINAL BIRTH AND POST-PARTUM ENDOMETRITIS AT ST FRANCIS HOSPITAL NSAMBYA
REFNo: HS2768ES

3. To determine the factors that may predict the likelihood of infection after uncomplicated vaginal birth at St. Francis Nsambya Hospital,2. To determine the incidence of perineal tear/episiotomy wound breakdown among women who received antibiotic and those who do not at St. Francis Nsambya Hospital,1. To determine the incidence of post-partum endometritis after uncomplicated vaginal birth in women who receive antibiotic compared to those who do not at St. Francis Nsambya Hospital,To determine whether not providing an antibiotic after uncomplicated vaginal birth is associated with increased incidence of post-partum endometritis at St. Francis Nsambya Hospital,
 Kamuli, Nsambya
Uganda 2023-06-06 7:53:44 2026-06-06 260 participants adult post delivery mothers with uncomplicated vaginal birth NANKWASA SAILAS Medical and Health Sciences Clinical Trial Degree Award
RICHARD MPANGO STEPHEN
ID:
Adaptation and Evaluation of the New Forest Parenting Program (NFPP) in the management of ADHD among Children and Adolescents infected with HIV (CA-HIV) in Uganda (Formative phase)
REFNo: SS1721ES

i) To adapt and evaluate the effectiveness of the NFPP in the management of ADHD among Children and adolescents infected with HIV (CA-HIV).
ii) To evaluate the acceptability and feasibility of NFPP in the management of ADHD among CA-HIV.
 Masaka, NOT APPLICABLE
Kampala, NOT APPLICABLE
 Uganda 2023-05-29 20:36:58 2026-05-29 44 Twenty-two (22) participants; ten (10) Child and adolescent mental health specialists’ and HIV clinicians (representing a range of professional disciplines including psychiatrists, psychologists, psychiatric clinical officers, psychiatric nurses, experienced HIV counsellors and HIV clinicians); ten (10) parents / grandparents / teachers /day-mothers / guardians / caregivers; two (2) facilitators CHILD Global Research Social Science and Humanities Clinical Trial Degree Award
Richard Idro
ID: UNCST-2021-R013599
 Dihydroartemisinin-piperaquine and azithromycin for the post-discharge management of children with severe anaemia in Malawi, Kenya and Uganda; A, multicentre, parallel-group, two-arm, randomised, double-blind superiority trial.
REFNo: HS2815ES

To determine if PDMC with four courses of monthly AZ treatment in combination with four months of weekly DP is superior to PDMC with weekly DP-alone in reducing non-malaria SCCV by six months post-discharge in children aged <5 years admitted with severe anaemia (Hb<5g/dl) who are ready to be discharged and are clinically stable and able to switch to oral medication,
 Jinja, Jinja City
Kitgum, Municipality
 Uganda 2023-05-25 12:04:54 2026-05-25 958 Children aged less than 5 years, with severe anemia. Training and Research Unit of Excellence, Blantyre, Malawi Medical and Health Sciences Clinical Trial Non-degree Award
David Meya Bisagaya
ID: UNCST-2019-R000837
 Platform Trial For Cryptococcal Meningitis - PLATFORM-CM
REFNo: HS2649ES

The purpose of this study is to know whether this oral form of amphotericin (MAT2203) is safe and effective in the treatment of people sick with cryptococcal meningitis.
 Mbarara, Mbarara
Masaka, Masaka
Kampala, Kampala
 Uganda 2023-05-25 12:01:51 2026-05-25 270 Adult (18 years and above) males and females HIV-infected persons with cryptococcal meningitis. Matinas BioPharma Nanotechnologies, Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Dominik Biesalski
ID:
The Drivers, Effects and Measurement of Time Use Among the Urban Poor: Evidence from Uganda
REFNo: SS1674ES

Get insights into the time use patterns of urban workers and understand their effects on productivity and well-being.
 Kampala, Kampala
 Germany 2023-05-11 14:41:00 2026-05-11 200 Workers who are older than 18 years old, both men and women of all tribes Private Enterprise Development in Low-Income Countries (PEDL) Social Science and Humanities Clinical Trial Degree Award
James Davis KATUMBA
ID:
Uncontrolled asthma among adolescents in selected secondary schools in Kampala City: Prevalence, associated factors, in-school needs, pathways to care and effectiveness of an mHealth Self-management app
REFNo: HS2791ES

To determine the effectiveness, acceptability and feasibility of the KmAsthma self-management app in improving the control of asthma among day scholar secondary school adolescents 12-19 years old in Kampala City Uganda.,To examine pathways to asthma care and their influence on asthma control among secondary school adolescents with asthma in Kampala City Uganda ,To establish the in-school needs associated with asthma control among adolescents in selected secondary schools in Kampala City Uganda ,To determine the prevalence of and factors associated with uncontrolled asthma among adolescents in selected secondary schools in Kampala City Uganda ,To establish the prevalence of and factors associated with uncontrolled asthma, in-school needs, pathways to asthma care, and effectiveness of KmAsthma Self-management app intervention to control asthma among adolescents in selected secondary schools in Kampala City Uganda,
 Kampala, Kawempe, Rubaga, Makindye, Kampala Central, Nakawa
 Uganda 2023-05-02 22:22:49 2026-05-02 323 Secondary school adolescents in Kampala City Uganda who will provide written informed consent (or assent plus consent from parents in case of minors) during the time of the study. Self Sponsored Medical and Health Sciences Clinical Trial Degree Award
John Kellett Gale
ID:
Can continuous non-invasive monitoring of movement predict and detect clinical deterioration of hospital patients earlier and more efficiently than traditional intermittent observations?
REFNo: HS2765ES

To determine if continuously collected accelerometer data can indicate and identify clinical deterioration of acutely ill hospitalised patients before intermittently collected vital signs.
 Masaka, Ssenyange
 Ireland 2023-05-02 22:11:25 2026-05-02 1100 All non-pregnant patients aged 18 years or over admitted to the medical ward for any medical condition who are competent to provide consent to participate in the study or have a surrogate decision maker who can consent on their behalf. Patients may decide to participate or withdraw from the study at any time during their hospitalization. Dr John Kellett Medical and Health Sciences Clinical Trial Non-degree Award
Grace Ndeezi
ID: UNCST-2019-R001802
 Nutritional management of growth faltering in infants aged under six months. Study protocol for an individually randomised trial
REFNo: HS2766ES

To determine the effect of nutritional supplementation plus intensive breastfeeding support compared with intensive breastfeeding support alone on mortality, morbidity and growth in infants aged 0-6 months with growth faltering in low resource settings in South Asia and Sub-Saharan Africa.
Iganga,
Iganga,
Iganga,
Iganga,
Iganga,
Mayuge,
Mayuge,
Uganda 2023-04-26 11:15:23 2026-04-26 900 infants Pregnant women (and adolescents) aged 15 to 45 years. Their babies will be enrolled at birth for a nutritional intervention. Both female and male babies will be enrolled. There will be no exclusion based on tribe as long as they comprehend English and Lusoga. World Health Organisation Medical and Health Sciences Clinical Trial Non-degree Award
ELIZABETH ASIGE
ID:
THE IMPACT AND COST-EFFECTIVENESS OF A COMMUNITY-BASED PROGRAM FOR CHILDREN WITH CEREBRAL PALSY AND THEIR CAREGIVERS AND THE STAKEHOLDERS IN UGANDA.
REFNo: HS1979ES

1. To examine the impact of a community-based program on children with CP reported frequency of participation in the home, school, and community activities. 2. To assess the impact of a community-based training program on improving caregiver knowledge regarding CP and reducing caregiver stress. 3. To determine the impact of a communication and advocacy program in broadening stakeholders’ knowledge, attitude and practices regarding childhood disability and inclusion. 4. To determine the cost-effectiveness of a community-based program on children with CP, their caregivers, and the stakeholders in relation to costs and benefits.
Iganga, Iganga
Mayuge, Mayuge
 Uganda 2023-04-20 21:15:22 2026-04-20 100 participants- 50 in the study group and 50 in the control group The study population will comprise children and youth with cerebral palsy aged 2-22 years, both male and female, and their primary caregivers of any tribe living in the study communities plus the community stakeholders Prof. Hans Forssberg -Karolinska Institutet Astrid Lindgren Children’s Hospital 17176, Stockholm Sweden Medical and Health Sciences Clinical Trial Degree Award
Beatrice  Onyango Ekesa
ID:
Bio-efficacy of Pro-Vitamin A-rich banana to improve vitamin A status among children in Uganda living in an area with a high burden of inflammation
REFNo: HS2721ES

3. Establish the stability of retinol isotopes on DSS at room temperature in the determination of TBS of vitamin A.,2. Assess the effect of inflammation and nutritional status on vitamin A absorption and TBS assessment among school-aged Ugandan children.,1. Determine the bio-efficacy of carotenoids in Pro-Vitamin A rich bananas in improving TBS in children aged 6-14years.,This study will determine the bio-efficacy of carotenoids in Pro-Vitamin A-rich banana-based diets and their potential in improving the vitamin A body stores by the RID technique among school-going children aged 6-14years living in Tororo district, an area with a high burden of inflammation.,
 Tororo, Aturukuk
 Kenya 2023-04-19 12:44:24 2026-04-19 110 The study will be conducted among school going children aged 6-14 years because the school setting facilitates the feeding trial and monitoring, and the age group forms the youngest group available in an organised setting that can easily be engaged for a long period. In addition, this age group is not involved in the current national vitamin A supplementation programs. International Atomic Energy Agency (IAEA) Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Evaluation of National HIV Testing Services Algorithm
REFNo: HS2701ES

Main Objective
To determine the appropriate HIV rapid test algorithm to be used in Uganda considering the new kits on the market.

Specific objectives
1. To assess specificity, sensitivity, negative predictive value (NPV), positive predictive value (PPV) of the rapid HIV tests on the market in Uganda and come up with best RDT algorithm.
2. To identify an algorithm that will best identify acute HIV infections
3. To determine the inter-observer and inter-lab agreement in HIV diagnosis using evaluated RDTs.

 Gulu, Lacor hospital
Mbarara, Mbarara hospital
Tororo, AIC and TASO
Central Region, UVRI CLINIC
 Uganda 2023-04-12 15:44:58 2026-04-12 3500 Adults aged 18 years and above who would have come for an HIV test The Global Fund Medical and Health Sciences Clinical Trial Non-degree Award
Francis Ssali
ID: UNCST-2021-R012134
 Protocol A5394: “Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV” Version 1.0, May 27, 2022
REFNo: HS2647ES

1.2 Primary Objectives

1.2.1 To assess the safety and tolerability of treatment with SLGN administered once weekly by mouth for 24 weeks.

1.2.2 To determine the proportion of participants with ≥1 log10 IU/mL decline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24.

1.3 Secondary Objectives

1.3.1 To determine the proportion of participants with ≥1 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.2 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg after SLGN treatment at Week 24.

1.3.3 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.4 To evaluate the proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up.

1.3.5 To evaluate changes in qHBsAg levels at Weeks 4, 12, 24, 36, and 48 after SLGN initiation and, separately, among the placebo recipients.

1.3.6 To determine the proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study, by study arm.

1.3.7 To determine the proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study, by study arm.

1.3.8 To determine the proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study, by study arm.
1.3.9 To evaluate levels of circulating cytokines, including IFN-gamma, IL-12p40, IL-1RA, and CD163 at entry, 24 hours post-first study drug dose, Weeks 4, 12, 24, 36, and 48, by study arm.

1.3.10 To determine whether administration of SLGN will perturb HIV latency as measured by an increase in HIV transcription.

1.3.11 To determine whether administration of SLGN will decrease the size of the latent reservoir, as measured by the change in amount of cell-associated unspliced HIV RNA, HIV DNA, replication-competent and/or intact virus at Weeks 2, 4, 24, and 48.

1.4 Exploratory Objectives

1.4.1 To define the pharmacokinetic (PK) profile and PK-pharmacodynamic (PD) associations of SLGN in people with both HIV and CHB taking suppressive antiviral therapy for both viruses.

1.4.2 To explore if SLGN and antiretroviral (ARV) PK are altered when administered together.

1.4.3 To evaluate participants’ adherence by using several tools, including self-report, directly observed therapy (DOT), and drug concentrations.

1.4.4 To compare quantitative changes in experimental measures of HBV antiviral efficacy (including HBV RNA, hepatitis B core related antigen [HBcrAg], qHBeAg, and low positive HBsAg measured with a high sensitivity qHBsAg assay [LLOQ of 0.05 IU/mL]) and measure changes in large, medium, and small HBsAg isoforms from baseline during and after treatment.

1.4.5 To determine the immunological effects of SLGN on circulating immune signaling by performing single cell RNA sequencing using peripheral blood mononuclear cells (PBMCs) and evaluating HIV-specific T-cell responses.

1.4.6 To determine the effects on circulating immune cells, including cellular phenotypes and T and B-cell responses.

1.4.7 To determine whether administration of SLGN will affect levels of circulating cytokines, including TNF-alpha, IL-12, IL18, IP-10, ISG15, IL-21, Fas Ligand, and TRAIL.

 Kampala, Seguku
 Uganda 2023-04-12 14:38:49 2026-04-12 The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if replacements are needed for key analyses. Participants with both (1) HIV and chronic hepatitis B (CHB) on suppressive effective antiviral therapy for HIV (ART) and HBV for ≥5 years immediately prior to study entry and (2) screening quantitative hepatitis B surface antigen (qHBsAg) >1000 IU/mL, and without evidence of advanced liver fibrosis or cirrhosis. Enrollment of women (female sex assigned at birth) is encouraged, and the study will set an enrollment goal of at least 14 women. The study is expected to enroll participants in North America, South America, Africa, and Asia. For the first 9 months, enrollment will be capped at 24 participants at US sites and 24 participants at non-US sites. After 9 months, enrollment will be open to all sites without regional caps The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if r eplacements are needed for key analyses. There are no Uganda specific differences. National Institute of Allergy and Infectious Diseases, Gilead Sciences, Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 A multiple arm, multiple stage (MAMS), phase 2B/C, open label, randomized, controlled platform trial to evaluate experimental arms including an increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin and sutezolid, in adult subjects with newly diagnosed, smear-positive pulmonary tuberculosis
REFNo: HS2644ES

Primary Efficacy Objective:
Rifampicin- containing experimental arms (arms 1,2)
To evaluate whether one or more of two experimental regimens based on
optimized dose rifampicin, optimized dose of pyrazinamide, and moxifloxacin
given for 12, respectively 17 weeks, are superior to standard treatment given for
26 weeks, as assessed by time to sputum culture conversion to negative in liquid
media.
Sutezolid-containing experimental arm (arm 4)
 To evaluate whether the efficacy of an experimental regimen composed of
sutezolid, delamanid, bedaquiline, and moxifloxacin given for 17 weeks is
superior to standard treatment given for 26 weeks, as assessed by time to
sputum culture conversion to negative in liquid media.
Secondary Objectives This study’s secondary objectives are:
Efficacy
 To assess treatment efficacy based on proportion of patients with relapse
free outcome at 12 months after randomization.
 To assess treatment efficacy based on the rate of decline of bacterial load
measured by the Molecular Bacterial Load Assay
 To rank the relative efficacy of the experimental four-drug combinations
for the treatment of pulmonary tuberculosis within the first twelve weeks
of treatment, and select the most efficient experimental treatment
regimen or regimens for further development.
Safety and Tolerability
To assess the frequency, severity, and type of adverse events (AEs), and AErelated
treatment discontinuations.
Pharmacokinetics
To describe the pharmacokinetics of the drugs and doses used, and to assess
possible relationships between pharmacokinetic parameters of the various drugs and between pharmacokinetic parameters and participant characteristics.
Pharmacodynamics To describe relationships between pharmacokinetic parameters on the one hand and efficacy and safety endpoints on the other hand.
 Kampala, Kawempe
 Uganda 2023-04-11 15:27:11 2026-04-11 360 Adults A total of up to 360 adult (≥ 18 years of age) participants will be enrolled. In case of a high number of dropouts or non‐evaluable participants, it may be necessary to recruit more participants into the study. Also, if the stage 2 starts later than stage 1, it will be necessary to increase the number of control arm participants to achieve a 1:1 ratio of concomitantly recruited control and arm 4 participants (see sample size considerations). Both males and females regardless of tribe as long as an ICF of that particular language spoken by the participant is available, will be enrolled. LMU Klinikum Marchioninistr. 15, 81377 Munich Germany Medical and Health Sciences Clinical Trial Non-degree Award
Brenda Kakayi Catherine
ID: UNCST-2022-R008787
 Insulin-like Growth Factor/Growth Hormone Levels and Stunting in HIV Exposed Uninfected Children from the 1077BF/P1084s study (CHASE: Changes in IGF/Hormone Axis and Stunting in HIV-Exposed uninfected children.
REFNo: HS2686ES

1. To investigate IGF-1, IGFBP-1, and IGFBP-3 as predictors of growth faltering/stunting in the first 2 years of life in HEU children

2. To describe the concentrations of hormonal growth factors in infants in relation to infant growth percentile at birth, 26 weeks, and 74 weeks of age.

Uganda 2023-04-03 20:41:44 2026-04-03 Samples from approximately 154 participants from the P1084s study Samples of approximately 154 P1084s HEU children with serum specimens available at birth, week 26, and week 74 will have assays done on stored specimens for IGF-1, IGFBP-1, and IGFBP-3 at these time points. The 154 participants will be randomly selected from the 268 participants from Uganda, Malawi and South Africa that were enrolled in the study. The samples for use will be from both male and female participants. DAIDS-IMPAACT Network Medical and Health Sciences Clinical Trial Non-degree Award
JOSELYN RWEBEMBERA
ID: UNCST-2021-R013915
 Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease: A non-inferiority randomized trial. (GOALIE)
REFNo: HS2659ES

Primary Objective:
To compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.

 Lira, Adyel
 Uganda 2023-03-24 2:23:26 2026-03-24 1004 Age group = 5-17 Sex not specified. Tribe not specified. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Victoria Ndyanabangi
ID: UNCST-2021-R012645
 IMPAACT 2036: Phase I/II Study of the Safety, Tolerability,Acceptability, and Pharmacokinetics of Oral and Long-ActingInjectable Cabotegravir and Rilpivirine in Virologically SuppressedChildren Living with HIV-1, Two to Less Than 12 Years of Age, DAIDSStudy ID #38932 IND # 138754
REFNo: HS2688ES

To propose the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV)followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA)in children living with HIV-1, and to describe participant choice and experience with theregimen with or without an oral lead-in period.
To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable)through Week 24
To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oraland injectable) through Week 24
To assess the safety of CAB + RPV (oral and injectable) through Weeks 48 and 72
To describe the repeat-dose pharmacokinetics of injectable CAB LA + RPV LA throughWeeks 48 and 72
To assess the maintenance of viral suppression of CAB + RPV (oral and injectable)through Weeks 24, 48, and 72
To evaluate the tolerability and acceptability of injectable CAB LA + RPV LA throughWeeks 24, 48, and 72
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during study treatment
To assess immunologic activity of CAB + RPV (oral and injectable) through Weeks 24,48, and 72
To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable)and 44 weeks of CAB LA + RPV LA (injectable only)
To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV(oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe the maintenance of viral suppression and immunologic activity of 48 weeks ofCAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CABLA + RPV LA (injectable only)
To characterize long-term safety and washout PK through 48 weeks after permanentdiscontinuation of injectable CAB LA + RPV LAV LA
To characterize PK of CAB + RPV oral formulations when dispersed in liquid vs. directly ingested (Weight Bands 3, 4 and 5)
 Kampala, Mulago
 Uganda 2023-03-16 12:55:20 2026-03-16 35 Children living with HIV-1, two years to less than 12 years of age and weighing ≥10 kg and <40 kg, who are Virologically suppressed on stable antiretroviral therapy and their parents/caregivers. Proposed the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV) followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA) in children living with HIV-1, and to describe participant choice and experience with the regimen with or without an oral lead-in period. National Institute of Allergy and Infectious Diseases (NIAID) Medical and Health Sciences Clinical Trial Non-degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
 GS-US-380-1474: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
REFNo: HS2708ES

This is a multisite, multi-cohort study that aims to recruit subjects in four weight-based cohorts (i.e. Cohort 1, 2, 3 and 4), with each cohort having specific objectives aligned with it. Baylor Uganda site will recruit subjects in cohort 4 with is further subdivided in 4 weight-based sub-groups. The study objectives in relation to the Cohort 4 are as follows;
Cohort 4
Group 1:
The primary objective of this study is:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets

• To evaluate the antiviral activity of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Weeks 24 and 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
Group 2:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the antiviral activity of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg.
Group 3:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the antiviral activity of B/F/TAF 3.75/15/1.88 mg (administration of 1 × B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
Group 4:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg.

• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

• To evaluate the antiviral activity of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

 Kampala, Mulago
 Uganda 2023-03-16 12:47:17 2026-03-16 10 4.1 Selection of the Study Population Approximately 170 pediatric subjects ≥ 1 month to < 18 years of age are planned to be enrolled into the entire study. However, 50 child subjects shall be recruited as follows for Cohort 4 across all participating sites; at least 8 evaluable subjects ≥ 2 years of age weighing ≥ 14 to < 25 kg and at least 42 evaluable subjects ≥ 1 month of age weighing ≥ 3 to < 14 kg are planned to be enrolled. Baylor Uganda site however, plans to recruit a total of 10 children in cohort 4 (i.e. 3 children in each of the groups 1, 2 and 3 and 1 child in group 1). In addition, replacement subjects may be enrolled for subjects whose Intensive PK data are not evaluable or who do not complete all Intensive PK procedures in Groups 2, 3, and 4 of Cohort 4. 4.2 Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. a) Age ≥ 1 month to < 18 years (according to requirements of enrolling Cohort) b) Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements. c) Body weight at screening for Cohort 4: • Group 1: ≥ 14 to < 25 kg (≥ 31 to < 55 lbs) • Group 2: ≥ 10 to < 14 kg (≥ 22 to < 31 lbs) • Group 3: ≥ 6 to < 10 kg (≥ 13 to < 22 lbs) • Group 4: ≥ 3 to < 6 kg (≥ 6.6 to < 13 lbs) d) Confirmed HIV infection if < 18 months of age (positive nucleic acid-based test result to be provided). e) Adequate renal function: • Estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73 m2 (≥ 1.5 mL/sec/1.73 m2) for children ≥ 1 year of age using the Schwartz Formula. • Adequate renal function: eGFR ≥ the minimum normal values for age for children < 1 year of age using the Schwartz Formula. o Schwartz formula (mL/min/1.73 m2) = k × L/SCr where k is a proportionality constant, L is height in centimetres (cm) and SCr is serum creatinine (mg/dL). The value of k is 0.45 for children < 1 year old, 0.55 for children ≥ 1 to < 12 years old and adolescent girls ≥ 12 years old and 0.70 for adolescent boys (≥ 12 years old). f) Stable ARV regimen: • Stable ARV regimen of 2 NRTIs in combination with a third agent for a minimum of 6 months prior to the screening visit. Subjects undergoing dose modifications to their ARV regimen for growth or who are switching medication formulation(s) are considered to be on a stable ARV regimen (Cohort 4 Group 1). • Stable ARV treatment of 2 NRTIs in combination with a third agent for a minimum of 1 month prior to the screening visit or treatment naive (Cohort 4 Groups 2, 3, and 4 only) (patient is considered treatment naive if ARVs were given for prevention of mother-to-child transmission only and not for HIV treatment) g) Plasma HIV-1 RNA: < 50 copies/mL at the screening visit (Cohort 4 Group 1). No threshold for HIV RNA levels for Cohort 4 Groups 2, 3, and 4. h) Life expectancy ≥ 1 year. i) Have no documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. Subjects with M184V/I AND HIV-1 RNA < 50 copies/mL may be enrolled in Cohort 4. Subjects in Cohort 4 with HIV-1 RNA > 50 copies/mL shall have documentation of no FTC, TFV, or INSTI resistance by plasma testing at screening (> 200 copies/mL) or historical genotype (if > 50 copies/mL but < 200 copies/mL). j) Care taker(s) must be willing and able to comply with all study requirements. 4.3 Exclusion Criteria Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. a) Cohort 4 Group 1: CD4 cell count < 200 cells/ mm3. Cohort 4 Groups 2, 3, and 4: CD4 cell count < 750 cells/mm3 for ≥1 to <12 months of age and < 500 cells/mm3 for ≥12 to <24 months of age. b) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening. c) An ongoing serious infection requiring systemic antibiotic therapy at the time of screening d) Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months e) Acute hepatitis in the 30 days prior to study entry f) Hepatitis B virus (HBV) surface antigen (HBsAg) positive g) Hepatitis C virus (HCV) antibody positive with detectable HCV RNA. Children < 18 months of age born to an HCV positive mother and/or HCV antibody positive will need to have 2 negative HCV RNA tests 6 months apart with the first test occurring no earlier than 2 months of age. In this situation, the earliest such a patient can be screened for study eligibility is at 8 months of age. h) Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, haematological, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to Day 1. i) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy) j) A history of or ongoing malignancy other than cutaneous Kaposi’s sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study. k) ≤ 2 months of age and gestational age (GA) ≤ 37 weeks (Cohort 4 Groups 2, 3, and 4) l) Current alcohol or substance abuse (by parent/caretaker) judged by the Investigator to potentially interfere with subject compliance m) Have history of significant drug sensitivity or drug allergy n) Known hypersensitivity to the IMP, the metabolites, or formulation excipients. o) Participation in any other clinical trial, including observational studies without prior approval from sponsor is prohibited while participating in this trial. p) Cohort 4 Groups 2, 3, and 4: Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrolment q) Subjects receiving ongoing therapy with any medication that is not to be taken with the study drug. Administration of any of the following medications must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study, with the exception of the subject’s prior ARV treatment regimen, which must be continued until their scheduled Day 1 visit Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 Medical and Health Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 plus Pyronaridine Administered once Daily for 1 or 2 Days to Adults and Adolescents with Acute Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2736ES

To evaluate the safety and
tolerability of the M5717-
pyronaridine combination in
adult participants with acute
uncomplicated malaria due to
P. falciparum.
Secondary.
o describe the clinical efficacy
of the M5717-pyronaridine
combination in adult participants
with acute uncomplicated
malaria due to P. falciparum
 Tororo, Central
 Uganda 2023-03-16 12:35:56 2026-03-16 200 Participants Are ≥ 12 and ≤ 55 years of age (≥ 18 and ≤ 55 years of age for Part A) at the time of signing the informed consent. Type of Participant and Disease Characteristics: 2. Microscopic confirmation of acute uncomplicated P. falciparum using Giemsa-stained thick and thin film. 3. P. falciparum parasitemia of ≥ 1,000 to ≤ 50,000 asexual parasites/µL of blood in Part A and P. falciparum parasitemia of > 1,000 to ≤ 150,000 asexual parasites/µL of blood in Part B. 4. Axillary temperature ≥ 37.5ºC or tympanic temperature ≥ 38.0ºC (use as per COVID-19 protocols at the site [only at Screening]), or history of fever during the previous 24 hours (at least documented verbally). Weight: 5. Have a body weight ≥ 24 kg Merck Healthcare KGaA, Darmstadt, Germany an affiliate of Merck KGaA, Darmstadt, Germany Frankfurter Str. 250 64293, Darmstadt, Germany Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants.
REFNo: HS2646ES

The primary objective of this study is to confirm the dose of ATV/co or DRV/co in HIV-1 infected pediatric participants, to confirm the dose of F/TAF in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
 Mityana, Mityana
Mubende, Mubende
Masaka, Masaka
Rakai, Kalisizo
Kampala, Kampala
Wakiso, Entebbe
 Uganda 2023-03-09 23:33:04 2026-03-09 15 The study will be conducted in young children and adolescents aged 3 to < 18 years; HIV-1 infected on a stable antiretroviral regimen for a minimum of 3 months. In Uganda, the study will be conducted by researchers from the coordinating site, MU-JHU Research Collaboration, MU-JHU CARE – Kampala, Uganda, in collaboration with Africa Medical and Behavioral Sciences Organization (AMBSO) – Kampala and SICRA-TASO MULAGO National Referral Hospital, Masaka, Uganda. Gilead Sciences Inc Medical and Health Sciences Clinical Trial Non-degree Award
Raymond Tweheyo
ID: UNCST-2020-R014507
 Understanding the effect of varied financial compensation structure for improving the performance, motivation and retention of Community Health Workers in Uganda - a quasi experiment
REFNo: HS2689ES

General objective: To understand the effect of varied financial compensation structure for improving the performance, motivation and retention of Community Health Workers in Uganda.

Specific objectives:
1. To determine the optimal performance based financial incentive incentive's structure required for improving the performance, motivation and retention of CHWs.

2. To explore the acceptability and perceptions of potential sustainability of CHWs financial compensation structure to various stakeholders, including the CHWs, and the CHW supervisors at the district and Ministry of Health.

3. To explore the perceived value and impact of financial incentives on CHW's job satisfaction, personal income and livelihood.
 Wakiso, all parishes
Mpigi, all parishes
Mbale, all parishes
Jinja, all parishes
 UK 2023-03-07 10:40:31 2026-03-07 3,215 children under five, 720 Community Health Workers, 32 Key Informants 1. Women of reproductive age (18 to 49 years) who have a child under five years of age. 2. Community Health Workers (18 years and above) 3. Adult Key Informants - district, Ministry of Health and Implementing Partner officials USAID/ Living Goods Medical and Health Sciences Clinical Trial Non-degree Award
Rachel Brathwaite
ID:
Assessing the Feasibility of Economic Approaches to Prevention of Substance Abuse among Adolescents
REFNo: HS2683ES

Aim 1. Examine the prevalence and consequences of ADU in a cohort of 200 AYLHIV (ages 18-24) seen at six (6) HIV clinics in southwestern Uganda.
Aim 2. Using a mixed methods approach, identify the multi-level (individual, interpersonal, community and structural) factors associated with ADU among AYLHIV.
Aim 3. Using a subset of the sample, explore the feasibility and short-term effects of a family-based economic empowerment intervention on ADU among AYLHIV.

 Masaka,
Trinidad and Tobago 2023-03-02 15:32:31 2026-03-02 230 220 Adolescents and youths living with HIV aged 18-24 years. 10 healthcare providers aged >18 years. National Institute on Alcohol Abuse and Alcoholism Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
 PHASE 2C CLINICAL TRIAL OF NOVEL, SHORT-COURSE REGIMENS FOR THE TREATMENT OF PULMONARY TUBERCULOSIS: CRUSH-TB (Combination Regimens for Shortening TB Treatment)
REFNo: HS2650ES

Primary objective
(1) To compare the efficacy of each experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in liquid media.

Secondary objectives
(1) To compare the proportion of participants with a grade 3 or higher adverse event in each experimental arm with the control arm
(2) To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up to 52 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
(3) To compare the efficacy of each experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in solid media
(4) To compare the proportion of participants in each arm who convert liquid and solid sputum cultures to negative by (a) 8 weeks of treatment and (b) 12 weeks of treatment
(5) To describe the rate of all-cause study drug discontinuation in each arm
(6) To compare time to sputum culture positivity curves through 17 weeks in the Mycobacterial Growth Indicator Tube (Bactec MGIT960) across arms
(7) To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up up to 78 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
(8) To describe the population PK of bedaquiline and its M2 metabolite, with or without rifabutin co-administration (PK#1)
(9) To conduct pharmacokinetic/pharmacodynamics study of the test drugs to determine relationships between pharmacokinetic parameters (AUC, Cmax) and outcome measures (time to culture negativity or rate of change in TTP) using non-linear mixed effects models, adjusting for key covariates that may affect outcomes (e.g. companion drugs, HIV status, cavitary disease) (PK#2)

 Kampala, Mulago
 Uganda 2023-02-21 13:13:53 2026-02-21 288 overall, 100 in Uganda This will be a multisite international study. Male and female participants who are age 12 or older and have suspected or proven pulmonary tuberculosis will be enrolled into the study. Enrollment will be open to all TBTC sites willing to participate and who have completed trial start-up requirements. Target enrollment is at least 288 participants (96 participants per arm). Pregnant or breast-feeding individuals will be excluded from the study because of uncertainties about the safety of bedaquiline, delamanid, and moxifloxacin in these groups. The sex, ethnicity, and socioeconomic background of study participants are expected to mirror those of the populations served by local tuberculosis clinics and the populations most affected by tuberculosis worldwide. Co-enrollment in other therapeutic clinical trials is not allowed. U.S. Centers for Disease Control and Prevention Medical and Health Sciences Clinical Trial Non-degree Award
View Sort By:

Our Partners