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).
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Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
Francis Ssali
ID: UNCST-2021-R012134
 A5424 Menopausal Hormone Therapy for Women Living with HIV (HoT)
REFNo: HS7391ES


1.2 Primary Objective

1.2.1 Determine the effects of HT on VMS in WLWH in the late menopausal transition or early postmenopause.

1.3 Secondary Objectives

1.3.1 Evaluate the safety and tolerability of HT as compared to placebo.

1.3.2 Determine the effect of HT on neurocognition.

1.3.3 Determine the effect of HT on mood.

1.3.4 Determine the effect of HT on sleep.

1.3.5 Determine the effect of HT on quality of life.

1.3.6 Determine the effect of HT on sexual function.

1.3.7 Determine the effect of HT on weight, waist circumference, and waist-to-hip ratio.

1.4 Exploratory Objectives

1.4.1 Determine the effect of HT on markers of bone turnover.

1.4.2 Determine the effect of HT on markers of cardiometabolic health.

1.4.3 Determine the effect of HT on systemic markers of inflammation and immune activation.

1.4.4 Determine the effect of HT on HIV reservoir size, clonality, and activity.

1.4.5 Determine the effect of HT on measures of physical function.

1.4.6 Determine the effect of HT on the rectal and vaginal microbiome.

1.4.7 Explore the effect of HT on all primary and secondary outcomes by antiretroviral regimen.

1.4.8 Explore exposure-response relationships between estradiol pharmacokinetics (PK) and study outcomes in those treated with estradiol.

1.4.9 Evaluate acceptability and feasibility of ambulatory monitors for VMS and sleep on a subset of participants.

1.4.10 Explore agreement between subjective VMS frequency with objective VMS frequency in a subset of participants.


 Kampala, Seguku
 Uganda 2026-04-24 13:20:15 2029-04-24 96 40-60 YEARS OLD WOMEN LIVING WITH HIV/AIDS. ENGLISH AND LUGANDA UNDERSTANDING PARTICIPANTS National Institute of Allergy and Infectious Diseases Medical and Health Sciences Clinical Trial Non-degree Award
Yudaya Nakyeyune
ID: UNCST-2026-R024597
 Using Play in Culturally Responsive Ways to Enhance Children’s Numeracy Skills Achievement in Refugee-Hosting ECD Centers in Kampala
REFNo: SS5116ES

1. To analyze children's voices of learning through play in refugee hosting ECD centers in Kampala.
2. To identify the challenges teachers encounter when using play in the teaching of numeracy in refugee hosting ECD centers in Kampala
3 To establish the impact of engagement in Continuing Professional Development (CPD) on teachers' knowledge regarding the use of play-based methods in culturally responsive ways in refugee hosting ECD centers in Kampala
4. To assess the impact of engagement in culturally responsive learning through play activities on children's numeracy achievement in refugee hosting ECD venters in Kampala
Kampala, Makerere
 Uganda 2026-04-20 16:47:28 2029-04-20 264 The study sample will consist of eight centers, 24 teachers (three per center), and 480 children (60 per center; 240 children in each arm). Within each center, three P1–P3 classes, each with approximately 20 children, participate. Randomization will be stratified based on center characteristics, specifically the proportion of refugee children (high or low), and will be conducted using computer-generated random numbers. Self Sponsored Social Science and Humanities Clinical Trial Degree Award
Fred Kigozi
ID: UNCST-2025-R021423
 Postprandial effect of isocaloric challenge meals enriched with indigenous fruits and vegetables on glucose metabolism in individuals with type 2 diabetes in Wakiso District, Uganda.
REFNo: HS7347ES

General Objective To evaluate the postprandial effect of isocaloric challenge meals enriched with indigenous fruits and vegetables on glucose metabolism among people living with type 2 diabetes in Wakiso district, Uganda. Specific Objectives 1.To assess the acute postprandial effects of isocaloric challenge meals enriched with indigenous fruits and vegetables on incremental area under the curve (iAUC) blood glucose levels. 2.To assess the acute postprandial effects of isocaloric challenge meals enriched with indigenous fruits and vegetables on iAUC blood triglyceride levels.
Wakiso, Kitende
 Uganda 2026-04-20 10:47:24 2029-04-20 8 People living with type 2 diabetes aged 30-60 years 1 Medical and Health Sciences Clinical Trial Degree Award
William Worodria Ofuti
ID: UNCST-2022-R010915
 Program for Rifampicin-Resistant Disease with Stratified Medicine for TB” (PRISM-TB)
REFNo: HS7398ES

To identify, among participants with fluoroquinolone-susceptible multidrug-resistant/rifampicin-resistant tuberculosis (FQ-S MDR/RR-TB), the preferred BPaLM strategy of 13 or 17 weeks for participants stratified to receive shorter treatment and 17 or 24 weeks for participants stratified to receive longer treatment, as defined by a prespecified stratification algorithm, and to evaluate whether this BPaLM strategy has noninferior efficacy to the control strategy at Week 73.

1. To evaluate whether a BPaLM strategy of 17 weeks for participants stratified to receive shorter treatment and 24 weeks for participants stratified to receive longer treatment, as defined by a prespecified stratification algorithm, has superior DOOR probability to the control strategy combining efficacy at the end of follow-up (a minimum of 28 weeks post-randomization) and safety at 28 weeks post-randomization.
2. To evaluate whether a BPaLM strategy of 17 weeks for all participants has superior DOOR probability to the control strategy combining efficacy at the end of follow-up (a minimum of 28 weeks post-randomization) and safety at 28 weeks post-randomization.
3. To evaluate whether a BPaLM strategy of 13 weeks for participants stratified to receive shorter treatment and 24 weeks for participants stratified to receive longer treatment, as defined by a prespecified stratification algorithm, has superior DOOR probability to the control strategy combining efficacy at the end of follow-up (a minimum of 28 weeks post-randomization) and safety at 28 weeks post-randomization.
4. To evaluate whether a BPaLM strategy of 13 weeks for participants stratified to receive shorter treatment and 17 weeks for participants stratified to receive longer treatment, as defined by a prespecified stratification algorithm, has superior DOOR probability to the control strategy combining efficacy at the end of follow-up (a minimum of 28 weeks post-randomization) and safety at 28 weeks post-randomization.
5. To compare the proportion of participants who experience grade 3 or higher adverse events by Week 28 in the preferred BPaLM strategy to the control strategy.
6. To compare the proportion of participants who experience adverse events of special interest by Week 28 in the preferred BPaLM strategy to the control strategy.
7. To compare the proportion of participants who experience a TB-related unfavorable outcome at Week 73 on the preferred BPaLM strategy with the control strategy, among participants stratified to receive shorter treatment.
8. To compare the proportion of participants who experience a TB-related unfavorable outcome at Week 73 on the preferred BPaLM strategy with the control strategy, among participants stratified to receive longer treatment.
9. To evaluate the pharmacokinetics of all drugs in the BPaLM regimen with an additional focus on bedaquiline elimination (Stages 1 and 2).
10. To determine the dose-response and exposure-response relationships between study drug estimated PK parameters with efficacy and toxicity (Stages 1 and 2).
11. To evaluate the feasibility and acceptability of treatment stratification in the context of treatment for MDR/RR-TB from the participant and the health system perspective (Stages 1 and 2).
 Kampala,
Uganda 2026-04-10 18:15:27 2029-04-10 60 All SMART TB Medical and Health Sciences Clinical Trial Non-degree Award
Richard Idro
ID: UNCST-2021-R013599
 Dihydroartemisinin-piperaquine for the post-discharge management of children with severe acute malnutrition in Malawi and Uganda; A multicentre, parallel-group, two-arm, randomised, double-blind superiority trial [Short Title: Post-discharge Malaria Chemoprevention - SAM (PDMC-SAM)]
REFNo: HS7291ES

To determine if 4 months of PDMC with dihydroartemisinin piperaquine (DP) compared to placebo is superior in reducing hospital readmissions and death by 6 months in children aged <5 years admitted with ‘SAM’ who are clinically stable and ready to be discharged to OTC.,
 Jinja, Nalufenya
 Uganda 2026-04-10 18:06:21 2029-04-10 Overall 560, about 300 in Uganda Children, aged <5 years, with severe acute malnutrition [defined as weight-for-height <-3 SD-score or mid-upper circumference <115 mm, or symmetrical pitting oedema], discharged through/attending Outpatient Therapeutic care (OTC) clinics. Training and Research Unit of Excellence, Blantyre, Malawi Medical and Health Sciences Clinical Trial Non-degree Award
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
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