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 |
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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 |
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|
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 |
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