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  
Miriam Nakalembe
ID: UNCST-2021-R014040
 A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS (BEATRIX)
REFNo: HS8109ES

To describe GBS serotype-specific IgG concentrations measured from dried blood spots in a subset of infant participants at birth; To describe anti-GBS antibodies present in breast milk in a subset of maternal participants vaccinated with GBS6 To describe serum IgG responses to active immunization with diphtheria toxoid�containing vaccine and PCV in infant participants born to maternal participants vaccinated with GBS6 versus placebo. To describe PCV serotype-specific OPA titers after a toddler vaccination in infant participants born to maternal participants vaccinated with GBS6 or placebo. To additionally describe the immune responses to CPS elicited by GBS6 when administered to healthy pregnant women. To describe serum IgG responses to active immunization with diphtheria toxoid� containing vaccine and/or PCV in infant participants born to maternal participants vaccinated with GBS6 versus placebo.,To further describe the immunogenicity of GBS6 in maternal participants when administered to healthy pregnant women. To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS EOD and LOD, separately, caused by the 6 individual vaccine serotypes (Ia, Ib, II, III, IV, and V) in infants when GBS6 is administered to healthy pregnant women,To assess the ability of GBS6 to induce opsonophagocytic activity (OPA) titers at birth in infant participants born to maternal participants vaccinated with GBS6,To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6. To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS disease (all disease) caused by the 6 individual vaccine serotypes in infants when GBS6 is administered to healthy pregnant women,To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS EOD based on serotype-specific anti-CPS IgG concentrations measured in infants at birth,To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS LOD based on serotype-specific anti-CPS IgG concentrations measured in infants at birth. To assess the ability of GBS6 to induce anti-CPS IgG antibody levels predicted to provide protection from invasive GBS early-onset disease (EOD) caused by the 6 individual vaccine serotypes (Ia, Ib, II III, IV, and V) in infants when GBS6 is administered to healthy pregnant women,To assess the ability of GBS6 to induce anti-CPS IgG antibody levels predicted to provide protection from invasive GBS late-onset disease (LOD) caused by the 6 individual vaccine serotypes (Ia, Ib, II III, IV, and V) in infants when GBS6 is administered to healthy pregnant women,To assess the safety of maternal immunization in infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy. To describe the safety and tolerability of GBS6 in maternal participants
 Kampala, Naguru
 Uganda 2026-07-17 17:00:50 2029-07-17 115-150 The study population will include pregnant women attending antenatal services at Naguru General Hospital and their infants after delivery. The study will enroll pregnant women who are healthy participants aged ≤49 years who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination and their infants, with an uncomplicated, singleton pregnancy, and who have no known increased risk of pregnancy complications Medical and Health Sciences Clinical Trial Non-degree Award
Abel  Kakuru
ID: UNCST-2022-R009193
 Perennial Malaria Chemoprevention With Dihydroartemisinin-Piperaquine Versus Sulfadoxine-Pyrimethamine Plus Amodiaquine Versus No Chemoprevention: A Double Blind Randomised Controlled Trial
REFNo: HS7437ES

1. To compare the protective efficacy of combining R21 vaccination with PMC-DP or PMC-SPAQ vs R21 alone up to 5 years of age.
2. To compare the safety and tolerability of combining R21 vaccination with PMC-DP vs. PMC-SPAQ.
3. To determine the impact of PMC on the drug resistance landscape and R21-specific immunogenicity and durability.

 Busia, TC
 Uganda 2026-07-16 20:29:47 2029-07-16 1290 HIV-uninfected infants HIV-uninfected infants DMID Funding Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssinabulya
ID: UNCST-2021-R004352
 An mHealth implementation strategy to address the syndemic of mental illness, hypertension, and HIV in Uganda. Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)
REFNo: HS7936ES

To evaluate the factors impacting sustained engagement in the adapted Medly Uganda,To assess the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) to improve mental health care cascade metrics. ,
 Kampala, Naguru
 Uganda 2026-07-16 19:31:27 2029-07-16 1500 The study population consists of patients who are 18 years and above, that are living with HIV and receiving ongoing care at one of the 3 participating sites in this research (n=1500). A subset of this population who also have hypertension will be enrolled in a longitudinal cohort (n=210). It is estimated that up to 25% of patients living with HIV have hypertension, so this is an achievable sample. We’ll also conduct qualitative interviews with healthcare workers and study participants in the intervention arm at the end of the trial. Medical and Health Sciences Clinical Trial Non-degree Award
Musa Sekikubo
ID: UNCST-2021-R014010
 A phase 3, randomized, placebo-controlled, double-blinded trial to evaluate the safety, tolerability, and immunogenicity of a multivalent Group B Streptococcus vaccine in healthy pregnant women and their infants.
REFNo: HS8122ES

To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS EOD based on serotype-specific anti-CPS IgG concentrations measured in infants at birth,To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS LOD based on serotype-specific anti-CPS IgG concentrations measured in infants at birth.,To assess the ability of GBS6 to induce anti-CPS IgG antibody levels predicted to provide protection from invasive GBS early-onset disease (EOD) caused by the 6 individual vaccine serotypes (Ia, Ib, II III, IV, and V) in infants when GBS6 is administered to healthy pregnant women.,To assess the ability of GBS6 to induce anti-CPS IgG antibody levels predicted to provide protection from invasive GBS late-onset disease (LOD) caused by the 6 individual vaccine serotypes (Ia, Ib, II III, IV, and V) in infants when GBS6 is administered to healthy pregnant women.,To assess the safety of maternal immunization in infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy.,To describe the safety and tolerability of GBS6 in maternal participants,
 Kampala, Kawempe
Uganda 2026-07-16 19:21:43 2029-07-16 150 Pregnant women aged 18 years and above in their 3rd trimester Medical and Health Sciences Clinical Trial Non-degree Award
Cristina Reverzani
ID: UNCST-2023-R008154
 Vitamin D supplementation among pregnant women in Uganda for the prevention of adverse obstetric outcomes: a randomized controlled trial
REFNo: HS7794ES

The objective of this trial is to investigate if vitamin D supplementation among pregnant women in Uganda prevents adverse maternal and foetal outcomes, with special emphasis on preeclampsia.
Italy 2026-06-25 22:39:41 2029-06-25 - Intervention group – 990 women will receive oral 2.000 IU vitamin D daily; or. - Control group – 990 women will receive an oral placebo daily. The target population of the present study will comprise pregnant women, attending ANC services in the gestational week from 13 to 27, who meet the eligibility criteria. The accessible population of the present study will comprise all the women attending ANC at Lacor Hospital during the study period, who meet the eligibility criteria. Pregnant women, attending ANC services in the gestational week from 13 to 27, confirmed by ultrasonography, will receive oral and written information about the trial by a member of the research group, and will be invited to participate in the trial. Those who agree to participate will give informed consent, in agreement with the Declaration of Helsinki. The study population of the present research will not include special or vulnerable subjects such as minors, prisoners and mentally handicapped subjects. Medical and Health Sciences Clinical Trial Non-degree Award
Pauline Byakika-Kibwika
ID: UNCST-2019-R001206
 Platform Adaptive Randomised Trial for NEw and Repurposed Filovirus treatmentS
REFNo: HS7849ES

To evaluate the impact of potential treatments on mortality in patients with filovirus disease. ,
 Uganda 2026-06-08 21:31:41 2029-06-08 0 All patients with Ebola, all age, all sex is included Medical and Health Sciences Clinical Trial Non-degree Award
NSUBUGA GERALD
ID: UNCST-2021-R011633
 Feasibility and Acceptability Using Umbilical Cord Blood for Cancer Treatment through Stem Cell Transplantation: A Multi-Center Study Involving Pregnant Mothers, Health Workers, and Cancer Patients in Collaboration with the Uganda Blood Transfusion Service
REFNo: HS6131ES

General Objective To assess the feasibility and acceptability of collecting and using umbilical cord blood for stem cell transplantation in cancer patients based on the perceptions and readiness of pregnant mothers, health professionals, and cancer patients in selected public health facilities in Uganda. Specific Objectives 1. To determine the level of awareness and knowledge about umbilical cord blood stem cell transplantation among pregnant mothers, health professionals, and cancer patients. 2. To assess the willingness of pregnant mothers to donate umbilical cord blood for therapeutic use. 3. To evaluate the preparedness of health professionals to support UCB collection, processing, and utilization.
Kampala,
Wakiso,
Uganda 2026-06-05 15:35:56 2029-06-05 385 The study population will comprise diverse groups of individuals relevant to the establishment of an umbilical cord blood bank for allogeneic stem cell transplantation at Uganda Blood Transfusion Service (UBTS). Expectant Mothers: Pregnant women aged 18 to 45 years attending antenatal clinics at selected hospitals will form the primary group. This age range represents women of reproductive age with the potential to donate umbilical cord blood. Expectant mothers from different tribes and ethnic backgrounds across Uganda will be included to ensure diversity and representativeness. Healthcare Providers: Participants will include medical doctors, nurses, midwives, and laboratory personnel involved in maternal and child health, blood banking, and oncology services. Their insights will be critical in understanding technical and operational needs. Both male and female providers will be included, with no age restrictions, focusing on those actively working in relevant departments. UBTS Staff and Policymakers: Staff from UBTS, including management and technical personnel, as well as policymakers from the Ministry of Health, will participate to provide perspectives on regulatory, logistical, and financial requirements. Community Representatives: Community leaders and opinion leaders from various regions and ethnic groups will also be engaged to capture cultural attitudes and perceptions about umbilical cord blood donation. Government of Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Namulema Edith
ID:
Exploring the feasibility and safety of using the ‘LeVe Neonatal CPAP System’ to assist neonates with signs of respiratory distress at Mengo Hospital
REFNo: HS7747ES

1) Feasibility Objective - To determine the proportion of neonates in whom the LeVe CPAP device can be successfully initiated and maintained for the entire study duration.
2) Safety Objective - To determine the incidence of CPAP-related adverse events occurring within the first 7 days of CPAP therapy.
3) Respiratory Effectiveness Objective - To assess the early respiratory response to CPAP within 2 hours of initiation and for the entire study duration using SpO?, FiO? measures and the Silverman-Andersen respiratory distress score.
4) Prematurity-Related Outcome Objective - To determine the incidence of survival to discharge, bronchopulmonary dysplasia, and retinopathy of prematurity.
5) To explore healthcare workers' perceptions and experiences regarding CPAP training adequacy, their confidence in using neonatal CPAP, and their views on how CPAP implementation influences neonatal respiratory outcomes within their clinical setting

 Kampala, Mengo
 Uganda 2026-05-28 16:35:26 2029-05-28 40 Neonates Age: 0–28 days of life. University of Leeds Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 A Phase I/II clinical study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ITU512 in healthy participants and patients with sickle cell disease
REFNo: HS6925ES

1.To assess the safety and tolerability
of ITU512 in healthy participants
2.To assess the safety and tolerability
of ITU512 in participants with SCD
3.To assess the effect of ITU512 on
fetal hemoglobin expression

 Wakiso, Sabagabo
 Uganda 2026-05-22 16:52:18 2029-05-22 89 children, adults, mela and female Norvatis Medical and Health Sciences Clinical Trial Non-degree Award
Elizabeth Kaudha
ID: UNCST-2025-R017151
 A Phase 3b, open-label, multicenter, continued access study for participants transitioning from ViiV Healthcare-sponsored or ViiV Healthcare collaborative parent studies for HIV treatment.
REFNo: HS7588ES

The main objective of the study is to provide continued access to study interventions for participants who were enrolled and treated in ViiV Healthcare-sponsored or ViiV Healthcare-collaborative parent studies and who continue to experience clinical benefit, and to describe the continued use and safety of the study intervention. The specific objectives of this study are, Reasons for discontinuation of study intervention Incidence and outcome of serious adverse events (SAEs) Incidence and outcome of adverse events of special interest (AESIs)
 Kampala, Mulago II Parish
Wakiso, Lubowa Parish
Kampala, Kansanga parish
 Uganda 2026-05-15 18:55:49 2029-05-15 130 Participants eligible for this study are individuals with HIV-1 who received the study intervention and completed the protocol-defined treatment period in ViiV Healthcare-sponsored or ViiV Healthcare-collaborative parent studies, and who, at the time of transition to this continued access study, experience clinical benefit as determined by the Investigator of Record from the parent study intervention ViiV Healthcare UK Limited, 79 New Oxford Street, London, WC1A 1DG, United Kingdom Medical and Health Sciences Clinical Trial Non-degree Award
Crispus Natwijuka
ID: UNCST-2024-R016280
 TESTING NRIMS VERSION 2
REFNo: SIR729ES

testing testing testing
 Uganda 2026-05-06 10:30:12 2029-05-06 24 testing testing Engineering and Technology Clinical Trial Non-degree Award
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
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