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  
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
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
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
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
Catriona  Waitt John
ID: UNCST-2019-R001068
Implementation of a "bundle of care" to improve anticoagulation control in patients receiving warfarin in Uganda and South Africa
REFNo: HS1422ES

Primary objective is to evaluate whether implementation of warfarin bundle improves time in therapeutic range

Secondary objectives are:
-To evaluate whether implementation of the warfarin bundle improves time to achieving a therapeutic INR
-Whether implementation of the warfarin bundle affects the occurrence of adverse events(death, bleeding and thrombotic events)
-whether staff find the interventions contained in the bundle acceptable
-To explore patients' experiences and acceptability of the package of care, and
-Whether the bundle represents good value for money
Kampala, Salaama
Kampala, Mulago
UK 2021-07-09 2024-07-09 444 Adult patients (18 years or older),male or female newly initiated on warfarin for the first time University of Liverpool Medical and Health Sciences Clinical Trial Non-degree Award
Jayne Ellis
ID: UNCST-2021-R013987
“Integrated management of cryptococcal and opportunistic infections to improve outcomes in advanced HIV disease (IMPROVE study)”
REFNo: HS1607ES

1) To generate evidence on the safety (adverse events) and feasibility (adherence and tolerability) of 1HP (one month of isoniazid and rifapentine) for TB preventative therapy (TPT) amongst adults with HIV-associated cryptococcal meningitis.
2) To generate preliminary data on potential secondary benefits (reduced loss to follow-up, reduced active TB disease, reduced mortality due to TB) of early (inpatient initiation) 1HP TPT as compared to standard (outpatient initiation) 1HP TPT amongst adults with HIV-associated cryptococcal meningitis.

Kampala, Salaama
Mbarara, Mbarara
UK 2021-08-25 2024-08-25 205 Adults (>18 years) with HIV-associated cryptococcal meningitis London School Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Degree Award
Raymond Tweheyo
ID: UNCST-2020-R014507
Evaluating the pilot of the Community Health Extension Worker (CHEW) strategy in Uganda: assessing feasibility, and effectiveness for improving Village Health Team (VHT) supervision and reporting
REFNo: HS2545ES

General Objective
To explore the acceptability, document the implementation process and evaluate the effectiveness of the Community Health Extension Worker strategy in two districts of Uganda to guide improving the community health system

Specific Objectives
1) To assess the acceptability of introducing a Community Health Extension Worker (CHEW) strategy in a district health system.

2)To document the process of setting up and implementing a Community Health Extension
Worker (CHEW) strategy within a district health system.

3) To estimate the program costs and duration for setting up a government-led Community Health Extension Worker (CHEW) strategy within a district health system.

4) To determine the effectiveness of the CHEW strategy for improving the quality of Village Health Team (VHT) member’s supervision and reporting in a district health system.

5) To assess the effect of the CHEW strategy on community-level indicators: completion of four antenatal care visits, skilled delivery attendance, fully immunized under-fives, and U5 sick children seen by VHTs and treated within 24 hours.

Mayuge, all parishes
Lira, all parishes
Kabarole, all parishes
Kyotera, all parishes
UK 2023-01-03 13:08:01 2026-01-03 3,016 women of reproductive age 1) Household members: Adult women of reproductive age 18 to 49 years. 2) Community health workers - 18 years and above 3) Health facility workers - 18 years and above 4) District technical and political leaders - 18 years and above 5) Community Health Implementing partners - adults, 18 years and above USAID/ Uganda Health Systems Strengthening Activity (UHSS) Medical and Health Sciences Clinical Trial Non-degree Award
Kathy Burgoine
ID: UNCST-2022-R011521
Impact of prophylactic Continuous Positive Airway Pressure in the Delivery Room (DR-CPAP) on neonates <1500g in a low-resource setting: A feasibility trial
REFNo: HS2605ES

- To determine the acceptability of DR-CPAP to healthcare workers in a low-resource setting - To determine the post-intervention acceptability of using a two-stage consent process in neonatal emergencies in the delivery room in this setting - To evaluate the feasibility of a third-party allocation process for randomisation by determining the time to randomization - To evaluate feasibility of initiating DR-CPAP in a low-resource setting in infants with birthweight 800-1500g within 15 minutes of delivery - To determine the safety of initiating DR-CPAP in a low-resource setting - To estimate the sample size to be used for future evaluation in the full trial - To assess the feasibility of secondary outcome measures to be used in the full trial
Mbale,
UK 2023-02-02 12:18:23 2026-02-02 100 The study population will be inborn preterm infants with a birthweight of 800g to less than 1500g who are spontaneously breathing at 5 minutes of life. They will be recruited within 15 minutes of birth and followed up until death or 28 days. Both male and female infants will be included. Mbale Clinical Research Institute (MCRI) Medical and Health Sciences Clinical Trial Non-degree Award
Raymond Tweheyo
ID: UNCST-2020-R014507
Understanding the effect of varied financial compensation structure for improving the performance, motivation and retention of Community Health Workers in Uganda - a quasi experiment
REFNo: HS2689ES

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

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

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

3. To explore the perceived value and impact of financial incentives on CHW's job satisfaction, personal income and livelihood.
Wakiso, all parishes
Mpigi, all parishes
Mbale, all parishes
Jinja, all parishes
UK 2023-03-07 10:40:31 2026-03-07 3,215 children under five, 720 Community Health Workers, 32 Key Informants 1. Women of reproductive age (18 to 49 years) who have a child under five years of age. 2. Community Health Workers (18 years and above) 3. Adult Key Informants - district, Ministry of Health and Implementing Partner officials USAID/ Living Goods Medical and Health Sciences Clinical Trial Non-degree Award
Moses Oketch
ID: UNCST-2024-R004313
Long-Term Impacts of Improved Childhood Literacy
REFNo: SS2796ES

Economic situation,
Amolatar,
Dokolo,
UK 2024-08-05 14:01:33 2027-08-05 6581 Former participants of a study on the impact of an early-grade literacy intervention. The study was implemented from 2009 to 2011. The respondents are aged between 19 and 24 years old, with an average age of 21 years. Center for Global Development Social Science and Humanities Clinical Trial Non-degree Award
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
Lisa Hartwig
ID:
The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
REFNo: HS2194ES

To assess the effectiveness of a behavioral intervention designed to encourage financial savings for healthcare costs and birth preparedness among pregnant women and their partners in Uganda. To examine whether increased earmarked financial savings for healthcare costs leads to increased utilization of maternal health services and male involvement in maternal healthcare.
Kyotera, All
USA 2022-05-23 9:28:49 2025-05-23 700 To be eligible for joining the study, the participants must fulfill the following eligibility criteria: (1) 18-49 years old, (2) Between 12-32 gestational weeks (pregnant female) OR partner of someone who is (male), (3) Own a mobile phone, (4) Has a regis The University of Tokyo Medical and Health Sciences Clinical Trial Degree Award
Thomas McHale
ID: UNCST-2022-R008812
Optimizing the Dose of Flucytosine for Cryptococcal Meningitis
REFNo: HS2940ES

Determine if 50 mg/kg/day of 5-FC has a similar mortality benefit compared to 100 mg/kg/day,Reduce the cost and supply burden of treating an individual with cryptococcal meningitis,Determine if 50 mg/kg/day of 5-FC is a safer dosage compared to 100 mg/kg/day of 5-FC,Determine if 50 mg/kg/day of 5-FC is has a similar rate of cryptococcal clearance from CSF compared to 100 mg/kg/day,Determine the optimal dose of 5-FC for for management of induction phase of therapy for cryptococcal meningitis,
Kampala,
Mbarara,
USA 2023-07-05 11:41:24 2026-07-05 The target sample size is 50 participants The study will enroll adults with HIV who are over 18 years old and sick with cryptococcal meningitis. National Institute of Health, United States Medical and Health Sciences Clinical Trial Degree Award
Sarah Lofgren
ID: UNCST-2019-R001647
Supervised Treadmill intervention to Reduce Inflammation and Depression through Exercise in HIV: The STRIDE Pilot Study
REFNo: HS3358ES

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

3.2 Secondary Endpoint(s)/ Outcome(s):
- acceptability of the intervention assessed via a post intervention survey
-feasibility and acceptability of using a wearable exercise tracker to assess the volume of exercise, based on calories burned and steps achieved, during the intervention period among Ugandans with HIV and depression.
- measure the mean and standard deviation of baseline and 8-week serum BDNF and IL-6 level to estimate an effect size and power a future study.
- measure the mean and standard deviation of baseline and 8-week depression score via PHQ-9 to estimate an effect size and power a future study.
- measure the mean and standard deviation in aerobic fitness baseline and at 8 weeks measured via METS/watts achieved and total time/distance to estimate the effect size for a future intervention.
Wakiso, Lweeza
USA 2024-02-26 13:41:23 2027-02-26 24 • Enrolled in Mildmay HIV clinic • Adults 18-45 years old • HIV positive • Receiving HIV therapy • HIV viral suppression (<400 copies/mL) per chart review • Mild to Moderate (PHQ9 score >5 but >20) • Not currently engaged in a formal exercise program or manual labor such as construction or delivery requiring a manual bike or walking • Able to walk/run on a treadmill • Informed consent University of Minnesota, Makerere University Medical and Health Sciences Clinical Trial Non-degree Award
Schola  Matovu Nakachwa
ID: UNCST-2022-R011040
Development and Testing of BAJJAJJA: An Intervention to Promote Economic Empowerment and Health of Grandmothers who Provide Primary Care for Grandchildren in Uganda
REFNo: SS3611ES

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

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

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