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  
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
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