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  
Nelson Sewankambo K
ID: UNCST-2020-R014578
Evaluation of an Information Management and Communication System for Population-wide Point-of-Care Infant Sickle Cell Disease Screening (SIMCS)- A Cluster Randomized Trial
REFNo: HS6567ES

(ii) To evaluate the impact of the SCD SIMCS on access to screening and care and outcomes of children with SCD,
Jinja, Kakindu
Iganga,
Mayuge,
Kayunga,
Uganda 2025-12-05 18:30:02 2028-12-05 60 Health centers Infants aged 4-6 months National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
Safety, preliminary efficacy, and Pharmacokinetics of Herbal/Natural/ Traditional therapeutic products for the management of Diabetes Mellitus in Uganda.
REFNo: HS6530ES

Main Objective
1. To evaluate the safety, effectiveness and pharmacokinetics of 3 selected NDA- notified herbal/natural/traditional therapeutic products in Uganda, designated IMP1, IMP2, and IMP3.
2. To explore the experiences of innovators, researchers, implementers, and participants involved in this study on the innovation and scientific evaluation of natural therapeutics in Uganda.

Specific Objectives
1. To determine the efficacy of selected NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the treatment of diabetes mellitus in adult patients in Uganda
2. 2. To assess the effect of the selected NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) on specific cardio-metabolic characteristics of adult patients with DM in Uganda.
3. To assess clinical and laboratory adverse events associated with selected NDA- notified herbal/natural/traditional therapeutic products, specifically IMP1, IMP2 and IMP3 in adult patients with DM in Uganda.
4. To investigate the pharmacokinetic profile(s) of NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the management of DM.
5. To explore the experiences of innovators, researchers, implementers, and participants involved in this study on the innovation and scientific evaluation of herbal/natural/traditional therapeutics in Uganda.e the pharmacokinetic profile(s) of NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the management of DM.

Uganda 2025-12-01 14:19:22 2028-12-01 424 Objective 1- 4 Persons with a new or known diagnosis of diabetes mellitus Objective 5 Personnel working in research programs, including: Investigators, Program managers, Clinical staff Innovators of herbal/natural/ traditional therapeutic products purposed for diabetes mellitus management. Objective 1-4 Adult (≥18 years) patients with recently diagnosed diabetes mellitus (diagnosis made in the preceding three months) Objective 5 Individuals who have worked with the CONAT program as investigators, program manager, or clinical staff for at least six months. Innovators of herbal/natural/ traditional products for diabetes mellitus whose product will be found during the survey. Government of Uganda-STI-OP Medical and Health Sciences Clinical Trial Non-degree Award
Sarah Wilker
ID: UNCST-2025-R019791
One size fits all? Towards individual prediction of treatment success for posttraumatic stress disorder in post-conflict settings (TRAUMA-FIT)
REFNo: HS6712ES

Main Objective 1. to identify individual predictors of treatment response to two different treatments in survivors with PTSD in a post-conflict setting Specific Objectives 1. Investigate whether NET is, on average, more effective than PM+ for the treatment of PTSD 2. Identify predictors of optimal response in the two conditions, and thereby identify predictors of treatment success in a trauma-focused versus present-focused treatment 3. Investigate the explanatory role of socio-ecological factors in PTSD treatment response
Gulu,
Germany 2025-11-26 14:28:24 2028-11-26 660 (1) Adults of Age between 18 and 65; men and women, Acholi tribe (2) Survivor of trauma related to the LRA conflict or ongoing violence in the post-conflict setting; and (3) Probable diagnosis of PTSD according to DSM-5 (PSSI-5). German Research Foundation Medical and Health Sciences Clinical Trial Degree Award
MALLON TUSUUBIRA
ID: UNCST-2025-R021850
SURVEY ON PARATUBERCULOSIS IN SLAUGHTERED GOATS AT KAMPALA CITY ABATTIOR
REFNo: A654ES

General objective
To establish the prevalence of Mycobacterium avium subsp. paratuberculosis infection in goats
Specific Objectives
i. To determine the prevalence of the gross and microscopic lesions associated with paratuberculosis in the ileocecal junction and associated lymph nodes of goats slaughtered at Kampala city abattoir
ii. To establish the prevalence of Mycobacterium avium sub species paratuberculosis in suspected cases using polymerase chain reaction (PCR)

Wakiso, Kampala
Uganda 2025-11-21 14:36:09 2028-11-21 The sample size required will be calculated by using the formula of the estimation of prevalence in a population (Thrusfield et al., 2018). n = Z².p.(1-p)/d² Where: • n = sample size required • Z = Z-value (1.96 at a 95% confidence interval) • p = expected prevalence (According to standard epidemiologic practices 50% will be used since the prevalence is unknown). (Thrusfield, 2018; Dohoo et al,2009) • d = precision (5%) n = 1.96².0.5. (1-0.5)/0.05² = 384 The samples will be obtained from Kampala city Abattoir, a large goat slaughter house along the old Port Bell Road. The samples will be analysed in the histopathology research laboratory (CDL) and the pathology Laboratory, SVAR Makerere University. The study population will be goats that are brought to the abattoir for slaughter. The goats are from different parts of Uganda, with the majority coming from central and western Uganda. They will be offering a representative population to study the prevalence and incidence of paratuberculosis. The target population will be all the slaughtered goats at the abattoir during the study period. Self sponsored Agricultural Sciences Clinical Trial Degree Award
Martin Origa Jobson Ariel
ID: UNCST-2022-R010809
Validation of cervical cancer screening methods in Uganda: The National Cancer Management and Capacity building Project in Uganda (CANCAP UG) experience.
REFNo: HS6635ES

To assess multiple screening methods: VIA, PAP smear, HPV, and colposcopy, plus or minus biopsy.,To evaluate the indicators of screening accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of Visual Inspection with Acetic acid (VIA) test by comparing with the gold standard of disease status confirmed via histological results.,
Mbarara, cities
Mbarara, cities
Kampala, mulago
Kampala, kisenyi
Uganda 2025-11-21 14:33:45 2028-11-21 4000 All women, 25 years old meeting the inclusion criteria and attending the screening clinic at CANCAP sites uganda cancer insitute Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Mukonzo
ID: UNCST-2021-R013916
Safety of COVIDEX™ Therapy in adults: in Uganda: A randomized controlled open- label phase 1 clinical trial.
REFNo: HS6540ES

Overall aim
To validate the safety of COVIDEX™ therapy in adult Ugandans.

Specific objectives
Primary objective
To evaluate and document adverse events associated with COVIDEX™ among adults
in Uganda.

Secondary objective:
To determine the plasma concentration of berberine in adults receiving COVIDEX™ at
three different dose levels.
Kampala,
Uganda 2025-11-21 14:11:01 2028-11-21 72 Study participants shall be healthy adult volunteers of 18years and above JENA HERBALS LIMITED Medical and Health Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women
REFNo: HS6565ES

To evaluate the efficacy of MK-8527 qm compared to FTC/TDF qd for the prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections To evaluate the safety and tolerability of MK-8527 qm compared to FTC/TDF qd.
Masaka, Masaka
Uganda 2025-11-21 11:18:30 2028-11-21 150 This study includes participants of varying age, race, ethnicity, and sex, female at birth, Aged from 16 years to 30 years of age inclusive, at the time of providing the informed consent or assent and Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during screening. Merck Sharp & Dohme LLC Medical and Health Sciences Clinical Trial Non-degree Award
ERIC WOBUDEYA
ID: UNCST-2019-R001047
Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined with Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age with and without HIV
REFNo: HS6555ES

Primary Objectives
Cohort 1 and Cohort 2
• To determine the weight-band dosing of RPT taken as part of the 1HP regimen by evaluating:
⎯ PK RPT exposures among children with and without HIV
⎯ Safety and tolerability of the 1HP regimen among children with HIV while receiving twice-daily DTG and children without HIV through 28 days of dosing
Cohort 2
• To evaluate the effect of RPT taken as part of the 1HP regimen on the PK of DTG
Secondary Objectives
Cohort 1 and Cohort 2
• To evaluate the effect of covariates including age, weight, sex, ethnicity, nutritional status, and HIV-1 status on the PK of RPT taken as part of the 1HP regimen
• To evaluate the safety of the 1HP regimen through 24 weeks of follow-up
• To evaluate the palatability and acceptability of the 1HP regimen
• To evaluate adherence to the 1HP regimen
Cohort 2
• To evaluate the safety and tolerability of twice-daily DTG through 42 days among children with HIV who are receiving 1HP
• To evaluate virologic control (less than 200 copies/mL) at Day 42 among children taking a DTG-based ARV treatment regimen co-administered with 1HP

Kampala, mulago
Uganda 2025-11-04 12:59:17 2028-11-04 40 children living without HIV (Cohort 1) and children living with HIV (Cohort 2) at risk of TB disease who are less than 13 years of age. National Institute of Allergy and Infectious Diseases Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute of Mental Health Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
A5402 An Open-Label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV
REFNo: HS6604ES

1.2 Primary Objectives

1.2.1 To compare pramipexole to escitalopram in the treatment of MDD (and comorbid MDD with MND) based on the Beck Depression Inventory-II (BDI-II/BDI-2) total score [Beck 1996] from baseline to week 24.

1.2.2 To evaluate the safety of pramipexole and escitalopram in PWH having MDD (and comorbid MDD with MND) from baseline to week 24.

1.3 Secondary Objectives

1.3.1 To compare pramipexole to escitalopram in the treatment of MDD using MDD caseness, neurocognitive outcomes, and functional status from baseline to week 24.

1.3.2 To compare the depression, neurocognitive, and functional status outcomes in PWH with MDD alone and with comorbid MDD with MND treated with pramipexole versus escitalopram from baseline to week 24.

1.3.3 To compare the impact of pramipexole and escitalopram on all outcomes above by female versus male sex (assigned at birth) from baseline to week 24.

1.3.4 To determine the impact of pramipexole compared to escitalopram on the measure of HIV-1 RNA viral load in the peripheral blood.

1.4 Exploratory Objectives

1.4.1 To characterize associations between escitalopram trough concentrations and treatment efficacy (BDI-II/BDI-2 total score) as well as participant adverse events (adverse event frequency, severity, and discontinuation rates).

1.4.2 To characterize associations between escitalopram trough concentrations and genetic polymorphisms that affect metabolizing enzymes of escitalopram (known metabolizing enzymes include CYP2C19, CYP2D6, and CYP3A4).

1.4.3 To explore associations between cerebrospinal fluid (CSF) concentrations of escitalopram and BDI-II/BDI-2 total score.

1.4.4 To evaluate adverse events potentially related to drug interactions between antiretroviral therapy (ART) and escitalopram and pramipexole, respectively.

1.5 Substudy Objective

1.5.1 CSF Substudy

To compare the impact of pramipexole and escitalopram on biomarker outcomes in a CSF substudy of participants with MDD alone.

Uganda 2025-10-29 16:04:25 2028-10-29 50 PWH having a diagnosis of MDD alone or with comorbid MDD and MND · ≥18 to ≤70 years old both male and female. People who understand English and Luganda because the site informed consent forms only in Luganda and English National Institute of Allergy and Infectious Diseases and CIPLA Medical and Health Sciences Clinical Trial Non-degree Award
Abel  Kakuru
ID: UNCST-2022-R009193
Dihydroartemisinin-piperaquine plus sulfadoxine-pyrimethamine versus sulfadoxine-pyrimethamine alone for the prevention of febrile illnesses in children with sickle cell anemia: a double-blind randomized controlled trial
REFNo: HS6294ES

1.
To compare the incidence of all-cause febrile illness among children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
2.
To compare the incidence of adverse events among children with sickle cell anemia randomised to receive monthly SP vs. monthly DP+SP.
3.
To compare the prevalence of markers of antimalarial resistance, including those associated with SP and DP resistance, among parasitemic children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
Busia, Selected parishes
Uganda 2025-10-29 15:55:44 2028-10-29 232 children with sickle cell anemia Aged 2-10 years children with sickle cell anemia Thrasher Research Fund Medical and Health Sciences Clinical Trial Non-degree Award
Kyambadde Ronald
ID: UNCST-2025-R016678
HIGH DOSE VS STANDARD DOSE CAFFEINE THERAPY FOR APNEA OF PREMATURITY: A RANDOMISED CONTROL TRIAL.
REFNo: HS5776ES

To compare the efficacy and safety of high-dose caffeine citrate (loading dose 40 mg/kg/day, and maintenance of 20mg/kg/day), versus standard dose (loading dose of 20 mg/kg/day, maintenance of 10mg/kg/day), in preventing the occurrence and reducing the frequency of apneas among preterm infants ≤ 34 weeks’ gestation with Apnea Of Prematurity in the first 7 days of life.


Specific Objectives

1. To determine the effect of high dose compared to standard dose of caffeine on the incidence of apnea of prematurity among preterm babies at St. Francis Hospital, Nsambya, and Uganda
Martyrs’ Hospital Lubaga.

2. To determine the side effects of high dose compared to standard dose caffeine in preterm infants.
Kampala, Nsambya
Kampala, Lubaga
Uganda 2025-10-21 9:08:50 2028-10-21 122 participants preterm babies born at the study sites during the study period with a New Ballard score ≤ 34 weeks no sponsorship Medical and Health Sciences Clinical Trial Degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women
REFNo: HS6666ES

To evaluate the efficacy of MK-8527 qm
compared to FTC/TDF qd for the
prevention of HIV-1 infection as assessed
by the incidence rate per year of adjudicated
HIV-1 infections.
Hypothesis: MK-8527 qm is superior to
FTC/TDF qd with respect to the hazard
ratio for HIV-1 infecti
Mityana,
Kalangala,
Kampala,
Masaka,
Wakiso,
Uganda 2025-10-16 17:51:09 2028-10-16 Approximately 4580 participants 16 to 30 years of age Merck Sharp & Dohme LLC Medical and Health Sciences Clinical Trial Non-degree Award
Helen Byakwaga
ID: UNCST-2019-R001168
A Phase III/IV factorial randomised double-blind trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin/ezetimibe versus pitavastatin, in patients with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk (Optimising metabolic management on integrase-based antiretroviral therapy – the OPTIMAR Study)
REFNo: HS5819ES

To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on: fasting lipids, cardiovascular disease risk assessment measures; inflammatory biomarkers; and safety and tolerability,To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on: intermediate markers of cardiovascular disease risk; cardiovascular disease risk assessment measures; clinical consequences of increased body weight; and safety and tolerability of dapagliflozin,To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on LDL concentration change from baseline to week 24,To assess the impact of dapagliflozin vs. placebo on absolute weight change from baseline to week 24,The overall objective of the study is to examine the impact of dapagliflozin vs. placebo on metabolic parameters in PWH with high metabolic risk who are on INSTI-based ART.,
Kampala, Mulago I
Uganda 2025-09-30 14:11:23 2028-09-30 30 at the Infectious Diseases Institute Kampala All adults aged 40-75 years, both female, all tribes will be included. The Kirby Institute Medical and Health Sciences Clinical Trial Non-degree Award
Joweria Nambooze
ID: UNCST-2019-R001118
Effect of consumption of cape gooseberries on blood glucose control among patients with type 2 diabetes mellitus in Kampala, Uganda
REFNo: HS6017ES

To evaluate patient adherence to dietary interventions involving gooseberries,To compare change in glycated hemoglobin (HbA1c) levels among T2DM patients consuming gooseberries regularly as part of their diet with those following a regular diet. ,To assess the effect of regular consumption of gooseberries on fasting blood glucose levels in T2DM patients.,To evaluate the effect of cape gooseberries on blood glucose control among patients with T2DM in Kampala, Uganda.,
Kampala, All parishes
Uganda 2025-09-26 18:13:11 2028-09-26 200 The study will include adult patients with T2DM who attend the Saint (St) Francis Nsambya hospital diabetes clinic and the Mulago hospital diabetes clinic in Kampala. Convenience sampling will be used to select patients from these clinics who meet specific study criteria and are readily accessible. The two study sites will be purposively selected due to having established T2DM clinics, high patient volume, diverse population and proper patient records. However, the study participants will be randomly allocated to the study arms. Kyambogo University Medical and Health Sciences Clinical Trial Non-degree Award
Patrick Okema
ID: UNCST-2025-R019099
Insulin storage in low resource settings, impact on the glycated hemoglobin.
REFNo: HS6078ES

To determine the modalities of insulin storage in children and adolescents with T1D in low resource settings and the effects on their Hemoglobin A1C (HbA1C) in northern Uganda
Gulu, All parish
Amuru, All parish
Nwoya, All parish
Omoro, All parish
Uganda 2025-09-26 18:07:55 2028-09-26 60 - 100 Children and young adolescent with Type1 diabetes registered and is receiving care at the Gulu Regional Referral Hospital under the age of 23 years Sonia Nabeta Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Jef VanPuyenbroeck
ID: UNCST-2025-R017911
Monitoring anthelmintic resistance in goats in Nwoya District, Uganda
REFNo: A617ES

Main objective:
To assess the efficacy of anthelmintics commonly used by goat farmers in Nwoya district.
Specific Objectives:
1. To determine the prevalence of GIN infesting goats in Nwoya district.
2. To determine nematode species infesting goats in Nwoya district, through coproculture and molecular speciation.
3. To compare the expenses to perform routine FECRT, with McMaster and Mini-FLOTAC, for monitoring anthelmintic resistance in Uganda.
4. To assess the efficiency of survey designs and fecal egg count methods to determine drug efficacy at a certain cost and endemicity.
Nwoya, All
Nwoya, All
Nwoya, All
Belgium 2025-09-26 18:06:25 2028-09-26 383 All goat herds, kept for livelihood purposes, in Nwoya District will be considered to be included in this study. Ghent University Agricultural Sciences Clinical Trial Degree Award
Adoke Yeka
ID: UNCST-2021-R004300
An open-label, randomised, controlled, non-inferiority trial to compare the efficacy, safety and tolerability of a fixed dose Triple Artemisinin-based Combination Therapy (TACT) artemether-lumefantrine-amodiaquine versus first-line Artemisinin-based Combination Therapies (ACTs) for the treatment of uncomplicated Plasmodium falciparum malaria
REFNo: HS6344ES

To compare the efficacy of ALAQ vs AL and ALAQ vs ASAQ as defined by the 28-day PCR corrected adequate clinical and parasitological response (ACPR).
Tororo, Selected parishes
Busia, Selected parishes
Uganda 2025-09-26 17:41:17 2028-09-26 1680 Male or female Participants with acute uncomplicated P. falciparum malaria University of Oxford Medical and Health Sciences Clinical Trial Non-degree Award
Robert Ssekitoleko
ID: UNCST-2019-R001716
A Feasibility and Safety Study of the KeySuite Laparoscopic Devices for Cancer Diagnosis in Uganda
REFNo: SIR493ES

1. To evaluate potential safety issues associated with the use of the KeyScope in patients with intra-abdominal cancers or suspected cancers .
2. To determine the clinical performance of the KeyScope in viewing tissue masses in the abdomen.
3. To determine the clinical performance of the KeyLoop in retraction of the abdominal wall during laparoscopic surgery
4. To determine the acceptability of KeySuite laparoscopic devices in aiding to obtain laparoscopic biopsies

Kampala, Mulago II
Uganda 2025-09-26 17:12:49 2028-09-26 12 The study is targeting 12 adult patients with cancer advised for an intra-abdominal biopsy to be collected for confirmatory. The study will target patients aged between 18 and 60 years. National Institute of Health Engineering and Technology Clinical Trial Non-degree Award
Catriona  Waitt John
ID: UNCST-2019-R001068
Drug Optimisation for LMICs in Pregnant HIV mothers and their INfants: temporary switch to CAB/RPV long acting injections in postpartum period
REFNo: HS5982ES

To characterise drug exposure in breast milk, and drug transfer to infants through breastfeeding, as well as infant drug elimination. To characterise the elimination of CAB/RPV by describing PK profiles of IM CAB/RPV LA after last injection between 48 and 96 weeks. To establish strategies on how to safely re-establish oral ART after discontinuation of IM CAB/RPV LA at 48 weeks and switch back to daily oral ART. To explore early postpartum PK of CAB/RPV in maternal plasma and breastmilk. To demonstrate antiviral activity and impact on retention in HIV care of temporarily switching to CAB/RPV LA compared with continuation of daily oral ART over 48 weeks.,
Kampala, Kampala
UK 2025-09-17 13:21:16 2028-09-17 309 Consenting pregnant women living with HIV University of CapeTown Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Bisegerwa
ID: UNCST-2022-R011022
Accuracy of Pulse Oximeters with Profound Hypoxia
REFNo: HS6506ES

To generate two to three evidence-based recommendations to regulatory and procurement bodies within six months of study completion to guide pulse oximeter selection for diverse populations.,To collect and contribute data on pulse oximeter accuracy across diverse skin tones to an open-access device performance database by the study’s end, enabling manufacturers to refine pulse oximeter technology and ensure equitable performance across all skin tones, especially in low-resource settings.,To replicate the UCSF Hypoxia Lab in Uganda by establishing a fully equipped and operational facility within a year to evaluate pulse oximeter accuracy across diverse skin tones and hypoxia levels.,To evaluate the accuracy of pulse oximeters under controlled hypoxic conditions in a diverse population in Uganda, with a focus on understanding and addressing disparities in device performance related to skin pigmentation.,
Kampala, Kololo
Uganda 2025-09-12 17:03:12 2028-09-12 432 This study will be done on healthy male or female participants between the ages of 18-50 years. Association of Anesthesiologists of Uganda Medical and Health Sciences Clinical Trial Non-degree Award
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