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  
Rhoda Wanyenze
ID: UNCST-2021-R013352
 PILOT OF A NETWORK-DRIVEN, ADVOCACY INTERVENTION TO PROMOTE CERVICAL CANCER SCREENING IN UGANDA (PHASE 3)
REFNo: HS1633ES

The proposed intervention development study seeks to improve cervical cancer screening in Uganda by engaging and training local public health researchers and program implementers, and empowering women living with cervical cancer risk (WLCCR), defined as women who have ever received CC screening procedures, to advocate for CC screening and early treatment among women in their social networks.
 Namayingo, Buyinja
 Uganda 2021-08-16 2024-08-16 40 index participants; 120 social network members This study represents phase 3 of the study that was earlier registered with UNCST. During this phase, we will aim to enroll women living with cervical cancer risk (hereafter referred to as the 'index participants'), defined as women who have ever been scr Glenn Wagner (RAND Corporation, USA) Medical and Health Sciences Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
 IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Version 3.0, dated 13 August 2020
REFNo: HS1356ES

Primary Objectives:
Cohort 1
1.To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents
2.To confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16
Cohort 2:
1.To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents
Secondary Objectives: Cohort 1
• To monitor maintenance of viral suppression through Week 16 in HIV-infected, virologically suppressed adolescents
• To evaluate the tolerability and acceptability of CAB LA through Week 16 in HIV-infected,virologically suppressed adolescents
• To evaluate the tolerability and acceptability of RPV LA through Week 16 in HIV-infected,virologically suppressed adolescents
Secondary Objectives: Cohort 2
• To assess safety of oral CAB + oral RPV followed by CAB LA + RPV LA through Week 48 in HIVinfected, virologically suppressed adolescents
• To evaluate repeat-dose pharmacokinetics of CAB LA + RPV LA through Week 24, and through
Week 48 in HIV-infected, virologically suppressed adolescents.
• To assess antiviral activity of CAB LA + RPV
 Kampala, Mulago
Kampala, Mulago 1
 Uganda 2021-08-11 2024-08-11 155 participants overall but MUJHU plans to enroll 18-25 participants HIV‐1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, National Institutes Of Health Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Performance Evaluation of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in Uganda
REFNo: HS1606ES

Main objective
To evaluate the field performance of the m-PIMATM HIV-1/2 VL plasma VL in identifying virological failure (VF) in adults on ART. The performance will be compared to standard PCR assays used at UNHLs and UVRI.
2.3.2 Primary objectives
I). To evaluate the diagnostic accuracy using the sensitivity, specificity, NPV, PPV, FPR and FNR of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in comparison to a reference assay of HIV-1 RNA PCR in identifying HIV-VF at the WHO recommended threshold of 1000 copies/ml for HIV-1 infected.
II). To determine the operational characteristics of the m-PIMAâ„¢ HIV-1/2 VL plasma assay, such as ease of-use of the assay using the standardized system usability scale (SUS) by laboratory and no laboratory personnel
III). To determine changes in turn-around time and ease of clinic workflow integration.
IV).To determine acceptability of the m-PIMAâ„¢ HIV-1/2 VL plasma assay by the study participants

 Kampala, Kampala
Buikwe, Buikwe
Kayunga, Kayunga
Mpigi, Mpigi Town Council
 Uganda 2021-08-11 2024-08-11 403 participants -Adult ART patients who are ≥18 years old on ART for ≥ 6 months will be approached for study participation. Historical controls will be used to compare the time to initiation of intensive adherence counselling (IAC) between the m-PIMA and the standard - Abott Diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Hannah Kibuuka
ID: UNCST-2020-R014355
 A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older
REFNo: HS1638ES

1. To assess, in participants who are SARS-CoV-2 naïve, the
clinical efficacy of the CoV2 preS dTM-AS03 vaccines for
the prevention of symptomatic COVID-19 occurring ≥ 14
days after the second injection.

2. To assess the safety of the CoV2 preS dTM-AS03 vaccines
compared to placebo throughout the study.
 Kampala,
Wakiso,
Mukono,
Uganda 2021-08-10 2024-08-10 800 Adults 18 years of age and older Sanofi Pasteur Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 An open label, Phase 2 study to evaluate the safety and immunogenicity of an Ad26.ZEBOV booster dose in Human Immunodeficiency Virus Positive (HIV+) adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen
REFNo: HS1350ES

• To assess the safety and tolerability of a Ad26.ZEBOV booster dose in HIV positive adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen.

• To assess humoral responses induced by the booster dose against EBOV glycoprotein (GP), as measured by Filovirus Animal Non-Clinical Group (FANG) Enzyme-Linked Immunosorbent Assay (ELISA) at 7 and 21 days.

 Masaka, NOT APPLICABLE
Lwengo, NOT APPLICABLE
Bukomansimbi, NOT APPLICABLE
Kalungu, NOT APPLICABLE
 Uganda 2021-08-04 2024-08-04 50 participants Participants must be healthy (based on physical examination, medical history, and clinical judgment) HIV positive adults who received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in the VAC52150EBL2002 trial and were aged ≥18 to ≤50 years at the tim London School of Hygiene & Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
 Determination of Adequate TUberculosis Regimen in Adults and adolescents hospitalised with HIV-associated severe immune suppression (Acronym: DATURA).
REFNo: HS1487ES

Primary objective: To estimate the impact of an intensified initial phase of tuberculosis (TB) treatment on mortality at 48 weeks among HIV-infected adults and adolescents hospitalised for TB with CD4 ≤ 100 cells/μL in comparison with the standard TB regimen. Secondary objectives: To estimate the impact of an intensified initial phase of TB treatment, in comparison with the standard TB regimen, on: ¥ Mortality at weeks 8 and 24 ¥ Adverse events, including: - All grade 3-4 events - Selected grade 2 events of interest - Drug-related adverse events - AIDS defining illnesses - Paradoxical TB-associated immune reconstitution inflammatory syndrome (IRIS) ¥ TB treatment success ¥ TB recurrence ¥ Antiretroviral treatment (ART) response in terms of virological success and immunological response ¥ Adherence to TB treatment and ART ¥ Peak plasma concentrations of rifampicin and isoniazid (and its N-acetyl-metabolite) at day 3, day 7 and week. ¥ Plasma concentrations of efavirenz and dolutegravir at week 4 (i.e. 2 weeks after the onset of ART)
Mbarara, Mbarara
 Uganda 2021-07-16 2024-07-16 1330 15-85years, All sexes, all tribes, ethnicities and religions Inserm-ANRS French National Institute for Health and Medical Research (Inserm) ANRS Infectious Emerging Diseases – Autonomous Agency of Inserm (ANRS) 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
Deborah  Ojiambo
ID:
Efficacy of Group Activity Adherence Counselling (GAAC) for Adolescents with Unsuppressed HIV viral load at three large HIV clinics in Uganda: Randomized controlled trial
REFNo: SS805ES

1.To examine the barriers such as behavior problems and mental health problems to adherence experienced by adolescents living with HIV.
2.To evaluate the efficacy of GAAC in addressing barriers to adherence among adolescents living with HIV.

3.To assess whether GAAC is associated with viral load suppression, among adolescents living with HIV compared to Standard Service Provision (SSP)
 Kampala, Mulago 1
Wakiso, Entebbe
 Uganda 2021-07-07 2024-07-07 300 The population for this study is school-going adolescents living with HIV (12-18 years) who received ART for at least 6 or more months at Mulago ISS, TASO Mulago, TASO Entebbe HIV clinics Makerere University Research and Innovation Fund (RIF) funded by Uganda government Social Science and Humanities Clinical Trial Non-degree Award
Susan  Nabadda
ID: UNCST-2020-R014331
 Diabetes Mellitus Tuberculosis and HIV multimorbidities among adult patients attending Kiruddu National Referral Hospital, Uganda Version 2 7/26/2020.
REFNo: HS1386ES

General Objective
The overall objective of this project is to determine the prevalence of DM among patients with either TB, HIV, and TB-HIV co morbidity. This will help to assess the prevalence of silent DM in these categories of patients.
Specific objectives

1. To describe the prevalence of DM among either TB patients or HIV patients or patients with both TB and HIV co morbidity attending the Kiruddu hospital outpatient clinics
2. To determine the factors associated with DM in patients with HIV alone, TB alone and HIV – TB co-infection.

 Kampala, Buziga
 Uganda 2021-06-29 2024-06-29 1000 Adults of 18 years and above, HIV-infected patients or TB patients receiving care at Kiruddu National Referral Hospital (patients with both TB and HIV will also be included) However, patients who will be critically ill and in need of emergency clinical c Beckton Dickinson and the United States Centers for Disease Control and Prevention (CDC), Uganda. Medical and Health Sciences Clinical Trial Non-degree Award
JUSTUS BARAGEINE KAFUNJO
ID: UNCST-2020-R014150
 COMPREHENSIVE REINTEGRATION ASSISTANCE FOR WOMEN WITH FEMALE GENITAL FISTULA: INTERVENTION PILOTING
REFNo: SS890ES

Aim 1: To understand the feasibility and acceptability of a pilot reintegration program for female genital fistula. Aim 2. To assess the acceptability of the pilot reintegration intervention to patients, intervention implementors. Aim 3. To assess the preliminary effectiveness of the pilot reintegration intervention.
 Kampala, MULAGO
,
Uganda 2021-06-24 2024-06-24 40 (30 women to participate in the intervention and indepth interview plus 10 stake holders Women aged 18 years and above or considered emancipated minors under Ugandan law who are undergoing genital fistula surgery. U.S. Eunice Shriver Kennedy National Institute of Child Health and Development. Social Science and Humanities Clinical Trial Non-degree Award
Mohammed Lamorde
ID: UNCST-2019-R001293
 Drug Interactions between Dolutegravir (DTG) and escalating-doses of Rifampicin (RIF) Study
REFNo: HS1376ES

The secondary objectives of the trial are to determine the safety and tolerability of the DTG/RIF combination, the PK of RIF, induction of PgP and CYP3A4 and effect of DTG on appetite,Primary Objective The primary objective of the study is to determine changes to the PK parameters of DTG when administered with standard, medium and high doses of RIF in HIV-negative, TB-monoinfected participants coming to the end of continuation TB therapy with standard doses of RIF and INH over a 10 week period,
 Kampala, Mulago 1
 Nigeria 2021-06-23 2024-06-23 18 Inclusion Criteria • Ability to give informed consent prior to participation • Willing and able to comply with all study requirements • Receiving standard doses of RIF and INH • HIV antibody negative • Male or non-pregnant, non-breastfeedin University of Liverpool Medical and Health Sciences Clinical Trial Non-degree Award
Irene Andia Biraro Rebecca
ID: UNCST-2019-R001475
 A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People with Diabetes.
REFNo: HS1112ES

Primary objective:
To assess the efficacy of preventive therapy with a 12-week course of rifapentine and isoniazid (3HP) against the development of probable or definite TB disease over 24 months in people with Diabetes Mellitus (DM) who are latent TB infection (LTBI) test positive.
Secondary objectives:
• To assess the efficacy of 3HP against the development of possible, probable or definite TB disease over 24-40 months in people with DM who are latent tuberculosis infection test positive
• To compare the proportions who complete treatment between arms
• To compare the occurrence of adverse events between arms
• To compare the rate of TB or death between arms
• To compare the overall mortality rate between arms
• To explore the efficacy of 3HP against development of probable or definite TB in those who are LTBI test positive, across the following sub-groups, separately: study site (n=3); age groups; duration of DM; level of glycaemic control (baseline HbA1C) and body mass index (BMI).
• To assess the efficacy of 3HP against development of probable or definite TB, in two restricted analyses: TST positive and IGRA positive participants.
• To carry out sub-studies including i) an economic modelling and cost effectiveness study, ii) a cohort study of those who are IGRA and TST negative a baseline, iii) a cross-sectional study of HIV and TB prevalence and DM phenotype, (iv) evaluation of point-of care (POC) testing for LTBI, and computer-assisted X-ray, (v) a public health study of patient management, and v) future genetic studies.

Kampala, Munyonyo
Wakiso, Kasangati
Kampala, Rubaga
 Uganda 2021-06-18 2024-06-18 1500 Inclusion criteria I. Enrolled in diabetes care with a history of DM and current use of anti-diabetic medication (‘known DM’); OR in the absence of anti-diabetic medication an HbA1c of ≥6.5% (48 mmol/mol) or a fasting venous plasma glucose of ≥7. National Institute for Medical Research, Mbeya Tanzania Medical and Health Sciences Clinical Trial Non-degree Award
Julius Okuni Boniface
ID: UNCST-2019-R000963
 A MULTI-COUNTRY, SINGLE-BLINDED, PHASE 2 STUDY TO EVALUATE RAPID DETECTION SYSTEMS OF SARS-COV-2
REFNo: HS1425ES

1. To determine the clinical sensitivity of the test assays compared to the real-time RT-PCR-based method.
2. To determine the specificity of the test assays compared to the real-time RT-PCR-based method.

 Kampala, Mulago
 Uganda 2021-06-16 2024-06-16 500 The age group will be adults from 18 years and above. The samples will be collected from archives at the Biorepository in the Department of Immunology and Molecular Biology, Makerere University. The samples will be from people from patients that had compl EDCTP Medical and Health Sciences Clinical Trial Non-degree Award
Musa Sekikubo
ID: UNCST-2021-R014010
 A multi-Centre, randomised, placebo controlled, double-blind, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine (GBS-NN/NN2) in women who are pregnant and living with HIV and women who are pregnant and do not have HIV
REFNo: HS1390ES

Objectives
Primary Objectives:
Safety:
To evaluate the safety and tolerability of the GBS-NN/NN2 vaccine in women living with HIV and women without HIV and their newborn babies from vaccination up to delivery/birth.
Immunological:
To compare the transfer rate of vaccine- specific immunoglobulin G (IgG) antibody concentrations from the mother to the baby at birth in women living with HIV with the transfer rate in women without HIV. This endpoint will be used to determine the sample size calculation.
Secondary Objectives
Safety: The safety and tolerability of the GBS-NN/NN2 vaccine in the mother and baby over the first 6 months post-partum, as assessed at 6 months of age.
Immunological: The secondary immunological objectives are:
• To compare IgG antibody responses, specific to the GBS-NN/NN2 vaccine, induced by the first and second vaccine doses over time in pregnant women living with HIV and pregnant women without HIV.
• To evaluate the concentration of IgG antibodies specific for the GBS-NN/NN2 vaccine up to 6 months post-delivery in the mother and baby in women with and without HIV.
• To determine the concentrations of vaccine specific IgG to GBS-NN/NN2 in cord blood at delivery in babies born to women with and without HIV.
Exploratory Objectives
• To compare between groups the isotype composition of the vaccine specific antibodies; in particular IgG and IgA as well as their subclasses, i.e. IgG1-4, IgA1 and IgA2 in maternal and cord blood.
• To compare between groups the vaccine specific IgG antibodies to Rib, Alp1, Alp2 and AlpC, GBS-NN and GBS-NN2 in maternal and cord blood.
• To compare between groups the functional activity of vaccine specific antibodies from cord blood in an opsonophagocytic killing assay (OPkA) and other in vitro assays in selected samples.

 Kampala, Kawempe
 Uganda 2021-06-08 2024-06-08 50 HIV negative and HIV positive pregnant women aged 18 to 40 years attending Kawempe national referral Hospital MINERVAX AS Medical and Health Sciences Clinical Trial Non-degree Award
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