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).
Search By Approval Date:
Clear Filter Total: 323
Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
Isaac Ssewanyana
ID: UNCST-2020-R014336
 PERFORMANCE EVALUATION OF COVID-19 ANTIGEN RAPID DIAGNOSTIC TESTS
REFNo: HS1690ES

To determine the association of positive index test results with disease stage (days since symptom onset, e.g. acute, early, late), symptom severity and symptom severity.,To determine the diagnostic accuracy of SARS-CoV-2 Ag RDTs on a respiratory specimen (NP swab, OP swab, nasal swab, saliva), vs Cobas SARS-CoV-2 assay as performed in patients presenting with influenza-like illness.,
 pakwach,
Kampala, Mulag0
Kampala, Kiruddu
Masaka, Masaka
Mbarara, Mbarara
 Uganda 2021-09-08 2024-09-08 5000 • Suspected COVID-19 cases ≥ 18 years of age presenting with symptoms at selected reginal and national referral hospitals in Uganda, will be enrolled for the study. These sites were chosen because they are the regional referral hospitals and register FIND, the global alliance for diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A clinical trial to assess the safety and immunogenicity of LNP-nCOV saRNA-02, a self-amplifying ribonucleic acid (saRNA) vaccine encoding the S glycoprotein of SARS-CoV-2, the causative agent of COVID-19, in SARS-CoV-2 seronegative and seropositive Uganda population
REFNo: HS1641ES

Primary Objective:

• To compare the safety and immune responses for SARS-CoV-2 seronegative and seropositive individuals from two immunisations with LNP-nCOV saRNA-02 administered IM 4 weeks apart at one dose level in 42 participants age 18-45 years.

Exploratory Objectives:
• To characterise the humoral and cellular immune responses to LNP-nCOV saRNA-02 administered at one dose given at 0 weeks and 4 weeks for individuals seronegative and seropositive for SARS-CoV-2 antibodies
• To characterise the profile of class and sub-class of antibody responses
• To characterize infection induced immune responses in participants with naturally acquired infection who are also exposed to the vaccine

 Masaka, Butego
 Uganda 2021-09-08 2024-09-08 42 The study will be conducted in healthy young adults as these individuals generate the most robust responses (18-45 years). Both male and female participants will be included and the trial site will attempt to keep an equal proportion, although the priorit The study is sponsored by Imperial College London, funded by the United Kingdom Engineering and Physical Sciences Research Council. Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A behavioural Science Research to Determine Factors that Facilitate Future Uptake of HIV Prevention Products and Multi-Purpose Prevention Technologies to Prevent HIV and Unwanted Pregnancy in Sub-Saharan Africa Universally Accessible HIV Prevention Technologies for African Girls and Young Women through Knowledge Applied from Behavioural Economics (UPTAKE)
REFNo: HS1540ES

Multi-purpose Prevention Technologies (MPTs) to prevent HIV and unwanted pregnancy in Sub-Saharan Africa

i. To understand facilitators of and barriers to uptake and retention of injectable and implantable long acting pre-exposure prophylaxis (LA-PrEP) and MPT to inform product development, using formative behavioural research methods
ii. To design interventions to impact the uptake of new biomedical HIV prevention products, as part of a suite of self-care and self-screening products for sexual and reproductive health, using quantitative behavioural research methods
iii. To test the effectiveness of the alternate design/interventions and strategies, using marketed LA contraceptive products as proxies for LA HIV prevention products in development
iv. To estimate the cost of retention interventions and the cost effectiveness of products and delivery methods among adolescent girls and young women (AGYW) and female sex workers (FSWs) for prevention of pregnancy and/or HIV, using modelling

 Kampala, NOT APPLICABLE
 Uganda 2021-08-31 2024-08-31 1190 Adolescent Girls and Young Women (AGYW) aged 15 to 24 years and Female Sex Workers (FSW) aged 15 to 45 years, Health Care Providers (HCP), and Policy Makers (PM) in Kampala, Uganda and Nairobi, Kenya. Study Size and duration: Stage 1: 30 AGYW, 30 FSW, 10 International AIDS Vaccine Initiative, The Address, 11th Floor, Muthangari Drive, Nairobi, Kenya; T:+254.719.043.000 Medical and Health Sciences Clinical Trial Non-degree Award
BRENDA GATI MIREMBE
ID: UNCST-2021-R013390
 A Phase 3, Randomized, Active Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Women at High Risk for HIV 1 Infection.
REFNo: HS1631ES

Primary Objectives:
1. To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the
prevention of HIV-1 infection as assessed by the incidence rate per year of confirmed
HIV-1 infection.

2. To evaluate the safety and tolerability of oral ISL QM compared to oral FTC/TDF QD as assessed by review of the accumulated safety data

Secondary Objective
1. To evaluate the efficacy of oral ISL QM in reducing the incidence per year of HIV-1
infection relative to the background rate.

 Kampala,
Wakiso,
Mukono,
Mpigi,
Nakaseke,
Luweero,
Buikwe,
Jinja,
Gomba,
Butambala,
Kayunga,
Uganda 2021-08-27 2024-08-27 Approximately 4,500 participants will be randomized (stratified by site and age) in a 1:1 ratio to receive either ISL or FTC/TDF for the duration of the study. Approximately 50% of the global study po Cisgender female participants aged 16 to 45 years of age who are at high risk of acquiring HIV-1 infection. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. 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
View Sort By:

Our Partners