Approved Research This page provides a searchable list of all research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology(UNCST).
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Name Title Nationality Approval Date Expiry Date Field of Science/Classification Trial Type Research Type  
Victoria Ndyanabangi
ID: UNCST-2021-R012645
IMPAACT 2036: Phase I/II Study of the Safety, Tolerability,Acceptability, and Pharmacokinetics of Oral and Long-ActingInjectable Cabotegravir and Rilpivirine in Virologically SuppressedChildren Living with HIV-1, Two to Less Than 12 Years of Age, DAIDSStudy ID #38932 IND # 138754
REFNo: HS2688ES

To propose the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV)followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA)in children living with HIV-1, and to describe participant choice and experience with theregimen with or without an oral lead-in period.
To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable)through Week 24
To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oraland injectable) through Week 24
To assess the safety of CAB + RPV (oral and injectable) through Weeks 48 and 72
To describe the repeat-dose pharmacokinetics of injectable CAB LA + RPV LA throughWeeks 48 and 72
To assess the maintenance of viral suppression of CAB + RPV (oral and injectable)through Weeks 24, 48, and 72
To evaluate the tolerability and acceptability of injectable CAB LA + RPV LA throughWeeks 24, 48, and 72
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during study treatment
To assess immunologic activity of CAB + RPV (oral and injectable) through Weeks 24,48, and 72
To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable)and 44 weeks of CAB LA + RPV LA (injectable only)
To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV(oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe the maintenance of viral suppression and immunologic activity of 48 weeks ofCAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CABLA + RPV LA (injectable only)
To characterize long-term safety and washout PK through 48 weeks after permanentdiscontinuation of injectable CAB LA + RPV LAV LA
To characterize PK of CAB + RPV oral formulations when dispersed in liquid vs. directly ingested (Weight Bands 3, 4 and 5)
Uganda 2023-03-16 12:55:20 2026-03-16 Medical and Health Sciences Clinical Trial Non-degree Award
Charles Batte
ID: UNCST-2021-R013587
The impact of COVID-19 on school enrolment and mental health of children in the Manafwa Watershed area in Uganda.
REFNo: HS2725ES

To assess the coping strategies of school-going children in the Manafwa Watershed area during the COVID-19 pandemic.,To assess the post-lockdown mental health status of school-going children in the Manafwa Watershed area. ,To evaluate the effects of COVID-19 lockdown on school enrolment of children in the Manafwa Watershed area.,To assess the impact of COVID-19 and its associated restrictive measures on school enrolment and mental health of children in a disaster-prone area, Manafwa Watershed area, in Eastern Uganda.,
Uganda 2023-03-16 12:51:27 2026-03-16 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Jack Richardson Lloyd
ID:
The role of social play in the development of wild mountain gorillas in Bwindi Impenetrable National Park, Uganda
REFNo: NS490ES

(1) determine how biological, ecological, and social factors influence amount of time spent in social play.
(2) examine how structural components of play (asymmetry, dominance, play
partnerships, play type) can differentiate between functions.
(3) investigate proposed trade-offs and developmental outcomes of social play.
UK 2023-03-16 12:48:10 2026-03-16 Natural Sciences Non-Clinical Trial Degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
GS-US-380-1474: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
REFNo: HS2708ES

This is a multisite, multi-cohort study that aims to recruit subjects in four weight-based cohorts (i.e. Cohort 1, 2, 3 and 4), with each cohort having specific objectives aligned with it. Baylor Uganda site will recruit subjects in cohort 4 with is further subdivided in 4 weight-based sub-groups. The study objectives in relation to the Cohort 4 are as follows;
Cohort 4
Group 1:
The primary objective of this study is:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets

• To evaluate the antiviral activity of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Weeks 24 and 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
Group 2:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the antiviral activity of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg.
Group 3:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the antiviral activity of B/F/TAF 3.75/15/1.88 mg (administration of 1 × B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
Group 4:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg.

• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

• To evaluate the antiviral activity of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

Uganda 2023-03-16 12:47:17 2026-03-16 Medical and Health Sciences Clinical Trial Non-degree Award
Bjorn Van Campenhout -
ID: UNCST-2020-R014080
Increasing Adoption and Varietal Turnover of Seed: Consumer and Producer Side Interventions
REFNo: SS1657ES

The study will be implemented through a cluster randomize control trial, where a sample of treatment villages (clusters) will receive producer side treatments (free seed trial packs or discounted seed trial packs of a poorly adopted improved maize variety, Bazooka) while other treatment villages will receive a consumer side intervention involving cooking and tasting demonstration of maize from the improved variety. However, in both treatment and control groups, we will inform farmers about the existence of the improved seed variety and the benefits of using them, to be able to isolate the effect of the trail pack from merely knowledge effects.
Belgium 2023-03-16 12:43:52 2026-03-16 Social Science and Humanities Non-Clinical Trial Non-degree Award
Jennifer  Kealy
ID:
Community Engagement in Paediatric Biobanking Governance in Uganda.
REFNo: SS1651ES

The aim of this study is to provide IARC and the Ugandan Government with actionable recommendations concerning the development of paediatric biobanking guidelines. The primary objective is to identify the key ethical issues/concerns for researchers, laboratory staff, and health authorities in Uganda, specifically related to public trust in biobanking, and how trust/ trustworthiness could be addressed in paediatric biobanking governance as well as how the community might be engaged.
• Does it hold true that trust/ trustworthiness is contextual and that effectively would preclude any harmonisation of guidelines for biobanking? Or is there any common ground on which to build global /international guidelines,
• What are the gaps in biobanking in Uganda, particularly with respect to paediatric biobanking and,
• How can Uganda create paediatric biobanking guidelines that reflect the needs identified by communities and what would this look like, and,
• How can biobanks show they are trustworthy through their governance and what does that look like to Uganda? Is it sufficient to be transparent and accountable or are other cultural/economic/religious/aspects that parents consider in their assessment of trust in a biobank?
• How can ethical considerations related to biobank governance be addressed in an inclusive, collaborative and deliberative manner

USA 2023-03-16 12:41:09 2026-03-16 Social Science and Humanities Non-Clinical Trial Degree Award
Jennifer Verdolin
ID:
Establishing a Long-Term Behavioral and Ecological Monitoring Research Program in Bwindi Impenetrable Forest National Park and Mgahinga Gorilla National Park
REFNo: NS500ES

1) Understand the factors contributing to within and between group variability in parasite infection and transmission; 2) Characterize the diet of mountain gorillas across different habitats in Bwindi Impenetrable Forest National Park and Mgahinga Gorilla National Park; 3) Explore habitat use and spatial dynamics of mountain gorillas in Bwindi Impenetrable Forest National Park and Mgahinga Gorilla National Park; 4) Collaborate with UWA to yield insights critical for the protection and management of mountain gorillas and other species in Bwindi Impenetrable Forest National Park and Mgahinga Gorilla National Park; 5) Characterize the biodiversity of Bwindi Impenetrable Forest National Park and Mgahinga Gorilla National Park, including genomics of multiple species using opportunistically collected fecal samples. These species include but would not be limited to forest elephants and pangolins.
USA 2023-03-16 12:39:44 2026-03-16 Natural Sciences Non-Clinical Trial Non-degree Award
Florence Kyoheirwe Muhanguzi
ID: UNCST-2021-R002777
Building women smallholder farmers’ empowerment and adaptive capacities: A pathway to enhancing women’s resilience to climate change in Uganda
REFNo: SS1660ES

General objective
● To strengthen the empowerment and adaptive capacity of women smallholder farmers in the cattle corridor of Uganda using gender transformative approaches.

Specific objectives
1. Establish women smallholder farmers’ levels of empowerment and adaptive capacities to the effects of climate change;
2. Assess the social cultural gender norms, economic and political trade-offs and barriers to empowerment and climate adaptation by women smallholder farmers;
3. Design and test a mix of gender transformative climate change adaptation innovations that are effective in enhancing women smallholder farmers’ empowerment and resilience to the effects of climate change.
4. Advocate for policies and practices that enhance women smallholder empowerment and adaptive capacities to climate change shocks.

Uganda 2023-03-16 12:37:54 2026-03-16 Social Science and Humanities Non-Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 plus Pyronaridine Administered once Daily for 1 or 2 Days to Adults and Adolescents with Acute Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2736ES

To evaluate the safety and
tolerability of the M5717-
pyronaridine combination in
adult participants with acute
uncomplicated malaria due to
P. falciparum.
Secondary.
o describe the clinical efficacy
of the M5717-pyronaridine
combination in adult participants
with acute uncomplicated
malaria due to P. falciparum
Uganda 2023-03-16 12:35:56 2026-03-16 Medical and Health Sciences Clinical Trial Non-degree Award
Charles Masembe Kikubo
ID: UNCST-2019-R001092
The Dispersal of Antibiotic Resistance and Antibiotics in Water Ecosystems and Influence on livestock and Aquatic wildlife (PAIRWISE)
REFNo: A240ES

i) To investigate the dispersal of Antibiotic Resistant Bacteria (ARB), Antibiotic Resistant Genes (ARG) and Antibiotics (ATB) in surface waters downstream of WWTPs ii) To investigate the carriage of ARB and ARG in livestock linked to surface waters influenced by WWTPs iii) To ascertain the role of aquatic birds in dispersal of ARB and ARG
Uganda 2023-03-09 23:54:51 2026-03-09 Agricultural Sciences Non-Clinical Trial Non-degree Award
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