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  
Jenny Löfgren
ID: UNCST-2024-R005428
Outcomes of paediatric inguinal hernia repair performed by surgeons versus medical officers
REFNo: HS4508ES

Calculate and compare costs and cost-effectiveness between the two groups. ,Compare patient related outcomes between the group that has been operated on by medical officers versus those who were operated by general surgeons. ,The general objective of the proposed study is to investigate the possibility of task sharing between general surgeons and medical officers in inguinal hernia repair in children in Uganda. ,
Soroti,
Mubende,
Iganga,
Sweden 2024-07-23 15:30:50 2027-07-23 341 Children, both girls and boys, 1-12 years old. Swedish Research Council Medical and Health Sciences Clinical Trial Degree Award
Nura Izath
ID: UNCST-2022-R009201
Autothermo-a wearable continuous temperature measuring bracelet with a central display screen.
REFNo: HS3034ES

To assess the performance of Autothermo- a wearable continuous temperature measuring bracelet and a central display screen in comparison to the standard thermometer.,To assess the feasibility and acceptability of Autothermo among health workers and parents/caregivers of admitted neonates at Mbarara Regional Referral Hospital(MRRH).,
Mbarara, Kamukuzi
Uganda 2024-07-22 16:57:35 2027-07-22 The sample size of the health workers: Convenient sample of 4 out of 6 health workers engaged in the management and care of newborns admitted at Neonatal Intensive Care Unit-MRRH will be enrolled in the study. These study participants who will be nurses on duty will observe the use of Autothermo, ask a few questions and document findings at the end of each shift. The remaining two nurses will be recruited as study research nurses who will enroll and use Autothermo to monitor temperatures of the admitted newborns during the study period. The sample size for parents or caregivers will be calculated basing on the Kish and Leslie where P (0.5) will be the probability of parents or caregivers who will express willingness to have their newborns’ temperatures monitored with Autothermo and q (1-p) will be the probability of those who will not express willingness to use Autothermo. The study will use a precision of 0.126 and a Z of 1.96 giving a total of 60 parents or caregivers to be recruited into the study. Taking Feasibility and Acceptability of Autothermo: The study will include health workers and parents or primary caregivers of newborn. Parents and caregivers who are 18 years and above will be recruited and all health workers in the Neonatal Intensive Care Unit. The parents or caregivers will be informed that the Autothermo bracelet will be removed at any time at their request. Autothermo Performance Assessment: All neonates (0 to 28 days) admitted to the neonatal unit of MRRH during the study period will be screened for inclusion into the study. Ministry of ICT and National Guidance Medical and Health Sciences Clinical Trial Non-degree Award
Grace Kisitu Paul
ID: UNCST-2024-R004102
UNIVERSAL1: Pharmacokinetic study of an optimized dose ratio of dolutegravir/emtricitabine/tenofovir alafenamide fumarate: expediting a UNIVERSAL first line regimen for all children living with HIV in Africa
REFNo: HS4280ES

Primary objective:
To evaluate the pharmacokinetics and short-term safety of DTG and FTC/TAF administered to children living with HIV using a novel dose ratio

Secondary objective:
To evaluate the short-term efficacy of DTG and FTC/TAF
formulations in children using a novel dose ratio

Uganda 2024-07-19 3:45:20 2027-07-19 50 Children aged between 28 days and ≤10 years old weighing ≥3 to <25kg diagnosed with HIV. Fondazione Penta ETS Medical and Health Sciences Clinical Trial Non-degree Award
Janet Nakigudde
ID: UNCST-2019-R000444
PROMOTING MENTAL HEALTH OF TEACHERS AND CAREGIVERS USING A PERSONALIZED MHEALTH TOOLKIT IN UGANDA
REFNo: HS4431ES

3. To examine feasibility of mWEL-T and mWEL-P with parents and teachers from urban and rural regions (including examining feasibility of the implementation procedures and intervention efficacy) (n=160, 80 parents and 80 teachers from urban and rural regions).,To conduct a user-centered testing study to optimize usability of the Teacher and Parent versions of mWEL- mWEL-T and mWEL-P,1. To build a school system capacity (by establishing a cross-discipline digital health leadership & learning collaborative (n=10) and training a group of peer-community health workers (P-CHW) (n=30; 15 peer teachers and 15 peer parents) to implement the mWEL that is developed,The aim of the study is to test mWEL a newly developed mobile app and user-engagement strategies for mental health management and promotion targeting teachers and parents,
Kampala, kibuli
Nakaseke, Nakaseke
Uganda 2024-07-17 14:03:01 2027-07-17 For the proposal sample size N=160 for the full sample The study will enroll parent, teachers and caregivers of children. We shall consider parents who are at least 18 years old, and have a child aged 6-14 years in the enrolled school This study is sponsor by the United States National Institute of Mental Health through a collaboration with New York University, Department of Population Health, New York School of Medicine and Makerere University College of Health Sciences, Department of Psychiatry Medical and Health Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)
REFNo: HS4366ES

Overall Objective
To assess effectiveness and implementation of long-acting cabotegravir (CAB-LA) and oral Truvada (both daily and event driven) through comparison of uptake, retention in care, coital coverage, and participant choice.
Masaka, Masaka
Uganda 2024-07-02 15:08:06 2027-07-02 400 mobile men. HIV negative men aged 18+ years in South Africa and Uganda. Men who are mobile for work, and in the past 6-months have travelled for work or to find work and spent at least one night away from home for work-related purposes. Men male at birth, able and willing to provide informed consent and willing to have an HIV test. MRC/UVRI &LSHTM Uganda Research Unit Medical and Health Sciences Clinical Trial Non-degree Award
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