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  
Jolly  Kamugisha G.K.
ID: UNCST-2023-R005715
Performance and Factors Affecting the Implementation of the Integrated Management of Acute Malnutrition Programme: A Study of Kampala, Mukono, Wakiso and Kayunga Districts
REFNo: HS6084ES

5. To document the lessons learnt and best practices during implementation of the IMAM program in the four target districts during the calendar year 2022 and 2023.,4. To establish factors that affect the utilization of IMAM services in the four target districts.,3. To determine factors influencing treatment outcomes of children with wasting in the four target districts.,2. To determine the performances of the integrated management of acute malnutrition program in the four target districts during the calendar year 2022 and 2023.,1. To identify the communities contributing to a high burden of childhood wasting caseload in health facilities in four target districts (Kampala, Mukono, Wakiso and Kayunga),The overall objective of this study is to assess the nutrition service delivery and factors influencing utilization of the IMAM programme in Kampala, Mukono, Wakiso and Kayunga districts,
Kampala,
Mukono,
Wakiso,
Kayunga,
Uganda 2025-06-20 8:41:29 2028-06-20 Sample size varies by objective as follows: Objective 1: 1440 records; Objectives 3-5: 5 key informants ()KIIs) at policy level; 8 KIIs - district and facility administrators; 7 KIIs for health workers at facility level. 1) Children aged < 5years with acute malnutrition - both boys and girls (Records review) 2) Caregivers of children treated acute malnutrition (both females and males aged 18+years) 3) Village Health Teams (both males and females adults aged 18+ years) 4) Health workers caring for children with acute malnutrition (Male and females aged 18+ years; District and health facility administrators (male and female aged 18years 5) Policy level stakeholders, both male and female aged 18+ years) UNICEF Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
REFNo: SS3990ES

Suubi4PrEP will examine the effect of a multilevel intervention, combining HIV risk reduction that incorporates sessions on PrEP, peer supporters with lived experiences to facilitate linkage to and continued care, and economic empowerment components targeting financial barriers associated with PrEP access, PrEP initiation, uptake and adherence among AGYW in Uganda. Study aims are:

Aim 1: Examine the impact of Suubi4PrEP on PrEP initiation (primary outcome); and PrEP adherence (secondary outcome).

Aim 2: Examine the effect of Suubi4PrEP on hypothesized mechanisms of change (financial stability, PrEP stigma, self-efficacy, depressive symptoms, and social support) and intervention mediation.

Aim 3: Use mixed methods to explore multi-level factors that influence PrEP initiation and adherence.

Aim 4: Assess the cost and cost-effectiveness of the interventions.

Masaka, Nyendo
Lwengo, Kinoni
Kyotera, Kakuuto
Kalungu, Bukulula
Rakai, Kakuuto
Sembabule, Sembabule TC
Bukomansimbi, Mbiriizi
Uganda 2025-06-20 7:41:25 2028-06-20 600 The target study population for the proposed Suubi4PrEP study is AGYW (15-24 years) living in HIV hotspots in the greater Masaka region of Uganda. Emancipated minors (below 18 years) will not need parental/caregiver consent. In Uganda, the National Guidelines for Research Involving Humans as Research Participants (NGHRP) define a child as any person below the age of 18. On the other hand, an emancipated minor is defined as an individual below the age of 18 who are pregnant, married, have a child, or are self-sufficient. Inclusion Criteria. Female between 15-24 years. AGYW will be screened for HIV risk as determined by the national risk screening tool developed by the Uganda National AIDS Control Program, in alignment with national PrEP guidelines. AGYW will be deemed to be at substantial risk, and eligible to participate in the study, if they report at least one of the seven high-risk sexual behaviors on the risk assessment tool. Exclusion criteria. A participant will be excluded if they are: 1) HIV Positive, 2) unable to understand the study procedures and/or participant rights during the informed consent process, or 3) they are unwilling or unable to commit to completing the study. If the potential participant has emergency needs (e.g., hospitalization), they will be referred for care instead. Peer Supporters. These will be women who are HIV negative, enrolled and adhering to PrEP. We expect to recruit at least four peer supporters at each of the 20 sites receiving the PS intervention component. National Institute for Mental Health Social Science and Humanities Clinical Trial Non-degree Award
Denis Nansera
ID: UNCST-2024-R004002
Improving HIV testing among Children under five in Rural Uganda
REFNo: HS5829ES

The main objective of this study is to develop a traditional healer facilitated paediatric HIV testing program to improve access to paediatric HIV testing. To do this, we will first use qualitative study methods to determine factors that influence HIV testing among paediatric clients of TH and guide adaptation of the TH-facilitated HIV testing program for children. We will then implement a pilot study to evaluate offering paediatric HIV testing at traditional healer locations in southwestern Uganda.
Uganda 2025-05-29 17:12:49 2028-05-29 465 Aim 1: Key stakeholders for Aim 1 will be defined as 1) adult caretakers of children ≤5 years old who receive care from TH in Mbarara District; 2) TH who care for more than 15 children under five each month; and 3) paediatric HIV clinicians from surrounding Health Centres III and IV. All participants will be 18 years or older, and able to provide informed consent. HIV clinicians must also have been in a patient-facing position (doctor, nurse, social worker, counsellor) for at least one year at the time of enrolment. Aim 2: The study population will be ten TH with monthly volume of 15 children five years old or younger, and 200 children 18 months to 5 years of age who receive care from these TH practices in Mbarara District. Inclusion criteria for TH: aged 18 or older, consent to recruitment of children at their practice, agree with goals of the study and associated procedures, and agree to attend all study-related training. Exclusion criteria will be the same as in Aim 1 above. Inclusion criteria for children are: 18 months to 5 years old; have a parent or caregiver who can provide informed consent; not previously tested for HIV in the past three months; and not previously known to be HIV-infected. National Institute of Mental Health Medical and Health Sciences Clinical Trial Non-degree Award
Nanyonga Elizabeth Monica
ID: UNCST-2025-R018232
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REFNo: SIR516ES

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Uganda 2025-05-27 9:30:38 2028-05-27 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA Engineering and Technology Clinical Trial Non-degree Award
Fred  Bulamba
ID: UNCST-2020-R014888
Rule of THUMB: A multi-centre cluster trial evaluating the implementation of a perioperative care complex intervention to improve outcomes from haemorrhage during and after caesarean section in African hospitals
REFNo: HS5855ES

To evaluate the effect of the trial intervention on patient outcomes relevant to future trials.,To evaluate whether implementation of the ‘Rule of THUMB’ perioperative complex intervention increases risk assessment and improves diagnosis and compliance with proven interventions for haemorrhage during and after caesarean section.,
Mbale, Hospital Cell
Uganda 2025-05-14 9:24:07 2028-05-14 600 Any patient who requires a caesarean section Department of Anaesthesia and Perioperative Medicine Medical and Health Sciences Clinical Trial Non-degree Award
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