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  
Isaac Ssewanyana
ID: UNCST-2020-R014336
COMPARISON OF PERFORMANCE OF CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA TEST DEVICE/ TEST REF: ISY-U402 AND CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA RAPID TEST STRIP) REF: ISY-U401 USING SD BIOLINE VERSION 3.0 AS A REFERENCE
REFNo: HS1643ES

The objective of this evaluation is to demonstrate the equivalence of capillary (fingerprick) whole blood and venous whole blood on the Syphilis Ultra test device/ Test strip (Whole Blood/Serum/ Plasma) and strip.
2.4 Exploratory Objectives
• To determine the diagnostic accuracy of the Syphilis Ultra test device/ Test (Whole Blood/Serum/ Plasma) and strip.

Kampala, Naguru
Uganda 2021-09-23 2024-09-23 100 3.1 Subject Population Patients attending the Sexually Transmitted Diseases clinic (STD) at China Friendship Regional referral Hospital Uganda will be enrolled for the study. Patients attending this clinic are referrals from other units presenting with s Ministry of Health Medical and Health Sciences Clinical Trial Non-degree Award
Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
Transitioning children to Optimal Regimens of Paediatric Dolutegravir (TORPEDO) in Uganda
REFNo: HS1596ES

the primary objective for the study is to assess patients’/ caregivers’ preference for a paediatric DTG regimen over their previous regimen, when transitioned from another regimen.

Hoima, Kahora Division
Wakiso, Wkiso
Lira, Lira city
Buikwe, Buikwe
Mayuge, Mayuge
Kampala, Kampala
Uganda 2021-09-22 2024-09-22 approximately 4,000 children and adolescents 0-19 years Clinton Health Access Initiative Medical and Health Sciences Clinical Trial Non-degree Award
ELIZABETH NALINTYA
ID: UNCST-2021-R012882
Long title: A community-based Phase III, cluster randomized trial of point-of-care CD4 testing and enhanced screening and prophylaxis in advanced HIV disease Short title: An enhanced package of care to reduce mortality in advanced HIV disease
REFNo: HS1605ES

Primary Objectives:
1. To assess 24-week survival with retention in care in persons with advanced HIV disease (CD4<200 cells/µL) with point-of-care CD4 testing compared to standard flow cytometry
2. To assess 24-week survival with retention in care with an enhanced diagnostic OI screening and prophylaxis strategy compared to standard WHO package of care in persons with advanced HIV disease
Secondary Objectives:
1. To determine incidence of OIs
2. To measure adverse events with enhanced prophylaxis regimens
3. To assess tolerability and adherence of enhanced prophylaxis regimens
4. To determine incidence and cause of hospitalization for persons with advanced HIV disease
5. To determine cause of death for persons with advanced HIV disease
6. To determine HIV outcomes of viral suppression in persons with advanced HIV disease.
7. Measure cost, cost-effectiveness, and budgetary impact of the CD4 testing strategies, and OI screening and prophylaxis strategies.

Kampala,
Wakiso,
Uganda 2021-09-21 2024-09-21 2400 • Age >18 years • CD4<200 cells/µL • Ability and willingness to give informed consent for the enhanced package of care arm. INFECTIOUS DISEASES INSTITUTE Medical and Health Sciences Clinical Trial Non-degree Award
Achilles Katamba
ID: UNCST-2019-R000540
Human-Centred Design and Communities of Practice to Improve Delivery of Home based Tuberculosis Contact Investigation in Uganda
REFNo: HS1720ES

General Objective: The study aims to assess the effectiveness of an enhanced intervention strategy for implementing TB contact investigation relative to usual care. Specific Objectives: 1.To compare the implementation, effectiveness, and public health impact of TB contact investigation delivered via an enhanced intervention strategy vs. the usual care strategy in a stepped-wedge, cluster-randomized implementation trial. 2.To identify implementation processes and contextual factors that influence the effectiveness of the intervention strategy for TB contact investigation. 3.To compare the costs and epidemiological impact of the intervention and usual care strategies for TB contact investigation.
Masaka, Ndejje
Masaka, Masaka
Butambala, Goombe
Wakiso, Wakiso
Wakiso, Ndejje
Kiboga, Kiboga
Mubende, Kasambya
Mubende, Mubende
Mityana, Mityana
Iganga, Iganga
Bugiri, Bugiri
Jinja, Jinja
Wakiso, Entebbe
Wakiso, Kasangati
Kayunga, Kayunga
Kayunga, Nagalama
Uganda 2021-09-17 2024-09-17 1764 household and close contacts within approximately 2304 eligible index patient clusters over a 16-month period. Household and close contacts of index patients with active pulmonary TB National Institute of Allergy and Infectious Diseases (NIAID) Medical and Health Sciences Clinical Trial Non-degree Award
Martha Musyoka Mbenia
ID:
PREDICTORS OF ADVERSE FETO-MATERNAL OUTCOMES AMONG MOTHERS ADMITTED WITH ANTEPARTUM HEMORRHAGE AT MBARARA REGIONAL REFERRAL HOSPITAL
REFNo: HS1450ES

To describe adverse outcomes and determine predictors of adverse feto-maternal outcomes in mothers with antepartum hemorrhage at Mbarara Regional Referral Hospital
Mbarara, Mbarara
Kenya 2021-09-09 2024-09-09 107 All women of childbearing age presenting with antepartum hemorrhage at Mbarara Regional Referral Hospital Self. No conflict of interest anticipated Medical and Health Sciences Clinical Trial Degree Award
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