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  
Ronald Kiguba
ID: UNCST-2019-R000844
 Two-way risk communication mobile application use versus traditional methods of adverse drug reaction reporting in Uganda: a cluster-randomized controlled trial
REFNo: HS1366ES

This study will: i) assess the feasibility of implementing a mobile app for the reporting of ADRs associated with DTG and IPT at selected ART-sites in Uganda; ii) describe the characteristics (causality, seriousness, completeness, unexpectedness, severity, outcome) of the DTG- and IPT-linked ADR-reports submitted to NPC using the mobile app; and, iii) determine if use of the mobile app versus existing methods of ADR-reporting (paper-form and web-form) increases by 25% the number of reported ADRs linked to DTG and IPT use during 2.5 years of follow-up, iv) determine the cost and cost-effectiveness of using the mobile app versus existing methods of ADR-reporting.
 Wakiso, Seguku
 Uganda 2021-08-20 2024-08-20 382 Antiretroviral Sites across Uganda The mobile app will be introduced nationwide at 382 high-volume accredited antiretroviral therapy (ART)-sites where MoH implemented the scale up of IPT. These pre-selected ART-sites hold 80% of the patients on ART in Uganda. All HCPs at the pre-selected A Makerere University Research & Innovations Fund Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.
REFNo: HS1669ES

-To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent
virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in
adults who are at risk of severe COVID-19 -2. To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19 -3. To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19
Wakiso, Ssabagabo
 Uganda 2021-08-20 2024-08-20 14,000 age ≥ 40 and at least one comorbidity known to be associated with severe COVID-19, 2) age ≥ 18 and pregnant, 3) age ≥ 18 and HIV-infected. South African Medical Research Council (SAMRC) Cape Town, South Africa. Medical and Health Sciences Clinical Trial Non-degree Award
Philippa Musoke
ID: UNCST-2021-R013523
 ViiV 205858: Open-label access to dolutegravir for HIV-1 infected children and adolescents completing IMPAACT Studies P1093 and P2019 Version 4.0 dated 10 Dec 2020
REFNo: HS1453ES

Primary
• To provide access to age appropriate formulations of dolutegravir (DTG), either as single entity DTG or as fixed dose combination (FDC) abacavir/dolutegravir/lamivudine (ABC/DTG/3TC), in an open-label protocol to eligible participant s who have completed the P1093 or P2019 parent studies.

Secondary

To assess any serious adverse events (SAEs) and any clinical or laboratory adverse events that lead to the discontinuation of IP (DTG or ABC/DTG/3TC FDC).
 Kampala, Mulago
 Uganda 2021-08-20 2024-08-20 3 participants previously enrolled in P1093 at the MU-JHU Site Children aged 0-18 years who are formeerly participants in P1093 study at MU-JHU Site, both male and female and of any tribe as long as their caretakers/parents understand the language of consent. ViiV Health care Company Medical and Health Sciences Clinical Trial Non-degree Award
Deo Wabwire Ogema
ID: UNCST-2021-R013932
 COVPN 3008: Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Version 1.0 16 May 2021
REFNo: HS1659ES

The primary objectives are:
•To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
•To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
•To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

Secondary objectives are to evaluate the following:
•Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
•Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)
The exploratory objectives are to evaluate:
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
•VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
•Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
•Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
•Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial

 Kampala, Mulago 1
 Uganda 2021-08-20 2024-08-20 14,000 across all sites, about 500 from Uganda The study population will include 1.Adults aged 40 years or more with at least one co-morbid factor associated with severe COVID 19 2.People living with HIV who are 18 years and above Pregnant women aged 18 years and above South African Medical Research Council (SAMRC) Medical and Health Sciences Clinical Trial Non-degree Award
Annet Nanvubya
ID: UNCST-2025-R015525
 Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern version 1.0 16-05-2021.
REFNo: HS1677ES

Primary Objectives
The primary objectives of this study are to determine the following:
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
• To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

Secondary Objectives

The secondary objectives of this study are to evaluate the following:
• Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
• Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)

Exploratory Objectives
The exploratory objectives of this study are to:
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
• Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
• Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
• Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial


 Wakiso, Division A and B
 Uganda 2021-08-20 2024-08-20 14,000 This study will enroll participants who meet one or more of the following criteria: 1) Age > 40, who have at least one comorbidity known to be associated with severe COVID-19, 2) women age 18 years or older who are pregnant, and 3) HIV-1-infected indiv South African Medical Research Council(SAMRC) Cape Town, South Africa Medical and Health Sciences Clinical Trial Non-degree Award
Eun Seok Kim
ID:
Cross-sectional prevalence study of schistosomiasis and soil-transmitted helminthiasis with nested open-label randomised controlled study of evaluating the impact of fatty meal co-administration and double-dosing on albendazole effectiveness against hookworm infection among school-aged children in Mayuge district: Implications for Mayuge NTDs Elimination (MANE) Project
REFNo: HS1411ES

Objective 1: To determine the effect of albendazole administration with a fatty meal such as avocado, versus albendazole administration without a fatty meal, on hookworm cure rate and egg reduction rate.

Objective 2: To determine the effectiveness of dual-dose (400mg/day, two consecutive days) versus single-dose (400mg) albendazole treatment regimens on hookworm cure rate and egg reduction rate.

Objective 3: To identify and evaluate environmental, social and cultural variables affecting hookworm infection, and cure rate and egg reduction rate of albendazole against hookworm.

 Mayuge, All parish
,
South Korea 2021-08-16 2024-08-16 1650 Age: P4 and P5 grade students (approximately 9-10 years old) Sex: an approximately equal number of both male and female Korea International Cooperation Agency (KOICA) Medical and Health Sciences Clinical Trial Degree Award
Violet Korutaro
ID: UNCST-2019-R000618
 IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Short title: ‘MOCHA’ (More Options for Children and Adolescents), DAIDS # 30070, IND # 138,754
REFNo: HS1512ES

To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents,To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents by evaluating: Safety and multiple dose PK of oral CAB through Week 4, Safety and multiple dose PK of CAB LA through Week 16, and to confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16,To confirm the dose and evaluate the safety, tolerability, acceptability, and pharmacokinetics (PK) of oral cabotegravir (CAB), long-acting injectable cabotegravir (CAB LA), and long-acting injectable rilpivirine (RPV LA) in virologically suppressed HIV‐1 infected children and adolescents aged 12 to <18 years.,
 Kampala, Kisenyi
Kampala, Mulago
Kampala, Kawaala
Kampala, Naguru
Kampala, Kitebi
 Uganda 2021-08-16 2024-08-16 155 This study will be conducted in Kampala among HIV‐1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral. These potential partic National Institute of Allergy and Infectious Diseases Medical and Health Sciences Clinical Trial Non-degree Award
Jonathan Kayondo
ID: UNCST-2021-R008325
 Multi-Centre, Prospective, Evaluation for Matrix equivalence of capillary whole blood finger-stick and fresh and frozen venous whole blood with the NxTekâ„¢ Malaria Pf Plus Rapid Test Device and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test Device for the Detection of Plasmodium Infections in Patients with Symptoms Suggestive of Malaria within the Lab and its intended use environment for CE IVDR.
REFNo: HS1587ES

This trial is part of the R&D Verification and Validation studies, to provide clinical matrix equivalence evaluation to support the conformity assessment procedure for the use of fingerstick and venous whole blood samples with Abbott’s NxTek™ Malaria Pf Plus and NxTek™ Malaria Pf/Pv Plus Rapid Test Devices, as performed by professional users, in accordance with WHO PQ TSS-3, WHO PQ Dossier, EU 2017/7461.

Primary Objective: Matrix Equivalence
To assess the matrix equivalence of:
a. Fresh CWBFS and Fresh VWB
b. Frozen VWB and Fresh VWB
when used with the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus by laboratory professionals (from hereon referred to as Lab operators) in a laboratory environment to support CE IVDR certification.

The test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using a VWB sample, will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using CWBFS sample from the same participant. In summary: Fresh CWBFS vs. Fresh VWB*. Likewise, the test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using VWB samples that have been exposed to 1x Freeze/Thaw cycle will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using fresh VWB samples from the same participant. In summary: Frozen VWB vs. Fresh VWB*

*indicates: Where Fresh VWB will be the comparator sample type.

The data obtained will be used in the application for CE IVDR certification and WHO PQ. Paired CWBFS and VWB samples will be taken from the same individuals for testing on both NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus RDTs.

Secondary Objective: Intended Users within the Intended Use Environment
Malaria RDTs are used outside of the laboratory for near patient testing (NPT)* by non laboratory healthcare workers with limited training. Thus the secondary objective of this study is to assess the perfromance of the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus results when used in its intended environment (NPT setting) by intended users (non laboratory healthcare workers with limited training) using CWBFS as the sample type.*see NPT definition Section 4.2-4.3 of protocol (or below sections on trial operator types and trial envitronment types).

 Kanungu, Market Cell
Wakiso, Maganjo
Wakiso, Central Ward
 Uganda 2021-08-16 2024-08-16 Section 5.2 of Protocol: Two arms- each kit minimum 90 Pf Positives, 26 Pv Positives, 116 Negatives All comers, febrile symptomatic patients of both sexes aged 15 years and above suspected of having malaria and seeking standard medical care at the sites. Abbott Diagnostics Korea Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Rhoda Wanyenze
ID: UNCST-2021-R013352
 PILOT OF A NETWORK-DRIVEN, ADVOCACY INTERVENTION TO PROMOTE CERVICAL CANCER SCREENING IN UGANDA (PHASE 3)
REFNo: HS1633ES

The proposed intervention development study seeks to improve cervical cancer screening in Uganda by engaging and training local public health researchers and program implementers, and empowering women living with cervical cancer risk (WLCCR), defined as women who have ever received CC screening procedures, to advocate for CC screening and early treatment among women in their social networks.
 Namayingo, Buyinja
 Uganda 2021-08-16 2024-08-16 40 index participants; 120 social network members This study represents phase 3 of the study that was earlier registered with UNCST. During this phase, we will aim to enroll women living with cervical cancer risk (hereafter referred to as the 'index participants'), defined as women who have ever been scr Glenn Wagner (RAND Corporation, USA) Medical and Health Sciences Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
 IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Version 3.0, dated 13 August 2020
REFNo: HS1356ES

Primary Objectives:
Cohort 1
1.To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents
2.To confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16
Cohort 2:
1.To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents
Secondary Objectives: Cohort 1
• To monitor maintenance of viral suppression through Week 16 in HIV-infected, virologically suppressed adolescents
• To evaluate the tolerability and acceptability of CAB LA through Week 16 in HIV-infected,virologically suppressed adolescents
• To evaluate the tolerability and acceptability of RPV LA through Week 16 in HIV-infected,virologically suppressed adolescents
Secondary Objectives: Cohort 2
• To assess safety of oral CAB + oral RPV followed by CAB LA + RPV LA through Week 48 in HIVinfected, virologically suppressed adolescents
• To evaluate repeat-dose pharmacokinetics of CAB LA + RPV LA through Week 24, and through
Week 48 in HIV-infected, virologically suppressed adolescents.
• To assess antiviral activity of CAB LA + RPV
 Kampala, Mulago
Kampala, Mulago 1
 Uganda 2021-08-11 2024-08-11 155 participants overall but MUJHU plans to enroll 18-25 participants HIV‐1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, National Institutes Of Health Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Performance Evaluation of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in Uganda
REFNo: HS1606ES

Main objective
To evaluate the field performance of the m-PIMATM HIV-1/2 VL plasma VL in identifying virological failure (VF) in adults on ART. The performance will be compared to standard PCR assays used at UNHLs and UVRI.
2.3.2 Primary objectives
I). To evaluate the diagnostic accuracy using the sensitivity, specificity, NPV, PPV, FPR and FNR of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in comparison to a reference assay of HIV-1 RNA PCR in identifying HIV-VF at the WHO recommended threshold of 1000 copies/ml for HIV-1 infected.
II). To determine the operational characteristics of the m-PIMAâ„¢ HIV-1/2 VL plasma assay, such as ease of-use of the assay using the standardized system usability scale (SUS) by laboratory and no laboratory personnel
III). To determine changes in turn-around time and ease of clinic workflow integration.
IV).To determine acceptability of the m-PIMAâ„¢ HIV-1/2 VL plasma assay by the study participants

 Kampala, Kampala
Buikwe, Buikwe
Kayunga, Kayunga
Mpigi, Mpigi Town Council
 Uganda 2021-08-11 2024-08-11 403 participants -Adult ART patients who are ≥18 years old on ART for ≥ 6 months will be approached for study participation. Historical controls will be used to compare the time to initiation of intensive adherence counselling (IAC) between the m-PIMA and the standard - Abott Diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Hannah Kibuuka
ID: UNCST-2020-R014355
 A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older
REFNo: HS1638ES

1. To assess, in participants who are SARS-CoV-2 naïve, the
clinical efficacy of the CoV2 preS dTM-AS03 vaccines for
the prevention of symptomatic COVID-19 occurring ≥ 14
days after the second injection.

2. To assess the safety of the CoV2 preS dTM-AS03 vaccines
compared to placebo throughout the study.
 Kampala,
Wakiso,
Mukono,
Uganda 2021-08-10 2024-08-10 800 Adults 18 years of age and older Sanofi Pasteur Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 An open label, Phase 2 study to evaluate the safety and immunogenicity of an Ad26.ZEBOV booster dose in Human Immunodeficiency Virus Positive (HIV+) adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen
REFNo: HS1350ES

• To assess the safety and tolerability of a Ad26.ZEBOV booster dose in HIV positive adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen.

• To assess humoral responses induced by the booster dose against EBOV glycoprotein (GP), as measured by Filovirus Animal Non-Clinical Group (FANG) Enzyme-Linked Immunosorbent Assay (ELISA) at 7 and 21 days.

 Masaka, NOT APPLICABLE
Lwengo, NOT APPLICABLE
Bukomansimbi, NOT APPLICABLE
Kalungu, NOT APPLICABLE
 Uganda 2021-08-04 2024-08-04 50 participants Participants must be healthy (based on physical examination, medical history, and clinical judgment) HIV positive adults who received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in the VAC52150EBL2002 trial and were aged ≥18 to ≤50 years at the tim London School of Hygiene & Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
 Determination of Adequate TUberculosis Regimen in Adults and adolescents hospitalised with HIV-associated severe immune suppression (Acronym: DATURA).
REFNo: HS1487ES

Primary objective: To estimate the impact of an intensified initial phase of tuberculosis (TB) treatment on mortality at 48 weeks among HIV-infected adults and adolescents hospitalised for TB with CD4 ≤ 100 cells/μL in comparison with the standard TB regimen. Secondary objectives: To estimate the impact of an intensified initial phase of TB treatment, in comparison with the standard TB regimen, on: ¥ Mortality at weeks 8 and 24 ¥ Adverse events, including: - All grade 3-4 events - Selected grade 2 events of interest - Drug-related adverse events - AIDS defining illnesses - Paradoxical TB-associated immune reconstitution inflammatory syndrome (IRIS) ¥ TB treatment success ¥ TB recurrence ¥ Antiretroviral treatment (ART) response in terms of virological success and immunological response ¥ Adherence to TB treatment and ART ¥ Peak plasma concentrations of rifampicin and isoniazid (and its N-acetyl-metabolite) at day 3, day 7 and week. ¥ Plasma concentrations of efavirenz and dolutegravir at week 4 (i.e. 2 weeks after the onset of ART)
Mbarara, Mbarara
 Uganda 2021-07-16 2024-07-16 1330 15-85years, All sexes, all tribes, ethnicities and religions Inserm-ANRS French National Institute for Health and Medical Research (Inserm) ANRS Infectious Emerging Diseases – Autonomous Agency of Inserm (ANRS) Medical and Health Sciences Clinical Trial Non-degree Award
Catriona  Waitt John
ID: UNCST-2019-R001068
 Implementation of a "bundle of care" to improve anticoagulation control in patients receiving warfarin in Uganda and South Africa
REFNo: HS1422ES

Primary objective is to evaluate whether implementation of warfarin bundle improves time in therapeutic range

Secondary objectives are:
-To evaluate whether implementation of the warfarin bundle improves time to achieving a therapeutic INR
-Whether implementation of the warfarin bundle affects the occurrence of adverse events(death, bleeding and thrombotic events)
-whether staff find the interventions contained in the bundle acceptable
-To explore patients' experiences and acceptability of the package of care, and
-Whether the bundle represents good value for money
 Kampala, Salaama
Kampala, Mulago
 UK 2021-07-09 2024-07-09 444 Adult patients (18 years or older),male or female newly initiated on warfarin for the first time University of Liverpool Medical and Health Sciences Clinical Trial Non-degree Award
Deborah  Ojiambo
ID:
Efficacy of Group Activity Adherence Counselling (GAAC) for Adolescents with Unsuppressed HIV viral load at three large HIV clinics in Uganda: Randomized controlled trial
REFNo: SS805ES

1.To examine the barriers such as behavior problems and mental health problems to adherence experienced by adolescents living with HIV.
2.To evaluate the efficacy of GAAC in addressing barriers to adherence among adolescents living with HIV.

3.To assess whether GAAC is associated with viral load suppression, among adolescents living with HIV compared to Standard Service Provision (SSP)
 Kampala, Mulago 1
Wakiso, Entebbe
 Uganda 2021-07-07 2024-07-07 300 The population for this study is school-going adolescents living with HIV (12-18 years) who received ART for at least 6 or more months at Mulago ISS, TASO Mulago, TASO Entebbe HIV clinics Makerere University Research and Innovation Fund (RIF) funded by Uganda government Social Science and Humanities Clinical Trial Non-degree Award
Susan  Nabadda
ID: UNCST-2020-R014331
 Diabetes Mellitus Tuberculosis and HIV multimorbidities among adult patients attending Kiruddu National Referral Hospital, Uganda Version 2 7/26/2020.
REFNo: HS1386ES

General Objective
The overall objective of this project is to determine the prevalence of DM among patients with either TB, HIV, and TB-HIV co morbidity. This will help to assess the prevalence of silent DM in these categories of patients.
Specific objectives

1. To describe the prevalence of DM among either TB patients or HIV patients or patients with both TB and HIV co morbidity attending the Kiruddu hospital outpatient clinics
2. To determine the factors associated with DM in patients with HIV alone, TB alone and HIV – TB co-infection.

 Kampala, Buziga
 Uganda 2021-06-29 2024-06-29 1000 Adults of 18 years and above, HIV-infected patients or TB patients receiving care at Kiruddu National Referral Hospital (patients with both TB and HIV will also be included) However, patients who will be critically ill and in need of emergency clinical c Beckton Dickinson and the United States Centers for Disease Control and Prevention (CDC), Uganda. Medical and Health Sciences Clinical Trial Non-degree Award
JUSTUS BARAGEINE KAFUNJO
ID: UNCST-2020-R014150
 COMPREHENSIVE REINTEGRATION ASSISTANCE FOR WOMEN WITH FEMALE GENITAL FISTULA: INTERVENTION PILOTING
REFNo: SS890ES

Aim 1: To understand the feasibility and acceptability of a pilot reintegration program for female genital fistula. Aim 2. To assess the acceptability of the pilot reintegration intervention to patients, intervention implementors. Aim 3. To assess the preliminary effectiveness of the pilot reintegration intervention.
 Kampala, MULAGO
,
Uganda 2021-06-24 2024-06-24 40 (30 women to participate in the intervention and indepth interview plus 10 stake holders Women aged 18 years and above or considered emancipated minors under Ugandan law who are undergoing genital fistula surgery. U.S. Eunice Shriver Kennedy National Institute of Child Health and Development. Social Science and Humanities Clinical Trial Non-degree Award
Mohammed Lamorde
ID: UNCST-2019-R001293
 Drug Interactions between Dolutegravir (DTG) and escalating-doses of Rifampicin (RIF) Study
REFNo: HS1376ES

The secondary objectives of the trial are to determine the safety and tolerability of the DTG/RIF combination, the PK of RIF, induction of PgP and CYP3A4 and effect of DTG on appetite,Primary Objective The primary objective of the study is to determine changes to the PK parameters of DTG when administered with standard, medium and high doses of RIF in HIV-negative, TB-monoinfected participants coming to the end of continuation TB therapy with standard doses of RIF and INH over a 10 week period,
 Kampala, Mulago 1
 Nigeria 2021-06-23 2024-06-23 18 Inclusion Criteria • Ability to give informed consent prior to participation • Willing and able to comply with all study requirements • Receiving standard doses of RIF and INH • HIV antibody negative • Male or non-pregnant, non-breastfeedin University of Liverpool Medical and Health Sciences Clinical Trial Non-degree Award
Irene Andia Biraro Rebecca
ID: UNCST-2019-R001475
 A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People with Diabetes.
REFNo: HS1112ES

Primary objective:
To assess the efficacy of preventive therapy with a 12-week course of rifapentine and isoniazid (3HP) against the development of probable or definite TB disease over 24 months in people with Diabetes Mellitus (DM) who are latent TB infection (LTBI) test positive.
Secondary objectives:
• To assess the efficacy of 3HP against the development of possible, probable or definite TB disease over 24-40 months in people with DM who are latent tuberculosis infection test positive
• To compare the proportions who complete treatment between arms
• To compare the occurrence of adverse events between arms
• To compare the rate of TB or death between arms
• To compare the overall mortality rate between arms
• To explore the efficacy of 3HP against development of probable or definite TB in those who are LTBI test positive, across the following sub-groups, separately: study site (n=3); age groups; duration of DM; level of glycaemic control (baseline HbA1C) and body mass index (BMI).
• To assess the efficacy of 3HP against development of probable or definite TB, in two restricted analyses: TST positive and IGRA positive participants.
• To carry out sub-studies including i) an economic modelling and cost effectiveness study, ii) a cohort study of those who are IGRA and TST negative a baseline, iii) a cross-sectional study of HIV and TB prevalence and DM phenotype, (iv) evaluation of point-of care (POC) testing for LTBI, and computer-assisted X-ray, (v) a public health study of patient management, and v) future genetic studies.

Kampala, Munyonyo
Wakiso, Kasangati
Kampala, Rubaga
 Uganda 2021-06-18 2024-06-18 1500 Inclusion criteria I. Enrolled in diabetes care with a history of DM and current use of anti-diabetic medication (‘known DM’); OR in the absence of anti-diabetic medication an HbA1c of ≥6.5% (48 mmol/mol) or a fasting venous plasma glucose of ≥7. National Institute for Medical Research, Mbeya Tanzania Medical and Health Sciences Clinical Trial Non-degree Award
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