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  
Bruce Kirenga J
ID: UNCST-2019-R001460
 SAFETY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF HERBAL PRODUCTS FOR THE TREATMENT OF ACUTE RESPIRATORY VIRAL INFECTIONS INCLUDING SARS-COV2 IN UGANDA; PHASE 2A OPEN LABEL CLINICAL TRIAL
REFNo: HS2548ES

The general objective is to assess the safety, pharmacokinetics and preliminary efficacy of TazCoV and Vidicine for the treatment of acute respiratory viral infections (SARS-CoV2, RSV and Influenza A/B) in Uganda.
Specific objectives
1. To determine the safety and pharmacokinetics of TAZCOV and Vidicine herbal products among adult patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza A/B

2. To determine the extent of SARS-CoV2, RSV and Influenza A/B viral clearance among adult patients with acute viral respiratory infection treated using TAZCOV and Vidicine

3. To establish time-to-remission of symptoms among patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine

4. To evaluate disease progression among patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine
 Kampala, Mulago
 Uganda 2022-11-29 12:38:24 2025-11-29 510 The maximum individual participant trial duration will be 90. The actual time the trial will last will depend on the rate of enrollment. It is estimated that the trial will take 18 months. days. The Government of Uganda through the Ministry of Science, Technology and Innovation-Office of the President (STI-OP) Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 Ring vaccination trial to evaluate the efficacy and safety of Sudan ebolavirus vaccines in Uganda
REFNo: HS2574ES

Probable SUVD and death from confirmed SUVD ,main secondary objective is to assess the safety of the vaccine by monitoring weekly for 21 days any adverse reactions to vaccination and any other serious adverse events,The primary analysis will be of laboratory-confirmed SUVD (from samples taken either while living, or within 48 hours of death),
 Uganda 2022-11-23 15:04:05 2025-11-23 N/A All active contacts of Ebola viral disease, Participants aged 6 years and above, all tribes, all genders World Health Organisation and the Ministry of Health Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 A multiple arm, multiple stage (MAMS), phase 2B/C, open label, randomized, controlled platform trial to evaluate experimental arms including an increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin and sutezolid, in adult subjects with newly diagnosed, smear-positive pulmonary tuberculosis
REFNo: HS2644ES

Primary Efficacy Objective:
Rifampicin- containing experimental arms (arms 1,2)
To evaluate whether one or more of two experimental regimens based on
optimized dose rifampicin, optimized dose of pyrazinamide, and moxifloxacin
given for 12, respectively 17 weeks, are superior to standard treatment given for
26 weeks, as assessed by time to sputum culture conversion to negative in liquid
media.
Sutezolid-containing experimental arm (arm 4)
 To evaluate whether the efficacy of an experimental regimen composed of
sutezolid, delamanid, bedaquiline, and moxifloxacin given for 17 weeks is
superior to standard treatment given for 26 weeks, as assessed by time to
sputum culture conversion to negative in liquid media.
Secondary Objectives This study’s secondary objectives are:
Efficacy
 To assess treatment efficacy based on proportion of patients with relapse
free outcome at 12 months after randomization.
 To assess treatment efficacy based on the rate of decline of bacterial load
measured by the Molecular Bacterial Load Assay
 To rank the relative efficacy of the experimental four-drug combinations
for the treatment of pulmonary tuberculosis within the first twelve weeks
of treatment, and select the most efficient experimental treatment
regimen or regimens for further development.
Safety and Tolerability
To assess the frequency, severity, and type of adverse events (AEs), and AErelated
treatment discontinuations.
Pharmacokinetics
To describe the pharmacokinetics of the drugs and doses used, and to assess
possible relationships between pharmacokinetic parameters of the various drugs and between pharmacokinetic parameters and participant characteristics.
Pharmacodynamics To describe relationships between pharmacokinetic parameters on the one hand and efficacy and safety endpoints on the other hand.
 Kampala, Kawempe
 Uganda 2023-04-11 15:27:11 2026-04-11 360 Adults A total of up to 360 adult (≥ 18 years of age) participants will be enrolled. In case of a high number of dropouts or non‐evaluable participants, it may be necessary to recruit more participants into the study. Also, if the stage 2 starts later than stage 1, it will be necessary to increase the number of control arm participants to achieve a 1:1 ratio of concomitantly recruited control and arm 4 participants (see sample size considerations). Both males and females regardless of tribe as long as an ICF of that particular language spoken by the participant is available, will be enrolled. LMU Klinikum Marchioninistr. 15, 81377 Munich Germany Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SOLIDARITY TRIAL-A phase I/II Randomized Placebo controlled trial to evaluate the Safety and Immunogenicity of Sudan Ebolavirus in Uganda
REFNo: HS3190ES

Phase I (rVSV-SUDV)
1. To determine the safety of rVSV-SUDV candidate SUDV vaccine among adult healthy volunteers in Uganda.
2. To determine the immunogenicity of rVSV-SUDV candidate SUDV vaccine.

Phase II (ChAdox1, CAd3 and rVSV-SUDV)
Primary objectives
1. To determine the safety of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccines among healthy volunteers and persons with stable comorbidities.
2. To determine the immunogenicity of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccines.
Secondary objectives
1. To determine the durability of SUDV-specific induced immune responses following vaccination.
2. To determine the factors associated with optimal vaccine-induced immune responses.
3. To determine the putative cross reactivity by the SUDV vaccine candidates against other ebolaviruses (e.g. Bundibugyo ebolavirus (BUDV) and EBOV).

Exploratory objectives
1. To determine the effect of SUDV vaccines on host gene expression.
2. To determine the T and B cell specific responses and immune profiling in response to vaccination.
3. To determine the effect of SUDV vaccines on the host metabolome.
4. To determine the effect of SUDV vaccines on host innate immune responses.

 Kabarole, Fort portal
Kampala, Mulago I
Kayunga, Kayunga
Mbarara, Rubindi
Wakiso, Nkumba
Mubende, Kikanddwa
Masaka, Kabonera
 Uganda 2024-02-26 13:31:25 2027-02-26 2121 participants will be recruited in phase II and phase I will recruit 250 participants healthy volunteers both male and females will be recruited in the study regardless of the ethnic group they belong to. The participants will recruit people aged 6-65 in to phase I and phase to World Health Organization and Ministry of Health Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SMART (Smallpox vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
REFNo: HS4726ES

Co-Primary objectives Co-primary: 1) To assess the effectiveness of the Smallpox vaccine in preventing RT-PCR confirmed Mpox infection among contacts of confirmed Mpox infection 2) To assess the effectiveness of the Smallpox vaccine in reducing the severity of symptoms; measured as symptom severity score, based on 12 symptom items (16) each assigned a score of 0 to 5 for a total measure of 0 to 60. These co-primary objectives will be evaluated during the first 28 days after randomization.
 Kisoro, Rubanda
 Uganda 2024-09-27 14:06:23 2027-09-27 1560 10 years and above, Males and females, and all tribes residing within the study area that meet the inclusion criteria will be included in the study. McMaster University Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SURVEY, SAFETY AND EFFICACY OF HERBAL PRODUCTS USED FOR MALARIA PROPHYLAXIS AND TREATMENT IN UGANDA.
REFNo: HS5468ES

To conduct a survey of herbal medicinal products used for malaria prophylaxis and treatment, evaluate their safety and prophylactic efficacy among school-age children (8-15yrs) in Kibuku district, Uganda.
1. To identify herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
2. To evaluate the artemisinin content of herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
3. To determine the antiplasmodial activity (IC50) of herbal medicinal products used for malaria prophylaxis and treatment in Uganda.
4. To evaluate the safety of herbal medicinal products used for malaria prophylaxis among school age children (8-15 years) in Kibuku district in eastern Uganda.
5. To determine malaria incidence among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku district in eastern Uganda.
6. To determine prevalence of parasitaemia among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku in eastern Uganda.

 All Districts, NA
Kibuku,
Uganda 2025-03-14 19:08:33 2028-03-14 222 participants for the trial (111 per study arm) 8 to 15 years of age, both male and female, all tribes accessible. The Government of Uganda through the Science, Technology, and Innovation Secretariat - Office of the President (STI-OP) Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 Safety, preliminary efficacy, and Pharmacokinetics of Herbal/Natural/ Traditional therapeutic products for the management of Diabetes Mellitus in Uganda.
REFNo: HS6530ES

Main Objective
1. To evaluate the safety, effectiveness and pharmacokinetics of 3 selected NDA- notified herbal/natural/traditional therapeutic products in Uganda, designated IMP1, IMP2, and IMP3.
2. To explore the experiences of innovators, researchers, implementers, and participants involved in this study on the innovation and scientific evaluation of natural therapeutics in Uganda.

Specific Objectives
1. To determine the efficacy of selected NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the treatment of diabetes mellitus in adult patients in Uganda
2. 2. To assess the effect of the selected NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) on specific cardio-metabolic characteristics of adult patients with DM in Uganda.
3. To assess clinical and laboratory adverse events associated with selected NDA- notified herbal/natural/traditional therapeutic products, specifically IMP1, IMP2 and IMP3 in adult patients with DM in Uganda.
4. To investigate the pharmacokinetic profile(s) of NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the management of DM.
5. To explore the experiences of innovators, researchers, implementers, and participants involved in this study on the innovation and scientific evaluation of herbal/natural/traditional therapeutics in Uganda.e the pharmacokinetic profile(s) of NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the management of DM.

Uganda 2025-12-01 14:19:22 2028-12-01 424 Objective 1- 4 Persons with a new or known diagnosis of diabetes mellitus Objective 5 Personnel working in research programs, including: Investigators, Program managers, Clinical staff Innovators of herbal/natural/ traditional therapeutic products purposed for diabetes mellitus management. Objective 1-4 Adult (≥18 years) patients with recently diagnosed diabetes mellitus (diagnosis made in the preceding three months) Objective 5 Individuals who have worked with the CONAT program as investigators, program manager, or clinical staff for at least six months. Innovators of herbal/natural/ traditional products for diabetes mellitus whose product will be found during the survey. Government of Uganda-STI-OP Medical and Health Sciences Clinical Trial Non-degree Award
Byamah Mutamba Brian
ID: UNCST-2022-R011124
 Strengthening Care in collaborAtion with People with lived Experience of psychosis in Uganda (SCAPE-U
REFNo: HS2327ES

General objective
To assess the impact of SCAPE-U on individual, family members’ and health system outcomes, and evaluate trial procedures to determine the optimal design for a future fully-powered cluster randomised controlled trial (RCT).
Specific objectives
1. To assess the feasibility and acceptability of SCAPE-U from the perspective of people with lived experience of psychosis, their family members and primary and community care providers.
2. To demonstrate proof-of-concept for the benefit of SCAPE-U for service users (i.e., patients with psychosis receiving primary care services) and their families, including changes in psychosis symptoms, quality of life, frequency of hospitalization and the potential impacts on family members.
3. To determine changes in health systems outcomes in terms of primary care provider knowledge, attitudes, competency in psychosis diagnosis and management, as well as accuracy of diagnosis and fidelity to treatment guidelines in actual care settings.
4. To evaluate trial procedures, including costing, recruitment and retention, and data collection protocols, to determine the optimal design for a future fully-powered cluster RCT

 Kampala, All parishes
Wakiso, All parishes
 Uganda 2022-09-21 21:32:50 2025-09-21 120 persons diagnosed with Psychosis There will be five categories of participants in this study: Persons with lived experience of psychosis (SCAPE-U facilitators) – Approximately 10-20 people with lived experience of psychosis will be recruited from prior YouBelong Uganda programs to be trained in PhotoVoice as SCAPE-U facilitators in the SCAPE-U arm. These people with lived experience of psychosis will require a diagnosis of a psychotic disorder confirmed by a mental health professional (psychiatric clinical officer or psychiatrist). Mental health professionals will be required to evaluate PLWP for any health or functional impairment that could jeopardize their safe participation as well as seek their consent. Currently participating in treatment (taking antipsychotics, receiving psychosocial support, or both) is not an exclusion criterion. We plan to draw SCAPE-U facilitators from YouBelongHome beneficiaries. The YBH intervention comprises two unique phases: 1) a pre-discharge assessment which provides a detailed description of an individual’s general health and mental health history; individual goals and aspirations; a social demography of the individual and his/her family with particular emphasis on potential barriers to and supports for individual and family well-being; and the education and awareness level of the local community in mental health; this first phase is completed in a 2 to 3 weeks and 2) the second phase is the post-discharge community-based strengthening, informed by the pre-discharge assessment, that focuses on both empowering the family as an active agent in the returned person’s recovery and connecting the person with SMI and family to the support of friends, extended family, community, and work. This phase includes both face to face and phone engagements over a 12-week period. In response to the COVID-19 pandemic, YBU has modified the pre and post discharge process from a 16 week to a 5-week intervention, to allow for a higher rate of return and resettlement of patients, while ensuring that those patients in need of complex mental health and psychosocial care still receive the unmodified YBH pre and post discharge version of care. They will meet the following selection criteria: a) completion of the YBH program, b) confirmed diagnosis of a primary psychotic disorder (e.g., schizophrenia) by a psychiatrist or PCO, c) provision of informed consent, d) fluency in the local language (Luganda), e) good functioning with respect to performance of daily chores, engagement with family members, comprehension and community participation as assessed by the YBH team, and f) a supportive family member. We will also maintain professional conduct guidelines to monitor experience of clients during home visits and other interactions. Primary care providers – Primary care providers who have been selected by the in-charge of the health facility to participate in the study, will be trained in mental health service delivery with the mhGAP-IG. Two providers will be selected per facility and there are no exclusion criteria, for an estimated 70 primary care providers per arm. At the primary care provider level, all primary care providers being trained in mental health services will be eligible for participation. Community health workers – Five community health workers (VHTs) who are affiliated to the health facilities where PHWs receive training in mhGAP and have been selected by the in-charge of the health facility to participate in the study. Service users (main intended beneficiaries) – The primary intended beneficiaries of study interventions are patients receiving treatment for psychoses. At the patient level, any patient presenting to HC-II, III, or IV receiving a diagnosis of psychosis from primary care providers will be eligible for participation in this study. The goal is to have 60 patients per arm for the two arms (120 patients total). At the patient level, any patient presenting to HC-II, III, or IV receiving a diagnosis of psychosis from primary care providers will be eligible for participation in this study. Service user inclusion criteria: 1. Persons diagnosed with psychosis at a primary health care facility in Kampala/Wakiso District; 2. Ability of the patient or responsible surrogate to consent to study enrolment and procedures; 3. Persons eligible for outpatient management of psychosis. Exclusion criteria will be 1. Persons diagnosed with psychosis requiring inpatient management/services; and 2. Persons for whom consent for participation in the study cannot be obtained. Family members of service users – At least one primary carer to a participating service user will be identified in order to collect outcome data from the carer Wellcome Trust, UK Medical and Health Sciences Clinical Trial Non-degree Award
Jude Byansi Zziwa
ID:
DEVELOPING A FRAMEWORK FOR PROVIDING SUSTAINABLE SANITATION SERVICES IN URBAN SCHOOLS IN LOW- AND MIDDLE-INCOME COUNTRIES: A CASE OF TWO CITIES IN UGANDA
REFNo: SIR254ES

(iv) To establish the effect of the school centered sanitation service framework on human faecal exposure pathways in urban schools of LMICs.,To ascertain how the key factors in objective (ii) above, interact to provide sustainable sanitation services in city schools,To establish factors sustaining sanitation service provision in city schools,To determine the status of sanitation service provision in city schools ,The general objective of this study is to develop a sanitation management framework that will contribute to sustainable service provision in urban schools of Low- and Middle Income Countries (LMICs).,
 Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
 Uganda 2023-11-20 15:27:51 2026-11-20 2,434 participants The pupil population from age 9 to 25 years, Teacher population from age 23 to 60 years, Other stakeholders will be adults. Male and female participants will be balanced. Citywide Inclusive sanitation Program Engineering and Technology Clinical Trial 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
Cissy  Kityo
ID: UNCST-2021-R013663
 ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)
REFNo: HS1813ES

1.1 Co-Primary Objectives 1.1.1 Phases II and III: To evaluate safety of the investigational agent. 1.1.2 Phase II: To determine efficacy of the investigational agent to reduce the duration of COVID-19 symptoms through study day 28. 1.1.3 Phase II: To determine the efficacy of the investigational agent to increase the proportion of participants with nasopharyngeal (NP) SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) at study days 3, 7, and 14. 1.1.4 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study day 28. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic. 1.2 Secondary Objectives 1.2.1 Phases II and III: To determine whether the investigational agent reduces a COVID-19 Severity Ranking scale based on COVID-19-associated symptom burden (severity and duration), hospitalization, and death, through study day 28. 1.2.2 Phase II and III: To determine whether the investigational agent reduces the progression of COVID-19-associated symptoms. 1.2.3 Phase II and III: To determine if the investigational agent reduces levels of SARS-CoV-2 RNA in NP swabs. 1.2.4 Phase III: To determine the efficacy of the investigational agent to increase the proportion of participants with NP SARS-CoV-2 RNA below the LLoQ at study day 3. 1.2.5 Phase II: To determine the pharmacokinetics of the investigational agent. 1.2.6 Phase II: To determine efficacy of the investigational agent to obtain pulse oximetry measurement of ≥96% through day 28. 1.2.7 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study week 72. 1.2.8 Phase III: To evaluate if the investigational agent reduces the time to sustained symptom resolution through study day 28.
Wakiso,
Mpigi,
Mukono,
Uganda 2021-11-22 2024-11-22 The phase II evaluation will enroll approximately 110 participants per investigational agent (and 110 on placebo) (this includes all participants enrolled under previous protocol versions, irrespectiv Outpatient adults (≥18 years) with a documented positive SARS-CoV-2 molecular (nucleic acid) or antigen test from a sample collected ≤240 hours (10 days) prior to study entry and with ≤7 days of symptoms of COVID-19 at study entry, plus the presence The National Institute of Allergy and Infectious Diseases, Division of AIDS/NIAID/NIH/DHHS, Rockville, Maryland 20892 USA Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 Platform Assessing Regimens And Durations In a Global Multisite consortium for TB. A Seamless Phase 2B/2C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis
REFNo: HS3044ES

Phase 2C: Amongst regimens selected for progression from phase 2B, to further evaluate the safety profile and to identify the optimal treatment duration (between 8 and 16 weeks) based on unfavourable outcome to support advancement to future Phase 3 trials.,Phase 2B: To identify regimens with acceptable safety profile that have the greatest potential, based on assessment of quantitative sputum liquid culture and treatment failure/relapse to progress to investigation of optimal treatment duration in Phase 2C.,To identify novel drug regimen(s) with acceptable safety profile, non-inferior efficacy and shortened treatment duration compared to the standard-of-care 24-week HRZE regimen that could be used to treat people with rifampicin susceptible and rifampicin resistant TB.,
 Kampala, Kampala
Wakiso, Kampala
Mukono, Kampala
Mpigi, Mpigi
 Uganda 2023-12-01 17:56:07 2026-12-01 Up to 2500 overall will be enrolled, 700 in phase 2B and 1800 in phase 2C. An estimate of 165 patients in total for Uganda sites (60 in phase 2B and 105 in phase 2C) and about 30 patients for JCRC Lubowa in phase 2B and 55 patients in phase 2C. Adults ≥18 years with newly diagnosed pulmonary TB will be enrolled University College London Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB
REFNo: HS3834ES

1.2 Secondary Objectives 1.2.1 Phase 2a and 2b: To evaluate the proportion of participants with a quantifiable RS ratio after therapeutic vaccination with ID93 + GLA-SE compared to placebo. 1.2.2 Phase 2a: To evaluate the kinetics of cellular immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.3 Phase 2a: To evaluate the kinetics of humoral immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.4 Phase 2a: To evaluate innate immune changes in response to ID93 + GLA-SE through 2 weeks post second dose of study product. 1.2.5 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE, to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, in subgroups defined by: Hard-to-treat phenotype and not hard-to-treat phenotype, where hard-to-treat phenotype is defined as smear Grade ≥3 and cavitary disease on chest radiograph at TB diagnosis.1.3 Exploratory Objectives 1.3.1 Phase 2a: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to: • The safety and immunogenicity of ID93 + GLA-SE in participants living with and without HIV. • The quantitative RS ratio at time points relative to vaccination and TB treatment as indicated in the Schedule of Evaluations (SOE). • The magnitude and quality of immune responses with respect to the composition of the intestinal microbiota. 1.3.2 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, adjusted for • Pharmacokinetics (PK) assessments of first-line TB drugs (exposure) during TB treatment as per the SOE. • Levels of participant adherence to standard of care (SOC) TB treatment measured using self-reporting and urine acetyl-isoniazid (AcINH) from start to end of TB treatment. 1.3.3 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, stratified by bacterial burden at start of TB treatment. 1.3.4 Phase 2a and 2b: To develop the composite predictive model of TB drug response by using measures of adherence, drug exposure (PK), immune response, gut microbiota, and participant phenotype. 1.3.5 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to proportion of participants with sputum culture conversion at baseline at time of randomization and at Step 2, Days 30, 120, and 150, which are approximately 2, 5, and 6 months after start of TB treatment. 1.3.6 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to cumulative relapse from end of TB treatment up to end of study follow-up, that is, Step 2, Days 420, 450, 480, and 510, for Groups 1, 2, 3 (&5), and 4 (&5), respectively. 1.3.7 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to lung function and health-related quality of life, as measured by spirometry and the St. George’s Respiratory Questionnaire. 1.3.8 Phase 2a and 2b: To compare the within-person change in lung function tests over time from the first dose of therapeutic vaccination with ID93 + GLA-SE to placebo. 1.3.9 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to resolution of transcriptomic biomarkers of TB disease. 1.3.10 Phase 2b: To identify correlates of protection for unfavorable TB outcomes. 1.3.11 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes among participants living with and without HIV. 1.3.12 Phase 2a and 2b: To conduct analyses related to furthering the understanding of TB, HIV, immunology, vaccines, and clinical trial conduct.,1.1 Primary Objectives 1.1.1 Phase 2a and 2b: To evaluate safety of a two-dose ID93 + GLA-SE vaccine regimen administered 60 days apart on Step 2, Days 0 and 60, with TB treatment administered, at approximately: 1.1.1.1 Months 4 and 6 after start of TB treatment (Group 1) 1.1.1.2 Months 3 and 5 after start of TB treatment (Group 2) 1.1.1.3 Months 2 and 4 after start of TB treatment (Group 3 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.1.4 Months 1 and 3 after start of TB treatment (Group 4 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.2 Phase 2a and 2b: To determine if therapeutic vaccination with ID93 + GLA-SE will increase the magnitude of vaccine-specific cellular responses compared to placebo at 2 weeks post second dose of study product. 1.1.3 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes (treatment failure, TB recurrence, or death due to TB) at Day 540 after study entry, which is approximately 18 months after start of TB treatment (Group 5 combined with either Group 3 or Group 4, depending on which vaccination schedule is selected for Group 5).,
 Kampala,
Uganda 2024-06-05 17:42:17 2027-06-05 100 Individuals with or without HIV, 18 years or older male or female (any tribe) with bacteriologically confirmed rifampicin-susceptible pulmonary TB receiving locally provided SOC TB treatment. Enrollment of participants living with HIV will be capped at 20% in each group. National Institute of Allergy and Infectious Diseases Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-Acting Combination Therapy Studies.
REFNo: HS4452ES

The secondary objective is to assess the long-term safety and tolerability of CAB LA + RPV LA by evaluating the incidence of serious adverse events (SAEs), pregnancies, adverse events (AEs) leading to discontinuation of CABLA +RPV LA, and AEs considered to be related to the study intervention.,The primary objective of the study is to provide continued CAB LA + RPV LA access to participants who were enrolled and treated with CAB LA + RPV LA in the parent studies, and who, at the time of roll-over, experience and are expected to continue to experience clinical benefit from this treatment.,
 Wakiso, Katabi
Wakiso, Lubowa
Kampala, Mulago
Kabarole, Buyinga
Uganda 2024-08-06 17:32:50 2027-08-06 710 in Uganda Virologically suppressed adults who have had a detectable HIV viral load in prior 2 years of taking first-line ART or who have disengaged from HIV care. Janssen-Cilag International NV Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 ACTG NEW WORK CONCEPT SHEET (NWCS) 575: Evaluation of biomarkers to predict TB-IRI
REFNo: HS4876ES

1. Determine whether higher levels of a set of biomarkers in people with HIV and tuberculosis prior to ART initiation may predict the development of TB-IRIS, particularly severe IRIS requiring corticosteroid treatment
2. Assess whether these biomarkers decrease between study entry and ART initiation in the deferred arm (i.e. with more prolonged anti-tuberculous therapy duration)
3. Determine whether these biomarkers can be predictive of other severe outcomes especially deaths.

 Uganda 2024-09-11 14:10:40 2027-09-11 1,000 A5221 participants were National Institute of Allergy and Infectious Diseases (NIAIDS) Medical and Health Sciences Clinical Trial Non-degree Award
Clovice Kankya
ID: UNCST-2020-R010154
 Capacitating One Health in Eastern and Southern Africa (COHESA)
REFNo: SS1482ES

To understand One Health performance, capacity, and bottlenecks within Uganda,To understand Current One Health Research and Innovation within Uganda,To understand One Health challenges, gaps and capacities within Uganda,
 Uganda 2022-10-27 9:26:54 2025-10-27 15 Key Informant Interviews, 15 people per workshop. Individuals and organizations contributing to One Health in both public and private sectors across Uganda. European Union Social Science and Humanities Clinical Trial Non-degree Award
Christine  Muhumuza
ID: UNCST-2023-R008646
 Improving Family Wellness for Couples in Central Uganda 2024-2029
REFNo: HS5523ES

The study aims are to:

(1) In a cluster randomised trial, compare the efficacy of the FH=FW intervention vs. a time/attention matched comparator intervention at increasing modern contraceptive use and reducing unintended pregnancy among couples with an unmet need for family planning through 24-months, and identify potential mediators of the intervention effect.

(2) Determine the intervention’s effect on, and determinants of, contraceptive continuation.

(3) Through a mixed-methods process evaluation, explore factors affecting the implementation of the intervention in order to improve feasibility, acceptability, and the likelihood of future adoption and sustainment
 Kalungu, Kalungu
Gomba, Kinoni
Mpigi, Bulunda A
Kalungu, Lukaya
Gomba, Kisozi
Mpigi, Muduma
Kalungu, Kabungo
Kalungu, Bbaala
Kalungu, Kabale
Kalungu, Kalungi
Kalungu, Kasambya
Kalungu, Kabungo
Gomba, Bulwadda
Gomba, Kasaka
Gomba, Kyayi
Gomba, Bukalagi
Gomba, Mpenja
Gomba, Ngomanene
Mpigi, Bunjako
Mpigi, Mitala-Maria
Mpigi, Butoolo
Mpigi, Kampiringisa
Mpigi, Katende
Mpigi, Sekiwunga
Mpigi, Kitakyusa
Mpigi, Nsamu/Kyali
Mpigi, Bujuuko/Bulamu
Mpigi, Nindye
 Uganda 2025-02-20 17:09:28 2028-02-20 We will sample 4 health centers (clusters) in each of the 3 districts. We expect that the 12 clusters will yield ~1704 participants (852 couples) across the two study arms. Married men and women (couples) aged 18-49 of any tribe in the selected districts. National Institute of Child Health and Development (NICHD), grant number: R01HD113806 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
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
 REDUCING MORTALITY IN ADULTS WITH ADVANCED HIV DISEASE (REVIVE)
REFNo: HS2892ES

To determine whether azithromycin is effective in reducing the incidence of new infection compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is effective in reducing mortality and hospitalisation at early and late timepoints (4weeks and 24weeks) compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is an effective and safe intervention to reduce excess mortality in adults with advanced HIV (CD4 ≤ 100 cells/mm3). ,
 All Districts, Not applicable
 Uganda 2023-09-27 17:43:49 2026-09-27 8000 18 years and above, all sexes and all tribes Population Health Research Institute (PHRI) Canada Medical and Health Sciences 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
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