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  
Esther Cathlyn  Atukunda
ID: UNCST-2022-R009265
 Evaluating Healthy Families PrEP: an intervention to promote PrEP use during periconception, pregnancy and postpartum periods for women in rural Uganda
REFNo: HS6117ES

1. Adapt Healthy Families-PrEP (HF-PrEP) to community clinics in Mbarara and Sheema Districts, Uganda to include postpartum women guided by our conceptual framework and the Consolidated Framework for Implementation Research (CFIR

2. Test Healthy Families-PrEP intervention effectiveness in a cluster-randomized control trial in Ugandan community health centers (HCs)

3. Determine incremental cost-per-person participating in Healthy Families-PrEP and estimate cost-effectiveness per incident HIV infection averted among women and their infants.
 Mbarara, All parishes
Sheema, All parishes
 Uganda 2025-07-09 16:14:46 2028-07-09 approximately 700 women There will be two groups of participants engaged for these studies: 1) women ages 18-45 years, in periconception, pregnant, and postpartum periods seeking health services from the community health centers 2) healthcare providers, administrators, and Ministry of Health officials National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Pauline Amuge Mary
ID: UNCST-2023-R005532
 LC-REVITALIZE – A Long Covid Repurposed Drug Study
REFNo: HS6370ES

-To assess the efficacy of repurposed drugs compared to their
respective placebos in reducing standardized symptom severity scores
in participants with Long Covid.
-To compare the symptom burden (e.g., anxiety, depression, overall
well-being) in participants with Long Covid treated with repurposed
drugs versus their respective placebos.
- To assess whether symptom burden worsens in participants with Long
Covid treated with study drugs versus placebo, specifically when
symptoms are reported across multiple scales.
- To assess changes in exercise capacity over time of participants with
Long Covid treated with study drugs versus their respective placebos.
- To measure specific Long Covid pathophysiological biomarkers of study
drugs versus their respective placebos.

 Wakiso, Sabagabo
 Uganda 2025-09-12 17:00:13 2028-09-12 384 Adults, male and female with Long COVID Dr. Douglas D. Fraser- Western University Medical and Health Sciences Clinical Trial Non-degree Award
Robert Kalyesubula
ID:
Effectiveness of a community health worker delivered care intervention for hypertension control in Uganda: a stepped wedge, cluster randomized control trial.
REFNo: HS1917ES

To assess the effectiveness of a CHW-delivered intervention for hypertension control in Uganda.,
 Nakaseke, Kigegge, Bulwadda, Mifunya, Kyamutakasa, Kasambya, Kasagga, North Ward. East Ward. Namilali, Kivule Central Ward
 Uganda 2022-02-10 2025-02-10 900 Hypertensive patients, 18 years and above, attending Nakaseke hospital or Life Care NCD clinics, and residing either in Nakaseke town council, Nakaseke Subcounty or Kasangombe. Else Kroner Fresenius Stiftung Medical and Health Sciences Clinical Trial Non-degree Award
Robert Kalyesubula
ID:
Human-centered design to adapt and inform an integrated chronic disease management program in Uganda using mobile payment services. (Acronym: IMPEDE CVD)
REFNo: HS2445ES

1)To understand patient and provider perspectives on the potential and acceptability of financing schemes and mHealth interventions aimed at strengthening behavior in relation to ideal drug availability and uptake among NCD patients (Work Package (WP) 1a).
2)To develop together with end-users a prototype for a mobile phone-based solution (including mobile-based nudges) to increase the availability and uptake of NCD drugs (WPs 1b, and 2).
3)To test the prototype, establishing proof of concept, and to assess end-users’ experiences interacting with two versions of the prototype (comparing two saving models), including how users make and evaluate payment management decisions, in preparation for a subsequent study (WP 3).
 Nakaseke, Semuto
Uganda 2022-10-20 18:01:35 2025-10-20 For the quantitative Studies, interview will be conducted until saturation; For the quantitative study (Trial), 380 participants will be included in the study The respondent groups for this study include medical health care providers (CHWs, medical doctors, clinic staff throughout all work packages), community members and key stakeholders (religious and local leaders, members of pooled financing schemes, academics (WP1 and 2)), clients (adults aged 18 years or older who regularly seek care in the study facility for diagnosed hypertension and diabetes (WP1-3), and decision makers (policymakers, MoH representatives, Health insurance (WP1)), as their attitudes, experiences, knowledge, and behaviors are explicitly within the target of the research question. For WP3, we also include study team members involved in intervention design, implementation, and evaluation processes as respondents. This study is funded through the German Alliance of Global Health Research. Medical and Health Sciences Clinical Trial Non-degree Award
Sylvia Kusemererwa
ID: UNCST-2019-R001717
 A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises
REFNo: HS5607ES

To assess the efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without
hydroxyurea (HU)/hydroxycarbamide (HC) , on VOC rate in Sickle Cell Disease (SCD) patients aged 12 years and older who experience frequent vaso-occlusive crises (VOCs)
Primary Objective
1. To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCP managed (including VOCs leading to management at a health care facility or those via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
Secondary Objectives
1. To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without
hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).
2. To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:
 VOCs that are HCP-managed at a health care facility
 VOCs that are HCP-managed via remote consultation
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 VOCs that are self-managed without recommendations from HCP during the event
 VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event
 Masaka, Masaka
 Uganda 2025-04-02 8:58:47 2028-04-02 20 A total of 10-20 participants will be recruited at the MRC/UVRI and LSHTM Uganda Research Unit site. Recruitment will be competitive across sites and countries. Participants will be recruited through referrals from the sickle cell clinic at the Masaka Regional Referral Hospital. The clinic has a total of about 600 patients. The site will recruit participants according to the main study protocol using the inclusion and exclusion criteria stated. They will collect detailed locator information including addresses, telephone contact, and next of kin to facilitate phone and/or physical tracing during the follow-up phase of the study. LSHTM Medical and Health Sciences Clinical Trial Non-degree Award
Robert Ssekitoleko
ID: UNCST-2019-R001716
 A Feasibility and Safety Study of the KeySuite Laparoscopic Devices for Cancer Diagnosis in Uganda
REFNo: SIR493ES

1. To evaluate potential safety issues associated with the use of the KeyScope in patients with intra-abdominal cancers or suspected cancers .
2. To determine the clinical performance of the KeyScope in viewing tissue masses in the abdomen.
3. To determine the clinical performance of the KeyLoop in retraction of the abdominal wall during laparoscopic surgery
4. To determine the acceptability of KeySuite laparoscopic devices in aiding to obtain laparoscopic biopsies

Kampala, Mulago II
 Uganda 2025-09-26 17:12:49 2028-09-26 12 The study is targeting 12 adult patients with cancer advised for an intra-abdominal biopsy to be collected for confirmatory. The study will target patients aged between 18 and 60 years. National Institute of Health Engineering and Technology Clinical Trial Non-degree Award
Esther Atukunda Cathyln
ID: UNCST-2019-R001701
 Integration of a patient-centered mobile health intervention (Support-Moms) into routine antenatal care to improve maternal health in Uganda.
REFNo: HS3366ES

Evaluate the cost and cost-effectiveness of implementing Support-Moms intervention into routine care and implications for sustainability,Evaluate intervention implementation using the Proctor framework and plan for future scale-up per the Consolidated Framework for Implementation Research ,Test the effectiveness of the Support-Moms intervention in a randomized controlled trial,
 Uganda 2023-11-13 12:57:49 2026-11-13 824 We will include individuals who: 1) are in the first trimester of pregnancy who have not yet presented for ANC, 2) reside in the catchment area of a study HC, 3) are emancipated minors and adults aged ≥ 18 years, 4) report access to a cell phone with reception in their home, 5) are able to identify at least two social supporters living within the study districts, and 6) are able to provide consent. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
 A phase II/III, open-label, randomized clinical trial to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
REFNo: HS3240ES

To assess the time to insert the REBOA.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy is lower in the intervention arm when excluding ‘inevitable’ hysterectomies due to either an irreparable uterine rupture, a pathological placenta growing into the uterus (placenta accreta, increta or percreta) or a pathological uterus, such as a bicorne uterus or one with very large fibroids.,To assess if post-partum haemoglobin concentration is higher in in the intervention arm compared to the comparator arm,To assess if the number of blood transfusion units is lower in the intervention arm compared to the comparator arm.,To assess if the number of participants with acute kidney injury is lower in the intervention arm compared to the comparator arm,To assess if the proportion of participants with maternal deaths is lower in the intervention arm compared to the comparator arm.,To assess if the proportion of participants with emergency hysterectomy, is lower in the intervention arm compared to the comparator arm., To assess the safety of REBOA in a national referral hospital in a low-income country like Uganda.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy, can be decreased from 50 % in the comparator arm (using standard of care alone) to 30 % or less in the intervention arm (using REBOA). ,
 Kampala, Kawempe
 Uganda 2023-11-13 12:15:41 2026-11-13 10 women in phase IIb and 212 women in Phase III (222 IN TOTAL) Women aged 18 and above years and emancipated minors with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg will be recruited Centre For International Health Medical and Health Sciences Clinical Trial Non-degree Award
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
 Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial
REFNo: HS5151ES

To evaluate the cost-effectiveness of the PPH treatment with HSC compared to PPH treatment with oxytocin, if HSC is proven non-inferior. ,To evaluate the comparative effects of HSC versus oxytocin on haemodynamic outcomes when used for PPH treatment in women receiving HSC for prophylaxis; ,The primary objective of this trial is to evaluate whether HSC is non-inferior to oxytocin for treatment of PPH in women who receive HSC for PPH prophylaxis, in the prevention of additional blood loss of 500 ml or more at 90 min following randomization. ,
 Kampala, Kawempe
 Uganda 2024-11-13 17:36:53 2027-11-13 700 Pregnant women aged 15 years and above UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) Medical and Health Sciences Clinical Trial Non-degree Award
Sarah Lofgren
ID: UNCST-2019-R001647
 Supervised Treadmill intervention to Reduce Inflammation and Depression through Exercise in HIV: The STRIDE Pilot Study
REFNo: HS3358ES

The objective of this study is to determine the feasibility and acceptability of an aerobic intervention via a treadmill among individuals with HIV and depression in Uganda.
3.1 Primary Endpoint: Feasibility and acceptability of Exercise as a treatment for depression in Ugandans with HIV. This will be measured by:
-Percent completion of the prescribed aerobic exercise intervention, as assessed by research staff logging participation.

3.2 Secondary Endpoint(s)/ Outcome(s):
- acceptability of the intervention assessed via a post intervention survey
-feasibility and acceptability of using a wearable exercise tracker to assess the volume of exercise, based on calories burned and steps achieved, during the intervention period among Ugandans with HIV and depression.
- measure the mean and standard deviation of baseline and 8-week serum BDNF and IL-6 level to estimate an effect size and power a future study.
- measure the mean and standard deviation of baseline and 8-week depression score via PHQ-9 to estimate an effect size and power a future study.
- measure the mean and standard deviation in aerobic fitness baseline and at 8 weeks measured via METS/watts achieved and total time/distance to estimate the effect size for a future intervention.
Wakiso, Lweeza
 USA 2024-02-26 13:41:23 2027-02-26 24 • Enrolled in Mildmay HIV clinic • Adults 18-45 years old • HIV positive • Receiving HIV therapy • HIV viral suppression (<400 copies/mL) per chart review • Mild to Moderate (PHQ9 score >5 but >20) • Not currently engaged in a formal exercise program or manual labor such as construction or delivery requiring a manual bike or walking • Able to walk/run on a treadmill • Informed consent University of Minnesota, Makerere University Medical and Health Sciences Clinical Trial Non-degree Award
Joseph Ngonzi
ID: UNCST-2019-R001579
 Automated visual evaluation and geospatial mapping for cervical cancer screening optimization in sub-Saharan Africa (AVE-Map)
REFNo: HS2069ES

3. To use AVE and geospatial analysis to scale up cervical cancer screening in Uganda ,2. To determine access to cervical cancer screening and referral pathways in Uganda ,1. To validate and expand use of AVE for cervical cancer screening in SSA ,We aim to leverage and develop data science expertise at our sites to first optimize and then combine AVE-based screening by health workers at peripheral health facilities with geospatial-analysis and needs-driven assessment to inform scale-up of cervical cancer screening in Uganda ,
 ,
Mbarara, Kakoba
 Uganda 2022-02-28 2025-02-28 2000 Females aged 25 years and above NATIONAL INSTITUTE OF HEALTH Medical and Health Sciences Clinical Trial Non-degree Award
Kamoga Ronald
ID: UNCST-2019-R001524
 VAGUS NERVE STIMULATION IN A RAT MODEL OF ALZHEIMER’S DISEASE-LIKE SYMPTOMS: MORPHOLOGICAL, IMMUNOHISTOCHEMICAL, MOLECULAR AND BEHAVIORAL CHANGES
REFNo: HS3781ES

1. To conduct a scoping review of literature on vagus nerve stimulation in Alzheimer's-disease and related dementias.
2. To determine behavioral changes associated with vagus nerve stimulation in a rat model of Alzheimer-like symptoms.
3. To evaluate the morphological, Immunohistochemical and molecular changes in the Hippocampus, prefrontal cortex and medial temporal cortex associated with chronic stimulation of the vagus nerve in a rat model of Alzheimer’s-like disease.

 Mbarara, Medical cell
 Uganda 2024-02-26 13:43:22 2027-02-26 42 Wistar rats Wistar rats bewteen 3 months and 7 months old Self sponsorship Medical and Health Sciences Clinical Trial 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
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
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
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