Approved Research This page provides a searchable list of all research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology(UNCST).
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Name Title Nationality Approval Date Expiry Date Field of Science/Classification Trial Type Research Type  
Samuel Kawuma
ID:
Facilitators and barriers to retention on Pre-exposure prophylaxis (PrEP) among Female Sex Workers attending Kiruddu National Referral Hospital.
REFNo: HS2771ES

1. To identify the implementation gaps along the Pre-Exposure Prophylaxis continuum of care and assess the factors associated factors with retention on PrEP among FSWs at Kiruddu National referral Hospital.,To design a stakeholder informed evidence-based intervention to improve retention on PrEP among FSWs at Kiruddu National Referral Hospital ,2. To determine the facilitators and barriers of retention on PrEP among FSWs in care at Kiruddu National referral Hospital.,
Uganda 2023-04-12 14:43:04 2026-04-12 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Francis Ssali
ID: UNCST-2021-R012134
Protocol A5394: “Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV” Version 1.0, May 27, 2022
REFNo: HS2647ES

1.2 Primary Objectives

1.2.1 To assess the safety and tolerability of treatment with SLGN administered once weekly by mouth for 24 weeks.

1.2.2 To determine the proportion of participants with ?1 log10 IU/mL decline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24.

1.3 Secondary Objectives

1.3.1 To determine the proportion of participants with ?1 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.2 To determine the proportion of participants with ?0.5 log10 IU/mL decline in qHBsAg after SLGN treatment at Week 24.

1.3.3 To determine the proportion of participants with ?0.5 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.4 To evaluate the proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up.

1.3.5 To evaluate changes in qHBsAg levels at Weeks 4, 12, 24, 36, and 48 after SLGN initiation and, separately, among the placebo recipients.

1.3.6 To determine the proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study, by study arm.

1.3.7 To determine the proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study, by study arm.

1.3.8 To determine the proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study, by study arm.
1.3.9 To evaluate levels of circulating cytokines, including IFN-gamma, IL-12p40, IL-1RA, and CD163 at entry, 24 hours post-first study drug dose, Weeks 4, 12, 24, 36, and 48, by study arm.

1.3.10 To determine whether administration of SLGN will perturb HIV latency as measured by an increase in HIV transcription.

1.3.11 To determine whether administration of SLGN will decrease the size of the latent reservoir, as measured by the change in amount of cell-associated unspliced HIV RNA, HIV DNA, replication-competent and/or intact virus at Weeks 2, 4, 24, and 48.

1.4 Exploratory Objectives

1.4.1 To define the pharmacokinetic (PK) profile and PK-pharmacodynamic (PD) associations of SLGN in people with both HIV and CHB taking suppressive antiviral therapy for both viruses.

1.4.2 To explore if SLGN and antiretroviral (ARV) PK are altered when administered together.

1.4.3 To evaluate participants’ adherence by using several tools, including self-report, directly observed therapy (DOT), and drug concentrations.

1.4.4 To compare quantitative changes in experimental measures of HBV antiviral efficacy (including HBV RNA, hepatitis B core related antigen [HBcrAg], qHBeAg, and low positive HBsAg measured with a high sensitivity qHBsAg assay [LLOQ of 0.05 IU/mL]) and measure changes in large, medium, and small HBsAg isoforms from baseline during and after treatment.

1.4.5 To determine the immunological effects of SLGN on circulating immune signaling by performing single cell RNA sequencing using peripheral blood mononuclear cells (PBMCs) and evaluating HIV-specific T-cell responses.

1.4.6 To determine the effects on circulating immune cells, including cellular phenotypes and T and B-cell responses.

1.4.7 To determine whether administration of SLGN will affect levels of circulating cytokines, including TNF-alpha, IL-12, IL18, IP-10, ISG15, IL-21, Fas Ligand, and TRAIL.

Uganda 2023-04-12 14:38:49 2026-04-12 Medical and Health Sciences Clinical Trial Non-degree Award
Alex Mwesigwa
ID:
P. falciparum genetic diversity, multiplicity of infection, gametocytaemia and recrudescence in areas of varied malaria transmission intensity in Uganda.
REFNo: HS2744ES

1. To compare the genetic diversity and multiplicity of P. falciparum infections in areas of varied malaria transmission intensity in Uganda.
2. To evaluate the relationship between malaria severity and P. falciparum genetic diversity, multiplicity of infection among patients living in areas of varied malaria transmission intensity in Uganda.
3. To investigate the temporal and seasonality changes in P. falciparum genetic diversity and multiplicity of infection among patients with malaria infection living in areas of varied malaria transmission intensity in Uganda.
4. To evaluate the performance of microsatellites in differentiating P. falciparum recrudescence from new infections.

Uganda 2023-04-12 14:27:32 2026-04-12 Medical and Health Sciences Non-Clinical Trial Degree Award
Jane Frances Zalwango
ID:
Etiopathogenesis of Blackwater Fever in Budaka District, Uganda: a pilot study
REFNo: HS2752ES

a)To explore the aetiology of BWF in Budaka District b)To identify therapeutic interventions for the treatment of BWF
Uganda 2023-04-12 14:23:40 2026-04-12 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Elizeus Rutebemberwa
ID: UNCST-2022-R009070
Evaluation of a Community Health Entrepreneur model in rural Uganda
REFNo: HS2196ES

4.3 General objective
To explore the role, reach, and scalability of CHE programme as a social franchise approach to address the issue of access to healthcare and potential embedment of the programme in the larger health system.

4.4 Specific objectives
1. To investigate health care seeking behaviour of residents in rural communities in Uganda, in order to assess community access, choice and use of health (care) services, service availability and quality, and experience of health care of households in villages in Uganda
2. To investigate the strengths and weaknesses of a CHE programme in communities which already have adopted this programme and the potential added value of a strengthened community health system by a CHE programme in communities without this programme
3. To investigate multi-stakeholder perceptions on the functioning, potential scale-up, and the possibility of integration of a social franchise approach in the larger health system in Uganda


Uganda 2023-04-12 14:20:54 2026-04-12 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
Protocol for the establishment of clinical specimen panel for WHO Prequalification performance evaluation of HIV serology assays
REFNo: HS2786ES

To establish an HIV specimen repository at ITM.,To register the specimens into a Biobank at ITM; ,To characterize the specimens for HIV and syphilis serostatus using standardized reference assays and algorithms at ITM;,To collect biological specimens from patients with known HIV serostatus or blood donors from different regions of the world to establish a WHO HIV specimen evaluation panel that will be used for the laboratory performance evaluation of HIV serology assays undergoing WHO prequalification assessment; ,The overall objective is to assemble a new WHO HIV specimen evaluation panel in collaboration with PELs and collaborating centers, which will be made accessible on demand to all the PELs conducting HIV or dual HIV-syphilis serology test evaluations for WHO prequalification.,
Uganda 2023-04-12 12:56:08 2026-04-12 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Edgar Mulogo Mugema
ID: UNCST-2023-R008170
Environmental Drivers of Pediatric Postinfectious Hydrocephalus in Western Uganda: Case-Control Study
REFNo: HS2699ES

The overarching objective of the study is to elucidate potential factors that underlie the ecological correlation between precipitation and PIH. Identification of these environmental intermediaries may elucidate potential targets for intervention to reduce the incidence of PIH.,
Uganda 2023-04-11 15:42:30 2026-04-11 Medical and Health Sciences Non-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.
Uganda 2023-04-11 15:27:11 2026-04-11 Medical and Health Sciences Clinical Trial Non-degree Award
Andrew Muhumuza
ID: UNCST-2022-R009010
Incidence and predictors of castration resistance among patients with prostate cancer on androgen deprivation therapy at two referral hospitals in Uganda
REFNo: HS2759ES

To identify the predictors of castration resistance among prostate cancer patients on ADT at Mbarara Referral Hospital oncology unit and Uganda cancer Institute, Mulago National Referral Hospital. ,To determine the incidence of castration resistance among patients with prostate cancer on ADT at Mbarara Referral Hospital oncology unit and Uganda cancer Institute, Mulago National Referral Hospital.,To determine the incidence and predictors of castration resistance among prostate cancer patients on ADT at Mbarara Referral Hospital oncology unit and Uganda cancer Institute, Mulago National Referral Hospital.,
Uganda 2023-04-11 14:20:29 2026-04-11 Medical and Health Sciences Non-Clinical Trial Degree Award
SAM ALI
ID: UNCST-2020-R014824
Stillbirth in High Burden Settings: Ample Room for Improvement using Biomarkers and Ultrasound Technologies (iTECH)
REFNo: HS2762ES

1. To evaluate the relation between placental histopathological lesions and biomarkers, placenta ultrasound and hemodynamic changes after stillbirth and near miss stillbirth in order to understand the underlying mechanisms and specify the prediction model. 2. To engage with important stakeholders on the value of these diagnostic technologies in the community, co-creating the project design, implementation and eventual uptake into practice guidelines. 3. To establish the predictive performance of maternal characteristics and markers emerging from this project for stillbirth and other related endpoints in non-anomalous fetuses and assess the feasibility of integrating relevant markers into clinical decision support tools. 4. To prospectively evaluate patterns of (bio)markers, maternal cardiovascular function and contemporary ultrasound markers in pregnancy, to understand their role in the chain of events and pathophysiology of stillbirth in a resource poor setting. 5. To develop and validate a prediction model for use at the point of care in low-and middle-incomes countries (LMICs) to quantify a woman’s individual risk of antepartum stillbirth based on a set of easily measurable, accessible, highly predictive and cost-effective markers, and make it freely available for healthcare providers in low-resource settings.
Uganda 2023-04-06 8:06:27 2026-04-06 Medical and Health Sciences Non-Clinical Trial Non-degree Award
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