There are about 849 clinical studies being (or have been) conducted in Uganda. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study involves efforts to advance the science of prevention in early childhood mental health in low-resource communities. Investigators will assess the effectiveness, practical implementation strategies, and underlying mechanisms of the evidence-based intervention, ParentCorps-Professional Development, in urban and rural Uganda. Two implementation approaches, with and without the teacher stress management package, T-Wellness, will be compared for efficacy.
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection.
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly reduce the risk of adverse birth outcomes compared to IPTp with SP alone or DP alone. This double-blinded randomized controlled phase III trial of 2757 HIV uninfected pregnant women enrolled at 12-20 weeks gestation will be randomized in equal proportions to one of three IPTp treatment arms: 1) SP given every 4 weeks, or 2) DP given every 4 weeks, or 3) SP+DP given every 4 weeks. SP or DP placebos will be used to ensure adequate blinding is achieved in the study and follow-up will end 28 days after giving birth.
Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 13 times higher than other adults aged 15-49 years. In Uganda, HIV prevalence among TGW is 22% compared to 5.9% in the general population. Encouraging use of self-controlled HIV prevention tools - specifically, HIV self-testing (HIVST), STI self-sampling (STISS) and antiretroviral pre-exposure prophylaxis (PrEP) - to those testing HIV negative could decrease HIV incidence among African TGW. This R34 application proposes formative research and a pilot trial to develop an HIV prevention intervention for African transgender women (TGW). The investigators will evaluate whether peer-delivered combination HIV prevention increases testing uptake and empowers effective prevention decision making in TGW. Peer-led interventions are effective in increasing HIV and STI testing among other hard-to-reach vulnerable populations with high HIV prevalence but low testing coverage and are recommended by the World Health Organization. Exploring peer-delivery approaches to increase coverage of combination HIV prevention interventions is key to addressing research gaps in HIV epidemic control. However, little is known about the effectiveness of peer-delivered combination HIV prevention (HIVST, STISS and PrEP) for African TGW, or the best way to deliver care to this population. Key knowledge gaps include: 1) whether peer delivery increases testing rates and status knowledge, 2) the role of peers in creating demand for repeat testing and PrEP, and 3) how to optimize peer delivery of combination HIV prevention (HIVST, STISS and PrEP). To address these questions, this proposal seeks to conduct formative research to inform implementation of peer-delivered combination HIV prevention for African TGW (Aim 1), implement a pilot cluster randomized trial to evaluate the feasibility, acceptability and preliminary effectiveness of peer delivered combination HIV prevention (Aim 2), and conduct in-depth interviews to explore how peer-delivery of HIVST, STISS and PrEP influences prevention choices among TGW and sexual partners (Aim 3). This will be the first clinical trial, to our knowledge, to evaluate HIV self-testing and STI self-sampling in HIV-uninfected TGW. Pilot data from TGW and their partners will provide unique perspectives to inform HIV prevention delivery. The proposed proof-of-concept evaluation is uniquely positioned to improve prevention uptake for African TGW - a high-risk, marginalized, and underserved population. Rigorous application of mixed methodologies will generate actionable data for policy and programs, and provide a strong foundation for scalable implementation of cutting edge combination HIV prevention interventions for African TGW. The local transgender community is involved in study design, planning and implementation. This project is supported by the Ugandan Ministry of Health.
Hypothesis: Infections other than HIV can cause LN inflammation and collagen damage to the fibroblastic reticular cell network (FRCn), which will lead to CD4 T cell depletion and impaired vaccine responses. This protocol will study yellow fever vaccine (YFV) in two cohorts of people, one from Uganda and the other from Minnesota where we collect lymphoid tissues (LT) and peripheral blood monocytes (PBMCs) before and after vaccination using a new technique to catalog infectious burden of the individual, determine the relationship between IA, Infections, and immune response.
The objectives of this data collection activity are to: 1. Describe the baseline demographics, clinical and laboratory profile of patients who ever received darunavir (DRV) and/or etravirine (ETR), at the time of initiation on DRV and/or ETR; 2. Describe the clinical and laboratory profile of patients who ever received DRV and/or ETR every 6 months from the first data collection point through 2021; 3. Describe dynamics in HIV drug resistance mutations among patients who fail treatment on new regimens including DRV and/or ETR; 4. Describe demographics, clinical and laboratory profile of young adults who transition out of the donation program after the age of 25 years at 12 months after their transition.
The purpose of this study is to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination.
This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The hypothesis is that the two antibodies will be safe for healthy HIV-1 uninfected adults when co-administered subcutaneously or intravenously and, after subcutaneous administration in the optimal ratio, each antibody will maintain serum levels >10 µg/ml for at least 3 months in HIV-uninfected participants.
This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.
The standard treatment for TB consists of rifampicin (RIF) as part of the regimen. However, due to drug-drug interactions (DDI), the bioavailability of PIs is greatly reduced when co-administered with RIF necessitating use of higher doses of the PI to overcome this effect. However, the potential effect of this increased dose on the DDI with bPIs is uncertain. Though some data has been collected that shows safe use of higher doses of LPV to overcome the DDI with standard doses of RIF in HIV-infected individuals, no substantive data has been collected on ATV to correctly adjust its dose when co-administered with RIF-based TB treatment. Physiologically-based pharmacokinetic (PBPK) modelling was developed to understand ATV and RIF DDIs, and identified potential dosing strategies to overcome this challenge in adults and special populations under workpackage 1 of the VirTUAL consortium. From this work, it is anticipated that the dose of ATV/r should be increased from 300/100 once daily to 300/100mg twice daily in order to overcome the interaction with rifampicin and attain therapeutic plasma concentrations. This dose escalation trial aims to: 1. Evaluate the steady state plasma and intracellular PK of ATV/r, when administered in adjusted (PBPK model-predicted) doses concurrently with RIF 2. Evaluate the safety and tolerability / acceptability of the adjusted dose of ATV/r that provides the therapeutic concentration when co-administered with RIF. 3. Evaluate the concentration of dolutegravir (DTG) and RIF when co-administered and explore the potential DDI with ATV/r