There are about 751 clinical studies being (or have been) conducted in Kenya. 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.
The primary objective of this study is to compare the effectiveness of classroom-based behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of care intervention, on reducing the incidence of self-reported sexual assault among girls from baseline. Secondary objectives of this study is to determine the impact of the interventions on related physical and mental health status/outcomes, STI-risk behaviors, self-efficacy, and self-esteem.
Knowledge of HIV status is a first step towards accessing HIV care, treatment, and prevention services.The GIRLS study will rigorously compare two 'seek' recruitment strategies, three 'test' strategies, and two enhancements to an adaptive (SMART trial design) 'linkage' to care intervention, among young at-risk women, 15-24 years old, in Homa Bay County, western Kenya. Additionally, we will evaluate a scalable primary prevention messaging intervention to support identified HIV-negative young women in reducing HIV risk and adhering to recommended HIV re-testing recommendations. We will also conduct an economic evaluation, using cost effectiveness analyses to determine the relative utility of each seek, test, link, and prevention interventions. Lessons learned will inform Government of Kenya, and other key policymakers, implementing partners and agencies throughout sub-Saharan Africa that are exploring policies about appropriate scale up of these multiple seek, test, link, retain, and prevention strategies to realize the dream of an AIDS-free future for adolescent girls and young women.
The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant women before, during and after delivery and evaluate the HITSystem impact on prevention of mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0 intervention will support a range of PMTCT outcomes including retention in care, ART adherence, and integration of maternal and pediatric HIV services in low-resource settings.
The study will evaluate interventions to improve engagement in HIV care following HIV diagnosis through a voluntary counseling and testing program. The specific aims are to (1) determine if a VCT-based intervention of CD4 count testing, alone or in combination with peer counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the intervention on ART initiation. The study will recruit 450 HIV-positive individuals from VCTs and randomize a third to standard counseling and referral, a third to receive CD4 testing at the VCT with results return by phone after 1 weeks, and a third to receive the same CD4 testing combined with peer counseling. These combined investigations will create a comprehensive understanding of obstacles to appropriate HIV/AIDS care and result in new interventions to achieve measurable outcomes in applied settings.
This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy children aged 5 months through 9 years of age living within approximately 10 km of the study clinic(s) (Siaya County Referral Hospital, or Wagai dispensary, a government health facility in Wagai division) will be eligible for participation in Part 1; healthy infants aged 5 months - 12 months inclusive will be eligible for Part 2.
The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.
This study evaluates the efficacy and safety of 3 months of malaria chemoprevention post-discharge using dihydroartemisinin piperaquine (DHA-P) in children under 5 years of age admitted with severe anemia. One half will receive monthly DHA-P and the other half placebo.
Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA. However, in areas with a high burden of infectious diseases iron may increase the risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus, there is an urgent need to find safer formulations of iron fortification for African infants. The investigators recently finished a randomized, double blind controlled intervention trial in Kenya where the investigators tested whether the addition of galacto-oligosaccharides (GOS) in a MNP containing 5 mg of iron protects against the adverse effects of the iron on the infant gut microbiome and gut inflammation (ClincalTrails.gov Identifier: NCT02118402). Prebiotics are also potential enhancers of colonic iron absorption. Therefore, to complement the intervention study, the present study will compare iron absorption from the combination of sodium iron EDTA (NaFeEDTA) and ferrous fumarate (FeFum) with and without prior consumption GOS or 3 weeks. The investigators will enroll 80 Kenyan infants from Kwale County, aged 6-14 months of whom 40 infants will consume maize porridge blended with MNP containing iron and 40 infants will receive a porridge mixed with MNP containing iron+GOS. After 3 weeks of MNP consumption, two test meals will be fed on two consecutive mornings, and will consist of maize porridge containing isotopically labeled FeFum and NaFeEDTA or isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen days after the second test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. A stool sample will be collected at baseline and on the first test meal day. The gut microbiome, fecal pH and fecal SCFAs profile will be analyzed. Knowing the expected iron absorption from the iron and GOS containing MNP will inform decisions on type of iron compound and dosing regimens for MNPs to allow the lowest iron dose to be used but still cover the infant requirement for absorbed iron.
The purpose of this study was to evaluate the pharmacokinetics (PK), tolerability, and safety of once-weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and HIV-1-uninfected pregnant and postpartum women with latent tuberculosis (TB).
The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive SMS intervention to optimize individual health and secondary HIV prevention benefits of ART in HIV-positive FSWs.