There are about 744 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.
Diarrhea remains a leading cause of death among young children, with the majority of diarrhea deaths occurring in low- and middle-income countries. Childhood diarrhea caused by a type of bacteria called "Shigella" is responsible for an estimated 60,000 deaths each year and may cause particularly severe illness among children. Currently, there are several promising vaccines to prevent Shigella diarrhea in development, but key information is still needed to inform future vaccine studies. The purpose of this study, titled Enterics for Global Health (or the "EFGH"), is to determine the number and rate of new cases of Shigella diarrhea among children 6 to 35 months of age presenting to health facilities with diarrhea or dysentery. Over a two-year period, the EFGH study will enroll 1,400 children from each of the seven countries: Peru, Pakistan, Bangladesh, Mali, Malawi, Kenya, and The Gambia (9,800 children total).
This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, Kenya, South Africa, and Zimbabwe. The study will assess the acceptability and safety of two placebo vaginal films. The placebo films do not contain any active medication, are the same size, but differ by shape (square versus rounded corners). Participants will be randomly assigned to one of the two films and asked to use (self-insert) the assigned film two times (approximately one month apart). Participants will be asked to refrain from sexual activity during the first month of use and may resume usual sexual activity during the second month of use. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples. The study involves a total of 10 visits/contacts, including in person visits and telephone calls over approximately 9 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in depth interviews to further assess acceptability, attitudes, and experiences with film use to gauge interest in the future use of vaginal films as a HIV prevention option.
The goal of this pilot study is to evaluate the feasibility, appropriateness, and acceptability of a mental health prevention intervention among adolescents during pregnancy and the year after birth (perinatal period) in Kenya and Mozambique. The main questions it aims to answer are: - Is the intervention feasible, acceptable, appropriate, and delivered/received with high fidelity, to adolescent girls, their friends/family members and service providers? - Are the implementation strategies acceptable, appropriate, feasible to all relevant stakeholders? - What impact does the intervention have on adolescent mothers' mental health? - What impact does the intervention have on adolescent mothers' social, economic, and education outcomes? Participants will: - Participate in nine individual and group sessions focused on improving mental and perinatal health literacy and increasing life skills - Receive standard perinatal care Researchers will compare findings with girls receiving standard perinatal care only to see if the intervention has an impact on adolescents' mental health, social, economic and education outcomes.
A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
This study will evaluate the effect of a brief alcohol counseling intervention on PrEP and PEP adherence among adults with heavy alcohol use at high risk for HIV, while gaining insights into the facilitators, barriers, and cost-effectiveness of this approach.
Malnutrition in all its forms is still a problem in resource limited settings including Kenya driven by low diet quality, food preparation and feeding practices including hygiene. Edible insects are currently of interest in alleviating malnutrition due to their energy density, high protein, vitamins and micronutrients (iron, zinc). Among the insects of preference are the crickets which have been shown to encourage the growth of probiotics (Bifidobacterium animalis) which support gut health increasing nutrient absorption and reduces systemic inflammation. Despite the nutritional value of insects and the contribution of cricket to improved gut health, there is limited evidence on the benefit of cricket based complementary food in the reduction of stunting amongst infants and young children. This study aim to determine the effect of integrating two nutrition interventions (cricket enriched porridge with nutrition education) on the infant and young child growth (stunting) and gut health in Alego Usonga Sub-County in Siaya County of rural western part of Kenya.
Global Alliance for Improved Nutrition (GAIN)'s "Vegetables for All" program in Kenya seeks to improve consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different vegetables by operating at multiple levels - individuals, households, markets, producers, and policies. RTI and local partners propose to conduct impact and process evaluations of GAIN's program tailored to the theory of change. The evaluation will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) evaluation framework.
This study will evaluate the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and adolescents. The study will also assess the duration of protection provided by different doses of M5717 plus pyronaridine and the additional contribution of M5717 to the duration of protection using external study data.
Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common. The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya. In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.
Although African traditional fermented foods have been linked to health benefits, research pertaining to the use of uniform products in the control of blood glucose is lacking. This study is aimed at assessing the effectiveness of African traditional fermented foods at reducing blood sugar amongst adult pre-diabetic patients. This study shall comprise a multi-centre parallel (3-arm) randomized controlled trial of a fermented milk product, a fermented cereal-based product, and standard medical care. 252 pre-diabetic adults shall be recruited from 12 treatment facilities located at 4 Counties (3 clinics from each County) across Kenya. The primary outcome is change in glycated haemoglobin. Secondary outcomes shall include, change in weight (BMI), waist circumference, levels of fasting plasma glucose, C reactive protein and lipid profile. Safety as well as the acceptability and experience of fermented foods as a treatment modality for pre-diabetes will additionally be assessed amongst study participants. At each study site, data comprising clinical measurements and responses from self-report questionnaires shall be collected over a follow-up period of 12 weeks. Two focus group discussions shall additionally be held in week 13. Comparison of the mean changes between the three groups shall be carried out using Analysis of Variance (ANOVA). Pairwise comparisons shall additionally be undertaken using linear mixed regression models.