There are about 746 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 study seeks to assess the safety and define blood and tissue benchmark concentrations of Tenofovir (TFV) and Tenofovir diphosphate (TFV-DP) in Cisgender women using directly observed tenofovir alafenamide (TAF)-emtricitabine (TAF-FTC) pre-exposure prophylaxis (PrEP). These data will help accurate interpretation of efficacy results obtained in HIV prevention trials and programs in cisgender women.
The objective of the MoreMilk trial is to assess the effect of a Training, Certification and Marketing intervention for milk vendors in the informal sector on the safety of the milk sold in the markets and on the nutrition of children in peri-urban areas of Kenya. The intervention is a training scheme for dairy vendors designed to improve the vendors' business skills and increase their capacity to handle milk hygienically and recognize good quality milk. It will also support vendors to adopt marketing strategies and pass on messages to their customers on the role of milk for nutrition and good food handling practices. The intervention consists of a 12hr face-to-face training, followed by quarterly visits where milk safety is tested and results are reported back to the participants. To assess the effect of this intervention on milk safety, and selected health and nutrition outcomes, the study will work with two groups of participants: dairy retailers, referred to as dairy vendors, operating in the informal sector and consumer households that purchase milk from recruited vendors. Dairy vendors will be randomly allocated to receiving the training at the beginning of the study (treatment group) or at the end of the study (control group). A baseline survey will be administered to participating vendors and households, and an endline survey will be conducted 12 months after baseline in the same vendors and households. The vendor baseline and endline surveys will include questionnaire modules on operations, milk handling practices, and business performance. A sample of milk will also be collected to test the microbiological quality and composition of the milk. Vendors will be visited 2 additional times during the 12 months between intervention and endline, to monitor practices and business performance and to collect a milk sample to be tested for microbiological quality and milk composition. The baseline and endline surveys in households will assess milk and food expenditure, milk handling and consumption practices, and a 24hr dietary recall for the index child.
The investigators will conduct a cluster randomized controlled trial in maternity facilities in Kenya to evaluate the impact of a maternal and neonatal health package intervention on patient and provider outcomes. This package intervention includes two programs: PROMPTS, a digital health platform for mothers aimed to improve knowledge and health behaviors and increase care-seeking behavior at the right time and place, and MENTORS, a facility-based program aimed to increase and sustain providers' knowledge and skills in basic and emergency obstetric and newborn care. Facilities will be randomized into a treatment group that receives the package or a control group that receives usual care. Patient outcomes include health knowledge, health behaviors and health care utilization in the prenatal and postnatal period; provider outcomes include knowledge and quality of care.
This is a randomized, double-blind, placebo-controlled study in sickle cell disease participants with a history of Vaso-occlusive Crises (VOCs). Approximately 60 participants with sickle cell disease will be enrolled and randomized: 12 participants in each of four active novel formulation rifaximin groups and 6 participants in each of 2 placebo groups.
By introducing pulse oximetry, with or without clinical decision support algorithms, to primary care facilities in India, Kenya, Senegal and Tanzania, the Tools for Integrated Management of Childhood Illness (TIMCI) project aims to contribute to reducing morbidity and mortality for sick children under-five while supporting the rational and efficient use of diagnostics and medicines by healthcare providers. The multi-country, multi-method evaluation aims to generate evidence on the health and quality of care impact, operational priorities, cost and cost-effectiveness of introducing these tools to facilitate national and international decision-making on scale-up.
This is an open label study to evaluate the safety and immune response to a booster dose of Ad26.ZEBOV Ebola vaccine in HIV+ adults from Kenya and Uganda. Only participants who have received the 2-dose Ebola vaccine regimen "Ad26.ZEBOV/MVA-BN-Filo " in the VAC52150EBL2002 vaccine trial about 4 years ago are eligible to take part. Approximately 50 healthy HIV+ adults, aged 18 - 50 years at the time of the parent trial, will be invited. Participants will first be asked to provide consent to participate in this study. Upon receiving the booster vaccination, participants will be followed up for approximately 28 days (+/- 3 days) to collect information on side effects and provide blood samples for antibody measurement. This study is designed to provide descriptive information regarding vaccine safety and immunogenicity. There is no formal treatment comparisons and no formal testing of statistical hypothesis.
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) design an intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels.
The objective of this study is to evaluate the efficacy of a diet-related mHealth (mobile health) intervention on glycated hemoglobin among adults with type 2 diabetes. The study hypothesizes that using mHealth influences food literacy and dietary behavior and may result in a reduction of glycated haemoglobin (HbA1c) by at least 0. 3% in 12 weeks in adults with type 2 diabetes. This study will be conducted in Nakuru County, a cosmopolitan county located in Northwestern Kenya. Participants will be eligible to be included in the study if they will meet the following criteria: (i) adults over the age of 18 years; (ii) diagnosed with type 2 diabetes in the previous 1 year and obtaining care at a participating level 4 hospital; (iii) able to read and write English or Swahili Language; (iv) currently own and able to read and send mobile text messages using any phone. Participants will be excluded if they are on dialysis or pregnant. The primary outcome measure will be HbA1c, which shall be measured at baseline and at the end of the intervention. Secondary outcome measures will include fasting plasma Glucose (FPG), total cholesterol (TC), triglycerides (TG) and high-density lipoprotein-cholesterol (HDL-C). Other secondary outcome measures will include anthropometric measurements (weight, height, waist and hip circumferences) and behaviour change (changes in dietary intake of legumes, fruits and vegetables). Additionally, mHealth satisfaction shall be assessed at 12 weeks and 24 weeks post-intervention to assess the sustainability of the intervention.
Youth living with HIV in Kenya frequently use substances and this negatively affects their mental health as well as viral suppression. The goal of this study is to evaluate the feasibility and acceptability of a peer-delivered substance use screening and brief intervention for these youth.
The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.