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 Pocket colposcope has 510k FDA clearance and has been successfully used in ~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at 4-6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.
Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.
OBJECTIVE: To assess the efficacy and safety of switch to dolutegravir and lamivudine (DTG/3TC) single tablet regimen from bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in persons living with HIV aged 60 years old or more. METHODS: This is a phase 3b, multi-center, open-label, single-arm clinical trial over 96 weeks. The study will take place at two sites in Kenya: Kenyatta National Hospital (KNH) and Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Study visits will take place at screening, baseline, and weeks 4, 12, 24, 36, 48, 60, 72, 84, and 96 (with a 6-week extension as required for confirming HIV-1 RNA levels). A target of 240 participants from the ongoing B/F/TAF Elderly Switch Study will be enrolled. Eligible participants will be switched from B/F/TAF to DTG/3TC at enrollment and followed up for 96 weeks. The primary endpoint will be the proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at Week 48. Analysis of the primary endpoint will be performed for the intention to treat - exposed (ITT-E) population using the FDA snapshot method.
The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili). The intervention, delivered by lay counselors and through existing community social structures, is expected to improve family functioning and individual mental health among members. The sample includes families with a child or adolescent (ages 8-17) experiencing problems in family functioning.
This study will test a new drug (MAM01) to find which doses are safe and could help prevent people from getting malaria. The study will take place in parts of Africa where malaria is common. Parts A and B of the study will first test single doses of MAM01 in healthy adults, then after safety review, in older children, and then after additional safety review, in infants. Part C will then test single doses of MAM01 in children and infants who have a medical problem that could put them at greater risk if they get malaria.
This study seeks to respond to the growing burden of adolescent mental health disorders and urgent preventive service needs in Kenya by studying the effectiveness of a digital health intervention- mobile health (mHealth) Toolkit for Screening & Empowering Lives of Youth (mSELY)-that has demonstrated feasibility from our prior pilot study. The investigators will build on this work and examine two versions of mSELY. The mSELY-A is designed for adolescents to self-evaluate and manage psychological wellbeing/mental health needs, as well as to gain resources and access and connect with adolescent peers. The mSELY-P is designed for parents to self-evaluate their adolescent's development and mental health, gain awareness about their adolescent's mental health status, and learn strategies and resources to support adolescents' mental health. Both versions provide screening, tailored mental health literacy materials, and decision support for adolescents and/or their parents. This study will examine the effectiveness of these digital interventions using a randomized control trial with diverse community-based organizations in Kenya. In addition, the investigators will study underlying mechanisms that contribute to intervention effectiveness, as well as to use the data for precision medicine analysis (using machine learning approach). Findings will be used to improve Digital-Toolkit decision support functions and accuracy of mental health precision care.
The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources. The main questions it aims to answer are: - What are the fetal heart rate monitoring practices in a low-resource setting? - What are the indications for operative delivery in a low-resource? - What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil? - What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting? Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected. Participants will: - Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor - Have the (mothers & babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag & mask ventilation, Apgar scores, and seizures. - Have a neonatal neurological assessment prior to discharge - Have phone call assessments for re-hospitalization or mortality 7 days post-delivery - Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia.
The goal of this clinical trial is to implement and examine the impact of SafeCare Kenya, an adapted parenting program, to improve parents' skills and knowledge related to the care of their children between the ages of 18 months and 5 years old. The main questions it aims to answer are: - Will SafeCare Kenya improve child and parent outcomes? - Is virtual delivery as effective as in-person delivery of SafeCare Kenya? - Is SafeCare Kenya feasible to deliver by community health volunteers? Mothers will: - Complete study assessments at three timepoints: baseline, 6 months and 18 months - Mothers in the SafeCare Kenya group will receive the program from their community health volunteer Researchers will compare SafeCare Kenya to care as usual by community health volunteers to see if SafeCare Kenya families show improvements in parent interaction skills, safety and health knowledge, potential for child abuse, child behavior problems, child injuries, parenting stress, and child and parent quality of life.
This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention and comparison communities, schools, and health facilities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators.
The goal of this interventional study is to evaluate the impacts of Financial Inclusion improvement sanitation and Health (FINISH) interventions in Kenya's Homa Bay County and Uganda's Kamwenge District among children under five. The main questions it aims to answer are: 1. What is the estimated impact of the FINISH model on health outcomes (diarrhoea occurrence and hygienic behaviour) as well as social (school attendance and sanitation) in the intervention groups? 2. What are the perspectives, attitudes, and practices of various stakeholders (communities, governments, entrepreneurs, and financiers) regarding the FINISH model? 3. What is the cost-effectiveness of the FINISH model, including the amount of leverage funds generated? The FINISH model postulates that countries will be supported to improve the enabling business environment for sanitation, markets to offer improved safely managed services and products at an affordable price, and formal and informal financial institutions will offer more funding to businesses and households for satiation and hygiene. Researchers will then compare intervention areas (Homa Bay in Kenya and Kamwenge in Uganda) with control areas (Siaya and Bushenyi in Kenya and Uganda, respectively) to see if the FINISH intervention leads to improved sanitation, health outcomes, and economic benefits.