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 proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The study will randomize 300 participants people living with HIV , who smoke and who are receiving care in HIV clinics affiliated with the Center for International Health, Education, and Biosecurity in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.
The study will evaluate the safety and acceptability of the topical anesthesia-based, no-flip ShangRing technique vs. Mogen clamp for Early Infant Male Circumcision (EIMC) in neonates and infants up to 60 days of life. The study will consist of 2 phases; a pilot phase and a field study. In the pilot phase, male infants of up to 60 days of life will be enrolled in three sub-Saharan countries, specifically Kenya, Tanzania, and Uganda. Infants will be randomized in 1:1 fashion to undergo EIMC using either the Mogen clamp or no-flip ShangRing technique using topical anesthesia. Upon completion of the pilot trial and assuming satisfactory safety results, a larger non-comparative field study of ShangRing EIMC will be initiated, as performed by non-physician providers in routine practice settings in the three sub-Saharan African countries. Total study duration will be 3 years. The pilot phase is anticipated to encompass a total of 1 year. Completion of the field study is expected to take 2 years. Study Endpoints include: 1. To compare the rates of adverse events (AEs) with the ShangRing or Mogen clamp 2. To compare pain control, time to complete wound healing and parent satisfaction with EIMC using the ShangRing or Mogen clamp 3. To compare operative time and provider preference. 4. To assess the rate of spontaneous ring detachment with the ShangRing as a method to decrease the need for follow-up visits after circumcision. 5. To assess the subpreputial microbiome of the infants prior to and after the initiation of circumcision Three correlative studies will be conducted: 1. Penile microbiome study: In the pilot trial, the subpreputial microbiome of the infants undergoing circumcision will be assessed to better understand the spectrum of bacteria that may exist and play a role in infant circumcision. 2. Demand creation study: During both the pilot phase and the field study, it will be assessed whether device-driven EIMC can be safely and effectively integrated into maternal and child health services as a method to promote demand creation. 3. Cost impact study: During both the pilot phase and the field study, a comparative cost analysis of EIMC with ShangRing versus Mogen clamp will be performed, in addition to a cost analysis of ShangRing EIMC as performed in routine clinical settings in the field study. The costing of demand creation will also be assessed.
The goal of the proposed amplicon sequencing and genotyping study is to assess vaccine efficacy against clinical and asymptomatic malaria infection using ultra-sensitive molecular amplification and sequencing methodology to detect Plasmodium falciparum (P. falciparum) parasites from serial blood samples to be collected from children immunized with the primary and yearly booster immunizations of the RTS,S/AS01E vaccine as part of their participation in Protocol MALARIA-094 (parent clinical study protocol). Genomic analysis will be performed on parasites from blood spot samples collected from children aged 5 17 months immunized with RTS,S/AS01E on different dosage and schedule regimens under the parent clinical study protocol.
The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination. The study also aims to establish the role of third dose spacing in a fractional dose schedule, describe the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple fractional or full yearly doses.
This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.
The BASIC study will take place in Kanduyi/Bungoma South Sub-County, in western Kenya, and focuses on children orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low- and middle-income countries are at higher risk of mental health problems, but mental health professionals are largely unavailable in this area. Research suggests that some mental health treatments can be delivered effectively in low- and middle-income countries using a task-shifting approach, in which lay counselors with little or no prior mental health experience are trained to provide treatment, and deliver with supervision. However, very little is known about how to support local systems and organizations in delivering mental health care via task-shifting, particularly in a way that could scale-able and sustainable in the low-resource context. The BASIC team's prior work suggests that partnering with two government sectors, education and health, could be a low-cost and sustainable strategy to implement task-shifted mental health services. By training teachers (via the Education sector) and community health volunteers (via the Health sector) to provide mental health care, a larger population could potentially be reached. Before attempting any country or system-wide implementation, it is important to know what is needed to enable successful implementation in either or both sectors, client outcomes for those receiving mental health care when delivered via Education or Health, and cost of delivery in both sectors. The team aims to collect outcomes that are relevant to policy makers, and that can be considered along with cost and experiences in both sectors.
The purpose of this study is to conduct formative research to inform the design and implementation of combination prevention interventions, including pre-exposure prophylaxis (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention strategies for female sex workers and their male clients in Kenya.
Background: In children and adults living with HIV, cardiomyopathy is a major source of comorbidity. Traditional echocardiographic measures are insensitive and consequently cardiomyopathy often goes undiagnosed until late stages of disease. Myocardial deformation imaging represents a promising means to identify early dysfunction, but to date there have been no large studies using strain or strain rate to assess cardiac function in children with HIV and to establish predictors of worse cardiac function such as viral burden and ART regimen. These studies are critically important as earlier diagnosis and intervention represent the best means to alter the course of HIV-associated cardiomyopathy. Objectives: To determine the association of biomarker levels, myocardial deformation, and viral load level history in HIV infected children attending Moi Teaching and Referral Hospital (MTRH) clinic. Design: A cross-sectional study on clients attending HIV clinic, MTRH. Setting: Module 4 HIV clinic at MTRH in western Kenya, Africa. Population: HIV-infected children attending clinic in 2017 - 2018 Main Measures: Echocardiographic function assessment, Age, Immune status, other illnesses, ART status. Conclusions: The study will explore the NIH/HIV High Priority Target area of HIV-associated cardiac co-morbidities and will enhance understanding of the relationship between cardiac function and viremia. The investigators expect to be able to reliably define a subset of children with worse cardiac function by risk factors: specific ART regimens, less time virally suppressed, and increased BNP biomarker.
The specific aim of this pilot study is to estimate the impact of a new digital health service on the uptake of family planning among Kenyan women with an unmet need for contraception. Enrolled women will be randomized to a control arm or an encouragement arm that will receive a special invitation to try the new service.
A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.