Kisumu

Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Researchers are evaluating the long-term safety and effectiveness of etavopivat, a new oral medicine being developed to treat inherited blood disorders such as sickle cell disease and thalassemia. These disorders affect hemoglobin, the protein responsible for carrying oxygen in the body. This phase 3 study aims to monitor how well etavopivat works and its safety profile over an extended period. Participants will receive one of three forms of etavopivat (A, B, or C) as oral doses. The study is open-label and multicenter, involving adults, adolescents, and children who have previously completed treatment in an etavopivat parent study and continue to benefit clinically. The treatment period can last up to 264 weeks but may end earlier if etavopivat is approved in the participant's country. During the study, researchers will track the number of treatment-emergent adverse events and adverse reactions for each participant by indication and age group from baseline through the end of the study, which can last up to 316 weeks. Participants' safety and response to long-term treatment will be closely monitored throughout this period.

Researchers are evaluating new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection, focusing on women assigned female at birth who are cisgender. This Phase 3 clinical trial aims to determine whether taking the drug MK-8527 once a month is more effective than the usual daily pre-exposure prophylaxis (PrEP) medication in preventing HIV-1 infection. The study also seeks to understand the safety and tolerability of MK-8527 in this population. Participants will be randomly assigned to receive one of several oral tablets: MK-8527 once monthly, a standard daily PrEP medication called Emtricitabine/tenofovir disoproxil (FTC/TDF), or placebo tablets matched to each drug. This double-blind study compares these groups to assess both the effectiveness and side effects of MK-8527 over time. During the study, participants will be monitored for up to about two years to track new HIV-1 infections, any adverse events they experience, and whether they stop taking the study medication due to side effects. Researchers will regularly evaluate participants' health, safety, and adherence to the treatment plan throughout this period.

Researchers are evaluating how well etavopivat works to reduce the number of vaso-occlusive crises (painful blood vessel blockages) in adolescents and adults living with sickle cell disease. The study also aims to assess if etavopivat can decrease organ damage, improve exercise tolerance, and reduce fatigue. This is a global Phase 3 study involving participants aged 12 years and older with confirmed sickle cell disease. The study is randomized, double-blind, and placebo-controlled to ensure accurate evaluation of the treatment effects. Participants will receive either etavopivat or a matching placebo by mouth. Which treatment they receive is determined randomly. The study will last about two years, during which participants will take the assigned medication and be monitored closely. Etavopivat is an investigational drug currently under evaluation in multiple studies for sickle cell disease. During the study, participants will have regular assessments including documentation of vaso-occlusive crisis events, blood tests, and physical evaluations. Researchers will track the number of crises that require medical attention over a 52-week period, as well as measures of organ health, exercise ability, and fatigue. Safety and overall health will be monitored throughout the study, with the total participation time lasting approximately two years.

Researchers are evaluating the safety, immune response, and effectiveness of a new tuberculosis vaccine called MTBVAC in healthy adolescents and adults aged 14 to 45 years who live in areas where TB is common. This Phase 2b study is randomized, double-blind, and placebo-controlled, involving participants with different immune responses to TB exposure as determined by IGRA testing. The study aims to protect against TB disease confirmed by multiple tests and focuses on those who are HIV-negative. Participants will be randomly assigned to receive either a single intradermal dose of the MTBVAC vaccine or a placebo. The vaccine dose contains approximately 5x10^5 colony-forming units, and the placebo is saline solution, both given as 0.1 mL injections. The study includes two groups based on IGRA status: one with prior immune response to TB and one without, with different randomization ratios. Some participants will be part of safety and immune response sub-cohorts for more detailed monitoring. Throughout the 36-month follow-up, participants will attend regular visits or be contacted to check for signs of TB. They will be trained to recognize TB symptoms and report them for further evaluation, including sputum testing using advanced molecular and culture methods. HIV testing will occur yearly and at times of suspected TB. Safety monitoring includes tracking adverse events and laboratory tests in selected subgroups. Participants diagnosed with TB will be referred for treatment according to local guidelines.

Researchers are evaluating etavopivat, a once-daily oral medicine, in children and adolescents with sickle cell disease. This phase 1/2 study aims to understand the safety of etavopivat and how it behaves in the bloodstream, while also exploring potential benefits for patients. The study focuses on pediatric patients aged from 6 months to under 18 years with confirmed sickle cell disease and severe symptoms. Participants will receive etavopivat tablets by mouth once daily for a continuous 96-week treatment period. After completing treatment, there will be a final study visit four weeks later to assess any lasting effects. The study includes monitoring drug levels in the blood at various points to measure how etavopivat is processed by the body. During the study, participants will have regular assessments to monitor safety and treatment effects, including lab tests to measure drug concentration, and tracking of any side effects or adverse events. Researchers will observe the number of dose changes, interruptions, and early discontinuations throughout the 24-week primary period and beyond. The total study duration includes the 96-week treatment and a 4-week follow-up, with comprehensive monitoring of health status and medication impact.

Researchers are investigating the safety and effectiveness of crizanlizumab compared to a placebo in adolescents and adults aged 12 years and older who have Sickle Cell Disease and experience frequent vaso-occlusive crises (VOCs). This phase III, multicenter, randomized, double-blind study includes patients who have had between 4 and 12 healthcare professional-managed VOCs in the past year. Participants may or may not be taking hydroxyurea or hydroxycarbamide therapy alongside the study treatment. Participants will be randomly assigned in a 2:1 ratio to receive either crizanlizumab at a dose of 5 mg/kg or a placebo, both given as intravenous infusions. The randomization is stratified based on whether they are using hydroxyurea/hydroxycarbamide and by geographic region (South America, North America, and sub-Saharan Africa). Crizanlizumab and placebo are provided in single-use vials for infusion. Treatment will be monitored over a planned period of at least 52 weeks. Throughout the study, participants will be closely monitored for the number of VOCs that require healthcare professional management, including those handled in a healthcare facility or remotely, over one year. Medical history, laboratory tests, and other assessments will be used to document VOCs and evaluate safety. Participants who are on hydroxyurea/hydroxycarbamide or erythropoietin stimulating agents must maintain stable doses during the study. The study aims to assess both the rate of VOCs and the overall safety profile of crizanlizumab in this patient population.

Researchers are evaluating a multisectoral agricultural intervention called Shamba Maisha aimed at improving reproductive and sexual health outcomes among adolescent girls and young women (AGYW) aged 15-19 in Kisumu and Migori counties in Western Kenya. These areas have high rates of HIV and sexually transmitted infections (STIs), as well as widespread food insecurity and poverty. The study focuses on how alleviating food insecurity and poverty through household-level agricultural support might reduce the risk of HIV and STIs and improve mental health among AGYW. The Shamba Maisha intervention includes providing families with water pumps, seeds, and farming tools, along with training on how to use these resources. AGYW will participate in school-based farming activities to develop practical skills and contribute to the school community's food supply. Additionally, the program offers sessions for caregivers and adolescents to improve communication, reduce stress, and discuss important topics such as sexual health. The trial will randomize 20 schools into intervention or control groups and follow 800 AGYW-caregiver pairs for 18 months. Participants will be assessed through surveys and testing for STIs and pregnancy at multiple points over 18 months. Researchers will measure outcomes including STI incidence, household food insecurity, and adolescent depression at 0, 6, 12, and 18 months. The study will also examine caregiver-adolescent relationships, mental health, and program implementation factors. The goal is to create a sustainable intervention that addresses food insecurity and reduces HIV risk among vulnerable AGYW populations.

Neonatal death rates remain very high in sub-Saharan Africa, particularly in Kenya where about 40,000 newborns die annually. Community Health Volunteers (CHVs) play a key role in providing care by conducting monthly home visits to pregnant and postpartum women. Since neonatal illnesses can worsen quickly between visits, this research is testing a digital communication tool to improve timely support for mothers and newborns during this vulnerable period. The study is evaluating CHV-NEO, an interactive two-way SMS messaging platform integrated into the existing digital community health toolkit (dCHT) used by CHVs in Western Kenya. CHV-NEO sends automated daily messages to guide mothers in monitoring newborn danger signs and allows real-time remote communication with CHVs between scheduled home visits. This cluster-randomized trial involves 20 health facility clusters, with half using the CHV-NEO system and half continuing usual care. Participants will be pregnant women between 26 and 36 weeks gestation who have daily access to a mobile phone and plan to stay in the area for at least three months after birth. Researchers will track neonatal mortality within 28 days after birth, clinic visit attendance, and essential newborn care practices. The study also assesses how CHV-NEO affects CHV workflow and its acceptance by users. Mothers will be monitored through SMS interactions and routine health visits during the study period.

Access to safe drinking water remains a major challenge for rural households in developing countries, contributing to millions of deaths worldwide. This research evaluates a program that provides free dilute chlorine solution coupons to pregnant women through health clinics, aiming to improve child health by reducing illnesses such as diarrhea, fever, and cough. The study is a large-scale randomized controlled trial conducted in collaboration with health surveillance sites and the Kenya Medical Research Institute (KEMRI). Participants are divided into two groups: one group receives monthly coupons for free chlorine solutions redeemable at health facilities, while the control group does not receive these coupons. The program's impact is assessed over time by monitoring chlorine use and health outcomes. During the study, researchers collect data on verified chlorine presence in drinking water at 6, 12, 18, 24, 30, and 36 months after the program starts. They also track child health indicators, including self-reported illness rates, clinic visit frequency, child mortality, and verbal autopsies for deceased children. This comprehensive monitoring helps evaluate both the health effects and the program’s sustained use over three years.