Homa Bay

Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 HIV-1. This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is more effective than a daily standard pre-exposure prophylaxis PrEP in preventing HIV-1 infection in women. The study also monitors the safety and tolerability of MK-8527 compared to standard treatment. Participants are randomly assigned to one of two groups one group receives 11 mg of MK-8527 once monthly along with a placebo daily pill resembling EmtricitabineTenofovir Disoproxil Fumarate FTCTDF, and the other group receives the daily FTCTDF pill plus a monthly placebo resembling MK-8527. This treatment phase lasts for up to approximately two years. Afterward, all participants take open-label FTCTDF daily for an additional 28 days. During the study, participants attend regular visits for up to about two years, during which researchers check for new HIV-1 infections, record any adverse events or side effects, and monitor if participants stop the study medication due to side effects. The primary outcomes include the number of participants who acquire HIV-1 infection, those who experience adverse events, and those who discontinue due to adverse events, all tracked over the treatment period.

Researchers are evaluating a two-way text message system called MAMMS IYCF designed to help caregivers of HIV-exposed children aged 6 to 24 months in Kenya monitor and improve their childs nutritional status at home. The study aims to see if this system reduces malnutrition rates, speeds recovery, lowers hospitalizations and deaths, and positively affects caregiver behavior around feeding and healthcare trust. The trial compares this new approach to the standard care following Kenyan national guidelines. Caregiver-child pairs are randomly assigned to either the MAMMS IYCF group or the standard of care group and followed for about six months. In the MAMMS IYCF group, caregivers receive weekly educational messages and are trained to measure their childs arm circumference using MUAC tapes, then report the color outcome via SMS. If a concerning measurement is reported, caregivers are contacted to bring their child for clinical assessment and treatment. The standard care group receives SMS reminders only, with nutritional monitoring and treatment provided during routine clinic visits. Participants attend follow-up visits at 90 and 180 days for medical exams, growth measurements, and surveys on child health and caregiver knowledge. Caregiver experiences with the SMS system are also assessed through questionnaires and interviews. The study tracks outcomes like malnutrition incidence, hospitalizations, deaths, feeding practices, and healthcare trust. All SMS services are free, and caregivers can ask health questions via the messaging system. The total participation lasts around six months with ongoing support and monitoring.

Researchers are studying how linking digital health data systems and involving community teams can improve the number of antenatal clinic ANC visits for pregnant women. This trial, called C-it DU-it, aims to evaluate whether combining data linkage between community and facility health records with active community involvement can increase ANC contacts compared to enhanced standard care. The study is a cluster-randomized controlled trial conducted in Western Kenya to strengthen health systems and support Kenyas goal of achieving eight ANC visits per pregnancy. The trial compares two groups one using digital data linkage between community health information systems and facility electronic medical records C-it, and the other combining this data linkage with trained community Work Improvement Teams WITs that use the data to identify and solve local problems C-it DU-it. The intervention includes building a digital linkage app, training integrated community teams, and implementing community antenatal contacts. The study is open-label and community-based, with ongoing national efforts to scale up digital health systems. Participants are pregnant women living in the study area, including those up to six weeks postpartum. The study lasts 14 months, during which researchers will measure ANC uptake, socioeconomic impacts, costs to women and households, quality of care, birth attendance, and pregnancy outcomes. They will also assess cost-effectiveness and equity of access. Data collection includes facility and community ANC visits, early attendance, and health economic evaluations to inform potential wider scale-up across counties.

Researchers are evaluating three different approaches to testing and managing sexually transmitted infections STIs during pregnancy in Kisumu and Siaya, Kenya. The study aims to compare the effects of these approaches on perinatal outcomes such as pregnancy loss, preterm birth, low birth weight, small size for gestational age, and neonatal death. This randomized controlled trial will involve 3,132 pregnant women receiving antenatal care at selected clinics, with follow-up extending through nine months after delivery. Participants will be randomly assigned to one of three groups standard care involving symptom-based STI management without specific testing for Chlamydia trachomatis CT, Neisseria gonorrhoeae NG, or Trichomonas vaginalis TV universal Xpert4 STI testing regardless of symptoms or Xpert4 testing only for women without STI symptoms. All women diagnosed with STIs or showing symptoms will receive treatment, including expedited partner therapy and tests to confirm cure, following national guidelines. Testing uses a self-collected vaginal swab and is integrated into routine antenatal visits. During the study, participants will undergo regular STI assessments, treatment monitoring, and follow-up visits up to nine months postpartum. Researchers will collect detailed information on demographics, sexual and clinical history, and behavioral factors. Outcomes will be measured at six weeks and nine months postpartum, including STI prevalence, HIV incidence, and quality of care indicators. Participant safety and treatment adherence will be supported with study nurse contact and data monitoring throughout the trial.

Researchers are studying how nutritional supplements made from milk proteins, lactoferrin and lysozyme, may help children aged 6 to 24 months who were hospitalized for diarrhea and have malnutrition. These children are at high risk of repeated diarrhea and poor nutritional recovery despite receiving usual treatments like oral rehydration solutions. The study is a phase 3, double-blind, placebo-controlled randomized trial taking place at seven hospitals in Western Kenya, enrolling 600 participants. Participants will be randomly assigned to receive one of four treatments daily for 16 weeks lactoferrin, lysozyme, a combination of both, or a placebo made of rice powder. Caregivers will mix the assigned supplement with porridge or other complementary foods. After treatment, children will be followed for a total of 24 weeks with clinic visits at weeks 4, 10, 16, and 24, along with bi-weekly home visits by community health workers. During the study, researchers will collect health history information and samples including stool, blood, and possibly urine. They will monitor diarrhea episodes, nutritional recovery, hospitalizations, growth measurements, and markers of intestinal health. Caregivers will report adherence and acceptability of the supplements. The study aims to assess whether these supplements reduce diarrhea recurrence and improve nutrition over six months, while also evaluating safety and cost-effectiveness.