Rongo

Researchers are evaluating whether nutritional supplements made from milk proteins lactoferrin and lysozyme, alone or combined, can reduce repeated diarrhea episodes and improve nutritional recovery in children aged 6 to 24 months hospitalized with diarrhea and malnutrition in Western Kenya. This Phase 3 randomized, double-blind, placebo-controlled trial aims to address the high risk of illness and death faced by these children despite current diarrhea treatments like oral rehydration solution. The study will enroll 600 children with moderate or severe wasting (MUAC <12.5 cm) to test if these supplements can improve gut health and prevent new disease during a 6-month follow-up period. Participants will be randomly assigned to receive either lactoferrin, lysozyme, a combination of both, or a placebo for 16 weeks. Caregivers will be instructed to mix the supplements daily with their child's porridge or other complementary foods. The study includes bi-weekly home visits by community health workers and clinic visits at 4, 10, 16, and 24 weeks. This design allows monitoring of the supplements' effects and adherence over 6 months. Throughout the study, information on the child's health history will be collected along with stool, blood, and possibly urine samples to evaluate enteric infections, enteric function, and hemoglobin levels. The main outcomes measured are the incidence of moderate-to-severe diarrhea and the time to nutritional recovery over 6 months. Safety and acceptability will be assessed, and caregivers' adherence to the supplements will be monitored. The results aim to inform new strategies to reduce mortality and complications in malnourished children recovering from diarrhea.

Researchers are evaluating a youth-led, data-driven implementation strategy to expand an evidence-based Adolescent Transition Package (ATP) designed to improve the transition from pediatric to adult HIV care for youth living with HIV in Kenya. This study builds on a previous trial and aims to improve the number of youth receiving the ATP, provider adoption, and consistent use of the ATP over time. The study also assesses the cost-effectiveness of this implementation approach and its impact on health outcomes such as viral suppression and retention in care. The study will involve 32 HIV clinics randomized to either the standard of care implementation strategy (Trainer of Trainers) or an enhanced strategy called ATP-Youth Enhanced Strategy (ATP-YES), which adds youth-led data audits, feedback, and collaborative learning. The ATP is delivered by healthcare workers during routine clinic visits for youth aged 10 to 24 years. Older youth (15-24 years) will participate in surveys and focus groups, while healthcare workers will engage in surveys, interviews, and quality improvement activities throughout the 36-month study period. Participants will have their routine medical records reviewed, and healthcare workers and youth will provide feedback on implementation experiences. The study will measure outcomes including ATP reach, effectiveness on viral suppression and retention, adoption by healthcare workers, fidelity to ATP processes, and maintenance of the intervention. Costs and budget impact will also be examined over the 42 months from enrollment through 6 months after study end.