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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

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.

Age: 6Months - 24MonthsAll GendersPhase 3
4 locations
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Actively Recruiting

Healthy Volunteer

This research aims to improve care for youth living with HIV in Kenya by scaling up an evidence-based Adolescent Transition Package ATP. The study evaluates how well a youth-led, data-driven implementation strategy ATP-YES supports the transition from pediatric to adult HIV care compared to the standard of care. It focuses on improving youth readiness to transition, viral suppression, retention in care, and overall health outcomes using a cluster randomized controlled trial design involving 32 clinics across four counties. The study compares two approaches standard of care implementation using a trainer of trainers ToT method and an enhanced ATP-YES strategy that includes youth-led data audits, feedback, and collaborative learning cycles. Existing healthcare workers at clinics will deliver the ATP during routine visits over a 36-month intervention period. Youth aged 10-24 will be offered the ATP, with those aged 15-24 invited to participate in surveys and focus groups. Clinics are randomized 11 to either intervention or control arms. Participants will be involved in surveys, focus groups, and routine medical record reviews. Healthcare workers will provide feedback through interviews and continuous quality improvement activities. The study tracks outcomes such as ATP reach, adoption by providers, fidelity of implementation, viral suppression, retention, and transition readiness over 42 months. Costs and budget impacts of the ATP-YES strategy will also be evaluated. The project includes youth advisory boards and collaboration with Kenyan health authorities to ensure alignment with national priorities.

Age: 10Years +All GendersPhase Not Applicable
25 locations