Evaluating HIV Testing Counselor-led PrEP Delivery to Support HIV Prevention in Kenyan Family Planning Clinics

What this Trial Is About

Researchers are studying the introduction of HIV testing services HTS counselor-led Pre-exposure Prophylaxis PrEP care in public family planning clinics in Kenya. This cluster randomized, stepped wedge study evaluates how delivering PrEP through HTS counselors affects HIV prevention efforts in these clinics. The study aims to improve integration of PrEP services into existing healthcare settings to support prevention of HIV infection. The study compares two periods a control period where clinics continue usual care with no counselor-led PrEP delivery, and an intervention period where HTS counselors provide all core PrEP services including HIV testing, eligibility assessment, medication dispensing, adherence counseling, and refills. A baseline phase of 3 months precedes the intervention to establish usual care standards. The intervention is delivered as part of the standard care by existing clinic staff. Participants are individuals aged 15 years and older accessing services at participating public health facilities who are not known to be living with HIV at study start. Researchers will monitor PrEP screening, initiation, and continuation over up to 42 months. Data collection includes tracking delivery of PrEP care by HTS counselors and participant adherence. The study runs from December 2025 through June 2029, with primary outcome data expected by December 2028.

HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics