Fidelity of Implementation of Oral Pre-Exposure Prophylaxis for HIV in Public Family Planning Clinics in Kenya: Results From a Stepped-Wedge Cluster Randomized Trial.

introductionIntegrating HIV pre-exposure prophylaxis (PrEP) into family planning (FP) services offers a strategic opportunity to reach women at risk of HIV acquisition. We assessed fidelity to core components of oral PrEP delivery in real-world FP clinics in Kenya.

methodsData are from the FP Plus Project, a stepped-wedge cluster-randomized trial integrating oral PrEP into 12 public FP clinics in Kisumu, Kenya, where trained FP healthcare providers delivered PrEP services within routine services. Standardized unannounced client actor visits conducted between December 2021 and April 2022, and cross-sectional exit surveys conducted between July 2021 and July 2024 among FP clients were used to evaluate whether the core components of PrEP services were delivered as intended and to assess service quality. Client actors were trained on three case scripts depicting young women in different scenarios: PrEP initiation, PrEP continuation and PrEP during routine FP visits. After each unannounced visit, client actors completed checklists documenting delivery of PrEP services, including behavioural risk assessment, HIV testing, HIV prevention and PrEP counselling, safety assessment, PrEP dispensing and quality-of-care. Data were analysed descriptively.

resultsOverall, 28 client actor visits were completed across participating FP clinics; 12 initiation, 12 continuation and 4 integrated FP-PrEP initiation. Providers assessed at least one HIV risk behaviour in 85.7% (24/28) of visits and discussed at least one HIV prevention strategy in all visits (100%, 28/28). At least one PrEP counselling topic was discussed in 64.3% (18/28) of visits, and one medical safety area was assessed in 42.9% (12/28) of visits. Unprompted PrEP promotion was low at 28.6% (8/28) of visits. Completion of individual items within service components varied widely. Providers were respectful, non-judgemental and used easy-to-understand language in all (28/28) client actor encounters. Of 1801 exit interview participants, 99.8% (1797/1801) discussed at least one HIV prevention strategy and 96.5% (1737/1801) expressed trust in the FP providers.

conclusionsIntegration of oral PrEP provision into routine FP clinics was achieved with varied fidelity across service components. While engagement occurred across PrEP service components, gaps remained in completeness of counselling, PrEP promotion and medical safety assessment, highlighting the need for continued provider support and quality improvement. CLINICAL TRIAL NUMBER: NCT04666792.