PrEP My Way: A hybrid type 1 clinical effectiveness-implementation trial to promote PrEP persistence among young Kenyan women - PROJECT SUMMARY. Significance: Young women account for 63% of all new HIV infections in sub-Saharan Africa and are thus a high priority population for pre-exposure prophylaxis (PrEP). Because adherence and persistence to PrEP as oral emtricitabine/tenofovir have generally been low, new interventions are needed to facilitate PrEP use. Injectable cabotegravir (CAB-LA) and the dapivirine vaginal ring, as well as choice of adherence support, are promising approaches to increase PrEP use; however, a key remaining need is a mechanism to effectively engage with young women over time. Intervention: PrEP My Way is a novel PrEP delivery system based on Social Cognitive Theory involving clinic-based PrEP initiation, followed by peer- delivered kits for HIV self-testing, PrEP refills, vaginal swabs for sexually transmitted infection (STI) self- sampling, pregnancy tests, and family planning, if desired. Pilot research demonstrated high feasibility and acceptability of PrEP My Way as an effective means to engage young women in care. PrEP use was modest overall although improved compared to clinic-based delivery. When combined with choice of PrEP formulation and adherence support tools, PrEP My Way is well positioned to create an optimized means to promote PrEP use for young women in sub-Saharan Africa. Innovation: PrEP My Way is the first, to our knowledge, peer- delivered kit for holistic sexual health services that enables choice of PrEP formulation and adherence support, combining key complementary evidence-based approaches for promoting PrEP use among young women. Approach: In Aim 1, we will augment PrEP My Way to include CAB-LA and the dapivirine vaginal ring, as well as choice of peer-based adherence support (SMS, routine check-ins, or WhatsApp groups). In Aim 2, we will conduct a type 1 effectiveness-implementation trial of PrEP My Way vs enhanced standard of care in Kisumu, Kenya in 432 young women over 1 year. We will assess the intervention with and without STI testing to assess the marginal impact of the most costly kit component beyond PrEP. Our primary outcome will be prevention- effective PrEP persistence (i.e., continued use by those with ongoing HIV prevention needs) by documented injection (CAB-LA) or drug levels (ring, oral) at Month 9. Secondary outcomes will be prevention-effective persistence and adherence at other time points, STI testing, and use of family planning. We will also track implementation, service, and participant metrics using the Proctor framework. In Aim 3, we will conduct cost and cost-effectiveness analyses of the intervention with and without STI testing. Investigators/environment: Our team has the critical expertise needed for the success of this proposal: PrEP adherence/persistence and implementation science (Dr. Haberer), PrEP/sexual health service delivery (Dr. Bukusi), PrEP formulation and adherence support choice (Dr. Ngure), cost-effectiveness analysis (Dr. Barnabas), and intervention design (ARK Africa, Dr. Siegler). Future directions: The Kenya National AIDS/STD Control Program (Dr. Wafula) will be involved with all stages of this proposal to facilitate rapid integration and scale-up should it prove effective.
