Effectiveness of PrEP product choice on HIV prevention coverage among young women in Kenya seeking reproductive health services

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ABSTRACT Daily oral PrEP has been scaled up in Kenya for numerous populations, including young women with substantial risk for HIV. For many young women who start oral PrEP, numerous studies have demonstrated that discontinuation rates are high and they unlikely benefit from long-term HIV protection. Newer PrEP products that are longer acting, including dapivirine-eluting vaginal rings and intramuscular injections of cabotegravir, offer 1- 2 months of protection and less dependence on the user to remember to take a daily pill. Following WHO guidelines, these products are being integrated into clinical guidelines in Kenya and other countries. For daily oral PrEP, a key strategy for efficient scale up was integration into existing programs, such as those for reproductive health care (e.g., family planning, antenatal, postabortal care) and we have been studying ways to optimize integration of PrEP into these settings. Through implementation science research protocols, we have been working with public clinic staff to introduct PrEP, train providers to delivery PrEP, develop linkages between clinics and national supply chain mechanisms for PrEP, and support providers and programs to overcome challenges. Despite documented high levels of interest in PrEP yielding high frequency of PrEP initiation – 13- 35% of eligible women ages 15-30 years in our family planning and post-abortal clinic partners – we have continued to see high levels of program drop out, non-adherence, and only moderate ability to track whether PrEP is re-started in alignment with fluctuating sexual behavior and potential exposure to HIV. These barriers to PrEP continuation are driven by young women’s needs for PrEP products that afford discretion, convenience, and safety. It is yet unknown whether the availability of multiple HIV PrEP products in a PrEP program will yield a degree of choice, support longer term use of PrEP, and ultimately, greater HIV prevention coverage. Through a multi-step process invoking formative work and a stepped-wedge cluster randomized trial, the research team proposes to determine whether the availability of a suite of PrEP options yields greater HIV protection coverage over a 3- and 6- month period relative to periods when only daily oral PrEP is available. The proposed study aims to: 1) develop a pathway to add injectable cabotegravir and dapivirine ring into existing PrEP services offered through in reproductive health clinics in Kenya leveraging qualitative and community-based research methods, 2) determine whether integration of injectable cabotegravir and dapivirine ring into existing PrEP programs improves PrEP uptake and persistence among young women accessing reproductive health services via a stepped-wedge cluster randomized trial in 12 facilities, and 3) interrogate potential weak points in the PrEP choice intervention including: a) provider hesitancy and client experiences, b) quality of choice-based HIV prevention counseling.