ABSTRACT Women in HIV high burden settings are a priority population for HIV prevention, because they carry disproportionately high fraction of new HIV infections. A recent large clinical study (ECHO Study) in four African countries found that incident HIV infections were unacceptably high among women desiring contraception– an average of 3.8%. These results have rightly spurred discussions about the need to strengthen integration of HIV prevention and sexual reproductive health services. Oral pre-exposure prophylaxis (PrEP) is an attractive user- controlled HIV prevention strategy, given its high effectiveness and safety. Integrating HIV prevention services, including PrEP provision into care settings that women trust and access routinely may offer an efficient platform to reach at-risk women for HIV prevention. In a recent pilot study, we demonstrated that it was feasible to integrate PrEP provision in FP clinics with program-dedicated staff. However, that approach also highlighted the need for delivery models that integrate efficiently with existing staff for sustainability. With a multidisciplinary team and drawing from lessons from the pilot work, we propose to catalyze scale up PrEP provision for at-risk women accessing FP clinics in Kisumu, Kenya – a region with an HIV prevalence of up to 28% among young women. We will aim for a sustainable, institutionalized, and cost- and time-efficient PrEP delivery in FP clinics. We hypothesize that FP clinics will provide woman-centered ‘one-stop’ location for PrEP and FP services that could address barriers women face to access HIV prevention services, including lack of time, cost, and stigma of visiting a facility solely for HIV prevention. We will conduct a step-wedged cluster-randomized trial to test a multifaceted implementation strategy in 12 FP clinics (n=3600 women) with the following Aims: In Aim 1, we will deliver PrEP in public health FP clinics in staged fashion, implementing and optimizing HIV prevention service provision with existing FP clinic staffing. We will rigorously evaluate program reach, effectiveness, adoption, implementation, maintenance, and impact using the RE-AIM framework. The multifaceted implementation strategy to integrate PrEP in FP clinics will include: 1) provider training; 2) promotion of HIV testing, partner HIV testing, screening for HIV and STIs risk and offer of PrEP; 3) ongoing technical assistance; 4) Audit and feedback to optimize delivery; 5) work-flow mapping; and 6) streamlined data and PrEP supply systems. In Aim 2, guided by the Organizational Readiness for Implementing Change and the Consolidated Framework for Implementation Science Research, we will assess readiness to implement, fidelity, impact on current services, facilitators, and barriers to integration PrEP provision in FP clinic context. In Aim 3, we will assess programmatic cost, budget impact, and affordability of integrating PrEP delivery in FP clinics in Kenya. Costs will be estimated over a 5 year horizon considering the payer’s perspective as well as societal perspective to account for client opportunity and financial costs. The results of this project will lay the ground for wider scale delivery of oral PrEP and next- generation PrEP formulations in FP clinics, not only in Kenya but in other resource-limited settings globally.

PROJECT NARRATIVE Pre-exposure prophylaxis (PrEP) is a highly effective user-controlled HIV prevention strategy, with tremendous potential for high impact to reduce incident HIV infections among at-risk African women if delivered with high coverage and taken with sufficient adherence. In this highly innovative study, we propose to catalyze integration of optimized universal screening and counseling for HIV risk behaviors and PrEP provision for at-risk women accessing public health family planning clinics in Kisumu, Kenya – a region with an HIV prevalence of up to 28% among young women– using step-wedged randomized design. We hypothesize that family planning clinics will offer a cost- and time-efficient, less stigmatizing, and sustainable woman-centered ‘one-stop’ access point for PrEP and FP services, with culminating in great reach and impact for PrEP of reducing incident HIV infection in this setting.