In 2015 the WHO recommendedtaking daily oral PrEP containing ARV based medication used for treatment of HIV for the prevention of HIVin individuals at considerable HIV risk. Demonstration PrEP studies showed very high use, adherence, and successof PrEP medication taken by couples in HIV serodiscordant relationships;men who have sex with men in the Americas and Europe.Kenya last year launched the national Guidelines on Use of PrEP for preventing HIV infection. PrEP is safe and effective and is registered for use by the Pharmacy and Poisons Board in Kenya.Despite these milestones, PrEP is not widely available to young women in part due to policymaker’s need for delivery strategies that effectively reach those at highest risk of HIV, Therefore, effective delivery models for PrEP are needed to determine PrEP use and adherence in these young women who are at highest risk of HIV infection and are motivated to take PrEP, sustain high adherence so long as they remain at risk.

The World Health Organization recommends daily oral PrEP containing tenofovir for the prevention of HIV infection in persons at substantial HIV risk. Open label PrEP studies have demonstratedvery high uptake, adherence, and effectiveness of oral PrEP in heterosexual African HIV serodiscordant couples and men who have sex with men in the Americas and Europe. The first open-label study of oral PrEP among young women in a township near Cape Town, South Africa also demonstrated high adherence. However, PrEP has not been delivered to women in many African settings, and effective delivery models for PrEP are needed. Young African women are an important population for PrEP implementation, with one of the highest annual HIV incidence rates globally, even in recent HIV prevention trials which provided the best available standard of prevention services (condoms, STI services, and counseling). Women between the ages of 16 and 24represent three of the four million young people living with HIV in Africa. Given the high HIV incidence and evidence for high effectiveness of PrEP when adherence to product use is high, PrEP delivery, uptake and adherence need to be evaluated among young African women.The impact will be greatest if the subset of young women who are at highest risk of HIV infection are motivated to use PrEP and are able to establish daily pill-taking habits and sustain high adherence while they remain at risk. This protocol describes an implementation science study of PrEP delivery to young women in South Africa and Kenya. Oral PrEP delivery has been defined as an emerging part of standard of care (SOC) for HIV prevention in Kenya and South Africa. Both Kenya and South Africa regulatory authorities have approved an indication for PrEP for the combination medication tenofovir disoproxil fumarate / emtricitabine (TDF/FTC), based on clinical safety and efficacy data.Onto HIV SOC that includes PrEP, we propose to conduct an open cohort study to evaluate oral PrEP uptake and use as well as delivery efficiency. The prospective cohort study will enroll sexually active HIV negative women ages 16-25 in Cape Town, South Africa, Kisumu, Kenya, and Johannesburg, South Africa. Uptake of and adherence to PrEP, when presented as a SOC option, will be assessed, as will the delivery of the SOC PrEPpackage itself.