Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are two drugs that are highly effective at preventing HIV before and shortly after exposure to HIV, respectively; however, in Kenya, PrEP and PEP are mostly only available in public HIV clinics, a place some people may be uncomfortable or unable to easily access. To understand whether and how PrEP and PEP could be delivered in private pharmacies, we propose conducting a four-arm randomized controlled trial in 60 pharmacies spread across Nairobi, Kiambu, Kisumu, and Homabay Counties. We will randomize groups of 15 pharmacies to one of four study arms. In two study arms, we will test a model in which trained pharmacy providers prescribe and refill PrEP and PEP to eligible clients either for a 250 KES fee paid by the client (Arm 1) or for free to the client, with the study paying the fee on the client’s behalf (Arm 2). In pharmacies in a third arm, a trained HIV Testing Services (HTS) counselor will be stationed at the pharmacy and assisting with deliver PrEP/PEP for free to the client (Arm 3), with the study paying the pharmacy 100 KES per client served. Providers in these three intervention arms will have access to a remote clinician whom they can consult, as needed. These three arms will each be compared against a control arm (Arm 4) in which pharmacy providers only screen clients for HIV risk and refer them for free to nearby clinics for PrEP/PEP services. The study will pay pharmacies in the control arm 100 KES per client screened and referred. At 12 months, we will measure how many clients initiated PrEP/PEP, refilled PrEP, and/or initiated PrEP after completing PEP, as well as client and provider perceptions about each model’s acceptability and feasibility. Approximately 16 months into the study, we will present preliminary results to key stakeholders, including the Kenya Ministry of Health (MOH), which will select one model to continue implementing for an additional six months and identify model modifications (e.g., social media campaigns to increase awareness of PrEP/PEP and its availability at study pharmacies) to implement in the remaining three arms over the same six-month period. The findings from this study may help policymakers and funders understand how much demand there is for PrEP/PEP  (and among what populations) at private pharmacies and what benefit, if any, there is to allowing private pharmacies to deliver full PrEP/PEP services (compared to limiting pharmacies to making referrals only) in terms of connecting individuals with HIV risk to these powerful HIV prevention tools.

Pre- and post-exposure prophylaxis (PrEP and PEP) are highly effective HIV prevention methods when taken as recommended. Although over 100 public health facilities across Kenya offer PrEP, initiation at these clinics remains suboptimal due to challenges such as long wait times and stigma. In response, the Kenya Ministry of Health (MOH) is seeking to leverage the private sector to reach individuals who are unable or unwilling to access PrEP in the public sector and has specifically identified private pharmacies as a target PrEP delivery venue. To understand whether and how PrEP and PEP can be delivered in this setting, we will conduct a 16-month, 4-arm cluster randomized control trial. We will randomize 60 pharmacies spread across Nairobi, Kiambu, Kisumu, and Homabay Counties to one of four delivery models. In three models, a trained pharmacy provider (Arms 1 and 2) or an HIV Testing Services counselor (Arm 3) will prescribe and refill PrEP/PEP to eligible clients using a standardized checklist and consultation with a remote clinician, as needed. In Arm 1, clients will pay 250 KES to receive PrEP/PEP; in Arms 2 and 3, the study will pay this fee on the client’s behalf. Each of these arms will be compared a control arm (Arm 4) in which pharmacy providers screen interested clients for HIV risk and refer them for free to traditional clinic-based PrEP/PEP services. Our primary outcomes will be PrEP initiation and continuation (i.e., any refilling) at 60 days following enrollment. Secondary outcomes will include PrEP adherence and PEP-to-PrEP transition. We will also collect client and provider perceptions of acceptability and feasibility. The Kenya MOH will select one model for the study to maintain for an additional six months and identify model modifications (e.g., demand creation strategies) to concurrently implement in the remaining three arms. This study may help elucidate the potential value-add, if any, of expanding PrEP/PEP delivery to private pharmacies.