Leveraging Telehealth to Optimize HIV PrEP and PEP Delivery at Private Pharmacies - ABSTRACT Highly effective HIV pre- and post-exposure prophylaxis (PrEP and PEP) have been available at health facilities for nearly a decade; however, access barriers—limited opening hours, long wait times, and HIV stigma—have hindered uptake and consistent use, attenuating their impact on population-level HIV incidence. To increase PrEP/PEP use, the U.S. Government and Kenya Ministry of Health (MOH) are interested in expanding delivery to new settings, including private pharmacies. Our research team recently completed two pilot studies in Kenya testing a novel delivery model in which trained pharmacy providers initiate and manage PrEP/PEP clients under remote clinician supervision (NIH R34 MH120106, PI: Ortblad; BMGF INV-033052, MPIs: Ortblad/Bukusi/Ngure). This model reached PrEP- and PEP-eligible individuals and was highly acceptable to providers and clients; however, two key implementation challenges emerged: provider time burden and suboptimal client continuation. Addressing these challenges will inform the scale-up of pharmacy PrEP/PEP services globally. We propose introducing a remote nurse to assist providers with delivery and support clients between visits, tested in a hybrid effectiveness-implementation cluster-randomized controlled trial in Kisumu and Homa Bay Counties (Western Kenya). In Aim 1, we will 1:1 randomize 20 pharmacies (n=1,580 clients ≥15 years) to either: 1) telehealth support, where a remote nurse screens, counsels, and guides clients through HIV self-testing (HIVST) and communicates with interested clients via 2-way SMS between visits, or 2) standard delivery, where the pharmacy provider performs all tasks and clients are not given additional support. Primary outcomes are pharmacy-level PrEP/PEP initiation and continuation at 18 months post-implementation; secondary outcomes include reach, visit duration, product mix, product switching, and PrEP adherence. In Aim 2, we will evaluate acceptability and feasibility and identify implementation barriers and facilitators using a sequential explanatory mixed methods approach integrating Aim 1 quantitative findings with qualitative data from technical assistance reports, SMS transcripts, and in-depth interviews (n=81) with clients, pharmacy providers, remote nurses, and key stakeholders. In Aim 3, we will estimate the cost-effectiveness and budget impact of the intervention. Consistent with recent World Health Organization recommendations, this study will use HIVST to support PrEP delivery and offer multiple biomedical HIV prevention options (e.g., daily oral PrEP; on-demand PrEP; PEP). This first-ever study of telehealth-supported pharmacy PrEP/PEP delivery will generate timely, robust evidence to inform guidelines in the U.S., Kenya, and other settings where HIV services are limited and pharmacy-based delivery is prioritized. Conducting this research in Kenya, where HIV prevalence is high and pharmacy-based PrEP/PEP is well-established, will maximize the speed and efficiency of evidence generation. This study directly addresses NIH priorities in HIV implementation science and pharmacy-based HIV service delivery. Our team's extensive experience collaborating with the Kenya MOH HIV research will ensure project success.
