Leveraging telehealth to optimize PrEP and PEP delivery at pharmacies in Kenya - ABSTRACT Highly effective HIV pre- and post-exposure prophylaxis (PrEP and PEP) have been available at public HIV clinics in Kenya for almost a decade; however, limited opening hours, long wait times, and HIV stigma at clinics have hindered uptake and consistent use of these interventions, thus attenuating their impact on population- level HIV incidence. To increase PrEP/PEP use, the Kenya Ministry of Health (MOH) is interested in expanding delivery to new settings, including private community pharmacies. Our research team recently completed two prospective pilot studies in Kenya to test a novel delivery model in which trained pharmacy providers initiate and manage clients on PrEP and PEP 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: the heavy time burden on pharmacy providers and suboptimal continuation among clients. To understand whether introducing a remote nurse to assist with delivery and provide client support improves clinical and implementation outcomes, we propose conducting a hybrid effectiveness-implementation cluster-randomized controlled trial at 20 pharmacies 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, between visits, communicates with interested clients via 2-way SMS, or 2) standard delivery, where the pharmacy provider performs all delivery tasks and clients are not given additional support. Our primary outcomes will be PrEP/PEP initiations and continuation by 6 months; secondary outcomes will include reach, visit duration, product mix, product switching, and PrEP adherence. In Aim 2, we will evaluate intervention acceptability and feasibility and identify implementation barriers and facilitators using a sequential explanatory mixed methods approach that integrates Aim 1 quantitative findings with qualitative data from routine technical assistance reports, de-identified SMS transcripts, and in-depth interviews (n=81) with clients, pharmacy providers, remote nurses, and key stakeholders. In Aim 3, we will estimate the intervention’s cost-effectiveness and budget impact. In line with recent World Health Organization recommendations, this study will use HIVST to support PrEP delivery and enable client choice by offering multiple types of biomedical HIV prevention products (e.g., daily oral PrEP; on-demand PrEP; PEP). This study will be the first to leverage telehealth for PrEP/PEP delivery in brick-and-mortar pharmacies in Kenya; if found effective, this model has high potential to inform PrEP delivery guidelines in Kenya and other settings where private pharmacies are numerous and highly accessed, but staff typically do not offer services beyond dispensing. Our teams’ extensive experience conducting HIV implementation research in collaboration with the Kenya MOH and our support from national pharmaceutical organizations will ensure the success of this project.
