PEP/prep via pharmacist-prescribing implementation (peppi)

The National Institute of Mental Health awarded Empowerx, Inc. $485,654 on September 22, 2025, under the Mental Health Research Grants program (CFDA 93.242) to develop and test PEPPI, a software platform that enables community pharmacists to prescribe post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PREP) therapies for HIV prevention.

Phase I of the project applies design thinking methodology—empathize, define, ideate, prototype, and test—to develop a user-informed prototype of the PEPPI software that will support implementation of pharmacist-prescribed PEP/PREP services. Phase II involves development and assessment of the software in real-world community pharmacy settings, with evaluation of its impact on implementation of pharmacist-prescribed PEP/PREP services and patient access. Empowerx will partner with two community organizations, The Source LGBT+ Center and Positively Aware, who will provide feedback on data collection tools, assist with recruitment, and receive regular updates on progress and results throughout both project phases.

The award period of performance runs through August 31, 2026. Work is performed in Del Mar, California. Empowerx is a woman-owned small business.

Abstract

Post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (prep) therapies are highly effective at preventing HIV infections; however, uptake and adherence to these therapies remains low, with only 36% of eligible patients receiving prescriptions.1 with 89% of patients living within five miles of a community pharmacy and pharmacies being over 20 times more available than other prep prescribers across high- priority areas identified by the ending the HIV epidemic initiative,2-3 pharmacists are considered the most accessible health care provider. This positions community pharmacists well to improve PEP/prep access by providing pharmacist-prescribed PEP/prep services. The vast majority of community pharmacists feel pharmacist-prescribed PEP/prep services are important.4-5 and 94% of patients are comfortable receiving prep therapy from a pharmacist.6 however, only between 3% and 11% of community pharmacies in states allowing pharmacist-prescribed PEP/prep services report offering the service.4,7-8 for this project, we will partner with two community organizations, the source lgbt+ center and positively aware, and use a community-based participatory approach. Our community partners will provide feedback on our data collection tools, assist with recruitment, and be informed of our progress and results throughout aims 1 and 2. Phase i (aims 1A and 1B) will follow the first five steps of the design thinking process (empathize, define, ideate, prototype, and test) to develop a user-informed prototype of the peppi software, that will support implementation of effective and sustainable pharmacist-prescribed PEP/prep services. Phase II (aim 2) will involve the development and assessment of the peppi software in a real-world setting (i.e. community pharmacies). We will assess the impact of the peppi software on 1) implementation of pharmacist-prescribed PEP/prep services and 2) patients' access to care via a single-arm clinical trial. The clinical trial will have three consecutive phases where pharmacists provide PEP/prep services under three conditions: 1) control (no peppi software), 2) intervention phase i (peppi minimally viable product [MVP]), and 3) intervention phase II (enhanced peppi software with integrations). At the conclusion of this project, we will have a market-ready, proven, user-informed peppi software application that will facilitate the implementation of pharmacist-prescribed PEP/prep services.