PEP/PrEP via Pharmacist-Prescribing Implementation (PEPPI)

/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. Project Number: 1R44MH142152-01 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: Sally Rafie (+1 co-PI) | Institution: EMPOWERX, INC., Del Mar, CA | Award Amount: $242,827 | Activity Code: R44 | Study Section: Special Emphasis Panel[ZMH1 ERB-N (07)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11253772