Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 6, 2025
Date Accepted: Aug 31, 2025
Improving Access to HIV Prevention Services in Community Pharmacies in the U.S. Southeast: Protocol for a Hybrid Type 1 Effectiveness-Implementation Study
ABSTRACT
Background:
Despite advancements in HIV prevention, many Americans, particularly those from historically underserved communities (e.g., racially and sexually minoritized individuals and people who use drugs), continue to face significant barriers to accessing crucial HIV prevention services such as HIV testing and pre-exposure prophylaxis (PrEP). Integrating these services into community pharmacies is a viable yet underutilized solution to overcoming access-related challenges. However, few studies have used an implementation science approach to assess the implementation and effectiveness of such services in pharmacy settings.
Objective:
The Pharmacy-based Access to HIV Prevention Services (PATH) study aims to develop and evaluate a sustainable pharmacy-based model for increasing access to HIV testing and prevention services (e.g., PrEP dispensing) in community pharmacy settings.
Methods:
We are using a hybrid type 1 effectiveness-implementation study design to evaluate the implementation and effectiveness of HIV testing and prevention services within community pharmacies, particularly among those that offer non-HIV-related screenings (e.g., COVID-19, blood pressure, cholesterol screening) and those that do not. We apply three well-established implementation science frameworks (i.e., Exploration, Preparation, Implementation, Sustainment (EPIS), Consolidated Framework for Implementation Research (CFIR), and Systems Engineering Initiative for Patient Safety (SEIPS)) to assess multi-level factors influencing the adoption of HIV prevention services in community pharmacy settings. The study consists of three phases: (1) a mixed-methods exploration phase to identify barriers and facilitators of implementing HIV prevention services in community pharmacies, (2) a preparation phase to assess the effectiveness of two HIV training programs designed for pharmacy staff, and (3) an implementation and sustainment phase to evaluate the effectiveness and implementation of HIV prevention services in these settings.
Results:
The PATH study was funded in June 2023 by the National Institute of Mental Health (R01MH123470) and launched in September 2023. Recruitment and enrollment for the first phase, including data collection, are currently underway.
Conclusions:
Expanding access to HIV prevention services through community pharmacies is a promising and accessible approach to addressing social and health inequities in HIV, supporting the goal of Ending the HIV Epidemic in the United States (US). Implementation science, with its systematic frameworks, is essential to advancing this goal. Our study is among the first to use an implementation science approach to integrate HIV prevention services within community pharmacies in high-prevalence HIV areas.
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