Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 12, 2025
Date Accepted: Mar 20, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Evaluation of a Collaborative Practice Agreement Intervention to Improve Access to HIV Prevention Services in Southeastern U.S. Pharmacies: Protocol for a Hybrid Type 1 Effectiveness-Implementation Study
ABSTRACT
Background:
The United States (US) Southeast experiences a disproportionate burden of HIV, compounded by limited access to pre-exposure prophylaxis (PrEP) services due to systemic barriers such as stigma, medical mistrust, and restrictive pharmacy policies. Collaborative Practice Agreements (CPAs) between pharmacists and clinicians represent a promising strategy to improve PrEP accessibility through pharmacy-based services
Objective:
The Collaborative Agreement-based PrEP Using Pharmacies (CAP-UP) study aims to evaluate the development, implementation, and effectiveness of a CPA template and training resources to enhance pharmacy-based PrEP initiation and adherence in the Southeastern US.
Methods:
The CAP-UP study employs a hybrid type 1 effectiveness-implementation design guided by integrated implementation science frameworks. It includes three phases: (1) Exploration, using online surveys and in-depth interviews to identify barriers and facilitators to CPA implementation; (2) Preparation, developing and refining a CPA template and training resources; and (3) Implementation, piloting the CPA template in 10 community pharmacies within high-HIV-prevalence neighborhoods.
Results:
The CAP-UP study was funded in October 2023 by [the National Institutes of Health (NIH) through the Center for AIDS Research (CFAR) grant [P30-AI050409-25S1] as an Ending the HIV Epidemic Supplement. Recruitment launched in November 2023 and is actively ongoing, with 262 pharmacy staff having completed surveys as of April 2025. The study aims to recruit a total of 300 participants for surveys and conduct 68 in-depth interviews by June 2025.
Conclusions:
Expanding HIV prevention services through community pharmacies represents a practical and impactful strategy for addressing inequities in HIV prevention that advances health equity. By leveraging implementation science frameworks, our study explores a novel approach to integrating HIV prevention services in pharmacies located in high-HIV-prevalence areas. Findings from this work will contribute to the evidence base needed to optimize pharmacy-based PrEP delivery and support the national goal of Ending the HIV Epidemic in the US
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