A ProgramPharmacy Chains to Increase PrEP Awareness and Access Among Men - Modified Project Summary/Abstract Section This Type 3 Hybrid Effectiveness-Implementation study will evaluate PrEP & Soccer, a multicomponent and multilevel implementation strategy delivered by a pharmacy chain to increase PrEP knowledge and initial PrEP appointment attendance among PrEP-eligible men. Study Context: The study will be conducted in Miami-Dade, FL, a priority jurisdiction with high HIV rates, particularly among men. Pharmacy chains provide a neutral setting conducive to expanding PrEP knowledge and access. Implementation Strategy: Monitoring & Evaluation: Quality monitoring systems will ensure effective study progress. Colleague Engagement: CVS executives and store managers will review study progress and collaborate on adjustments. Pharmacy Staff Sensitization: Educational materials will train pharmacy staff on HIV prevention and the importance of PrEP for the Miami-Dade community. Sustaining the Strategy: An implementation playbook will be developed to guide the scale-up and sustainability at CVS Health and other pharmacy chains. Streamline Recruitment: PrEP navigators will streamline client enrollment in pharmacy settings. SAFE Training: Our community partner will train PrEP navigators on HIV prevention and client-tailored PrEP navigation. Personalized PrEP Navigation: Client-tailored navigation will promote PrEP knowledge and initial appointment. Insurance & Patient Assistance: Navigators will assist with PrEP cost coverage for all participants (insured, underinsured and uninsured). Marketing Plan: Marketing flyers and an audio series will engage men in PrEP & Soccer. Study Design: Using a parallel cluster randomized controlled design, eight CVS Health pharmacy locations will be assigned to PrEP & Soccer or a general CVS Health service information-only control (four stores in each arm). A total of 800 participants will complete quantitative assessments at baseline, 3- and 6- month follow-ups, while 144 participants will also engage in qualitative interviews. Implementation Aims: Aim 1a. Evaluate PrEP & Soccer’s Reach (extent to which persons at elevated HIV vulnerability initiate participation), and Implementation (extent to which implementation strategies are delivered as designed). Aim 1b. Examine contextual factors associated with Reach and Implementation (e.g., facilitators and barriers; participants’ reactions; what works for whom under what circumstances). Effectiveness Aim: Aim 2. Evaluate effectiveness of PrEP & Soccer on initial PrEP appointment attendance (primary effectiveness outcome), positive movement along the PrEP cascade, and PrEP knowledge (secondary effectiveness outcomes) compared to control. Sustainment & Scale-up Aim: Aim 3. Assess the maintenance, sustainment, and scale-up potential for the strategies by determining (1) cost and needed resources, (2) intent and strategies to sustain and scale using Evidence Based Quality Improvement (EQBI) process, and (3) development of an implementation playbook.
