A multi-level intervention to upscale HIV testing and PrEP uptake for men with high HIV exposure via community pharmacies in resource-limited settings - Community pharmacies (CPs) are a promising but underused HIV prevention platform. Pharmacists are often the first point of contact for healthcare in communities where formal health facilities may be less accessible. We have a unique opportunity to efficiently study the potential benefits of pharmacies for HIV prevention in Ghana. Men with increased HIV exposure in Ghana experience a disproportionate HIV burden, with recent data showing HIV prevalence of 26.1% in 2024, up from 18% in 2017, compared with approximately 2% in the general population. Its especially high in urban informal centers, where behavioral exposure, limited HIV knowledge, confidentiality concerns, and constrained access to prevention services reduce HIV testing and PrEP uptake. Ghana, , has adopted national guidelines for HIV self-testing (HIVST) and PrEP and prioritized community-based prevention access. However, implementation remains limited, and existing approaches often emphasize enrollment and distribution targets rather than the behavioral, social, and service-access determinants that shape HIVST, PrEP initiation, and PrEP adherence. Our pilots show that men are willing to receive HIVST and oral or long-acting injectable (LAI) PrEP through CPs and that pharmacists in CPs are willing to provide these services. Yet CP-based implementation has not been systematically tested. To address these gaps, we developed LAFIYA Pharmacy, a multilevel intervention that combines an evidence-based U.S. pharmacy PrEP delivery model with behavioral components from LAFIYA, an intervention developed for urban informal settlement contexts. LAFIYA Pharmacy is designed to address prevention knowledge, service navigation, linkage to care, implementation capacity, and oral or LAI PrEP adherence while expanding confidential access to HIV prevention through CPs. This work tests whether an enhanced U.S. CP-based model can function under conditions where social deterrents, informal settlement conditions, and limited facility engagement shape prevention decisions. Guided by Implementation Science Frameworks, this study will finalize and evaluate LAFIYA Pharmacy to increase HIVST and oral or LAI PrEP uptake among men with increased HIV exposure. Aim 1 will finalize the intervention protocol through focus group discussions with men, community pharmacists, and HIV/pharmacy policy stakeholders, followed by expert and community advisory board review and pilot testing. Aim 2 will evaluate effectiveness using a stepped-wedge design with 12 retail pharmacies, 60 pharmacists, and 240 men across six community clusters, with primary outcomes of HIVST uptake and oral or LAI PrEP uptake. Aim 3 will conduct follow-up qualitative interviews to explain trial findings and inform scalability, sustainability, and integration into national HIV prevention systems. This study will generate implementation evidence on whether CPs can deliver confidential, decentralized HIV testing and PrEP services where facility-based access is constrained. Given the heavy burden of HIV in these populations in Ghana, conduct of the study there will provide time- and cost-efficienies relative to US-based conduct. Findings will inform pharmacy-based HIV prevention in Ghana and provide transferable evidence for U.S. communities where similar determinants limit HIV testing, PrEP initiation, and PrEP persistence.
