Background
In many parts of Africa, private pharmacies are prevalent and commonly accessed but underutilized for PrEP and PEP delivery. Evidence on specific implementation strategies to operationalize pharmacy delivery is lacking.
Methods
The Pharm PrEP cRCT (NCT05842122) randomized 60 pharmacies across 6 Kenyan counties 1:1:1:1 to 4 arms (A): A1) client-sustained delivery: clients (age 16+) paid pharmacies 250 KES (~$2 USD) per PrEP/PEP visit; A2) implementor-sustained delivery: clients paid nothing, and implementors paid pharmacies 250 KES/visit; A3) counselor-supported delivery: clients paid nothing, and implementers stationed counselors in pharmacies to assist with counseling and HIV testing and paid pharmacies 100 KES (~$1 USD)/visit; and A4) referral: clients paid nothing for PrEP/PEP eligibility screening and clinic referral, and implementors paid pharmacies 100 KES/referral. Pharmacies received free commodities from nearby public clinics. Co-primary outcomes were PrEP initiation and continuation (any refills), self-reported in surveys 60 days post-enrollment. Outcomes were modeled as pharmacy-level counts in Poisson generalized linear models accounting for pharmacy client volume and months of implementation, which yielded rate ratios (RRs). A significance threshold of 0.017 accounted for multiple comparisons (A1 vs. A4; A2 vs. A4; A3 vs. A4).
Results
From June 2023-April 2025, 5808 pharmacy clients enrolled (A1: 843; A2: 2254; A3: 2278; A4: 433) at 75 pharmacies, including 15 replacement pharmacies (A1: 5; A2: 2; A3: 3; A4: 5). Most clients were male (54%), unmarried (59%), age 25+ (65%), and PEP candidates (64%). At 60 days, 2214 clients had initiated PrEP (mean pharmacy-standardized annual rate: 24.0 initiations/year) and 803 had continued PrEP (annual rate: 9.1 continuations/year). Compared to referral, PrEP initiation and continuation rates were significantly higher when counselor-supported (initiation: RR 6.9, 95% CI 3.0-16.0, p<0.001; continuation: RR 5.4, 95% CI 1.5-19.1, p=0.009), but not when implementor-sustained (initiation: RR 4.5, 95% CI 1.1-19.3, p=0.04; continuation: RR 4.8, 95% CI 0.7-32.9, p=0.11) or client-sustained (initiation: RR 1.4, 95% CI 0.5-4.0, p=0.52; continuation: RR 0.8, 95% CI 0.2-3.2, p=0.70).
Conclusions
Pharmacy-based PrEP initiation and management engages more eligible clients than clinic referral, particularly when services are fully subsidized and counselor-supported. Governments should consider pharmacies for PrEP service delivery to expand access.