Effectiveness of pharmacy-based HIV pre- and post-exposure prophylaxis delivery: a cluster-randomized trial in Kenya.

Private pharmacies are ubiquitous yet underutilized for HIV pre- and post-exposure prophylaxis (PrEP and PEP) delivery. In a cluster-randomized trial in Kenya (NCT05842122), we randomized 60 pharmacies 1:1:1:1 to: client-sustained delivery (~$2/visit user fee); implementor-sustained delivery (~$2/visit reimbursement); counselor-supported delivery (task shifting; ~$1/visit reimbursement); or clinic referral (control; ~$1/referral reimbursement). Commodities were supplied free to pharmacies from government stock. Primary outcomes were PrEP initiation and one-month continuation (any dispensing or refilling, respectively), self-reported by clients 60 days post-enrollment (multiple-comparisons threshold: p=0.017). From June 2023-April 2025, 5,808 clients enrolled; 64% were PEP candidates. Compared to referral, the counselor-supported arm had significantly higher PrEP initiation (RR=6.5, 95% CI [2.6, 16], p<0.001) and continuation rates (RR=5.1, 95% CI [1.4, 19], p=0.016); all intervention arms had significantly higher PEP initiation rates. One seroconversion, one social harm, and two provider needlestick injuries occurred. Pharmacy PrEP/PEP delivery outperformed clinic referral, particularly when fully subsidized and counselor-supported.