medRxiv : the preprint server for health sciences · 2026
Effectiveness of pharmacy-based HIV pre- and post-exposure prophylaxis delivery: a cluster-randomized trial in Kenya.
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Ortblad Katrina F, Meisner Allison, Omollo Victor, Kareithi Tabitha, Roche Stephanie D, Ong'wen Patricia, Asewe Magdaline, Anyona Micah Onenga, Banerjee Preetika, Curran Kelly, Gichuru Eunice, Harkey Kendall, Juma Lawerence, Kiptinness Catherine, Malen Rachel C, Mugambi Melissa L, Otieno Peris, Pintye Jillian, Rono Bernard, Schaafsma Torin T, Shah Parth D, Sharma Monisha, Thomas Katherine K, Yu Kaiyue, Were Daniel, Bukusi Elizabeth A, Ngure Kenneth
Аннотация
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.