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

作者：Katrina F. Ortblad, Allison Meisner, Victor Omollo, Tabitha Kareithi, Stephanie D. Roche, Patricia Ong’wen, Magdaline Asewe, Micah O. Anyona, Preetika Banerjee, Kelly Curran, Eunice Gichuru, Kendall Harkey, Lawrence Juma, Catherine Kiptinness, Rachel C. Malen, Melissa Latigo Mugambi, Peris Otieno, Jillian Pintye, Bernard Rono, Torin Schaafsma, Parth D Shah, Monisha Sharma, Katherine K. Thomas, Kaiyue Yu, Daniel Were, Elizabeth A. Bukusi, Kenneth Ngure · 发表于：medRxiv · 年份：2026 · DOI：10.64898/2026.06.26.26356703 · 研究领域：HIV/AIDS Research and Interventions、HIV, Drug Use, Sexual Risk、HIV/AIDS drug development and treatment

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.