{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T07:01:14Z","timestamp":1784876474989,"version":"3.55.0"},"posted":{"date-parts":[[2026,6,29]]},"group-title":"Public and Global Health","reference-count":58,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T00:00:00Z","timestamp":1782691200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Gates Foundation","award":["INV-0330520"],"award-info":[{"award-number":["INV-0330520"]}]},{"DOI":"10.13039\/100000025","name":"National Institutes of Mental Health","doi-asserted-by":"crossref","award":["R00 MH121166"],"award-info":[{"award-number":["R00 MH121166"]}],"id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2026,6,29]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                <jats:p>\n                  Private pharmacies are ubiquitous yet underutilized for HIV pre- and post-exposure prophylaxis (PrEP and PEP) delivery. In a cluster-randomized trial in Kenya (\n                  <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05842122\">NCT05842122<\/jats:ext-link>\n                  ), we randomized 60 pharmacies 1:1:1:1 to: client-sustained delivery (\u223c$2\/visit user fee); implementor-sustained delivery (\u223c$2\/visit reimbursement); counselor-supported delivery (task shifting; \u223c$1\/visit reimbursement); or clinic referral (control; \u223c$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&lt;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.\n                <\/jats:p>","DOI":"10.64898\/2026.06.26.26356703","type":"posted-content","created":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T23:35:11Z","timestamp":1782776111000},"source":"Crossref","is-referenced-by-count":0,"title":["Effectiveness of pharmacy-based HIV pre- and post-exposure prophylaxis delivery: a cluster-randomized trial in Kenya"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5675-8836","authenticated-orcid":false,"given":"Katrina F.","family":"Ortblad","sequence":"first","affiliation":[{"name":"Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5177-7635","authenticated-orcid":false,"given":"Allison","family":"Meisner","sequence":"additional","affiliation":[{"name":"Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9655-7821","authenticated-orcid":false,"given":"Victor","family":"Omollo","sequence":"additional","affiliation":[{"name":"Centre for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-4907-7494","authenticated-orcid":false,"given":"Tabitha","family":"Kareithi","sequence":"additional","affiliation":[{"name":"Partners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7569-3241","authenticated-orcid":false,"given":"Stephanie D.","family":"Roche","sequence":"additional","affiliation":[{"name":"Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0246-6640","authenticated-orcid":false,"given":"Patricia","family":"Ong\u2019wen","sequence":"additional","affiliation":[{"name":"Jhpiego Kenya, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdaline","family":"Asewe","sequence":"additional","affiliation":[{"name":"Centre for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-7005-0007","authenticated-orcid":false,"given":"Micah Onenga","family":"Anyona","sequence":"additional","affiliation":[{"name":"Jhpiego Kenya, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6129-5020","authenticated-orcid":false,"given":"Preetika","family":"Banerjee","sequence":"additional","affiliation":[{"name":"CHOICE Institute, Department of Pharmacy, University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-6303-7432","authenticated-orcid":false,"given":"Kelly","family":"Curran","sequence":"additional","affiliation":[{"name":"Johns Hopkins School of Medicine, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eunice","family":"Gichuru","sequence":"additional","affiliation":[{"name":"Partners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-0725-9244","authenticated-orcid":false,"given":"Kendall","family":"Harkey","sequence":"additional","affiliation":[{"name":"Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawerence","family":"Juma","sequence":"additional","affiliation":[{"name":"Centre for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2647-0196","authenticated-orcid":false,"given":"Catherine","family":"Kiptinness","sequence":"additional","affiliation":[{"name":"Partners in Health Research and Development, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-7262-9029","authenticated-orcid":false,"given":"Rachel C.","family":"Malen","sequence":"additional","affiliation":[{"name":"Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8875-5528","authenticated-orcid":false,"given":"Melissa L.","family":"Mugambi","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peris","family":"Otieno","sequence":"additional","affiliation":[{"name":"Centre for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1255-7191","authenticated-orcid":false,"given":"Jillian","family":"Pintye","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"Rono","sequence":"additional","affiliation":[{"name":"Centre for Microbiology Research, Kenya Medical 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