{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:44:54Z","timestamp":1792025094113,"version":"4.4.0"},"reference-count":47,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R21 MH136855"],"award-info":[{"award-number":["R21 MH136855"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["T32 AI007433"],"award-info":[{"award-number":["T32 AI007433"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pre-exposure prophylaxis (PrEP) prevents HIV acquisition, but its population-level impact is limited by access barriers. Low-barrier delivery of daily oral tenofovir disoproxil fumarate\/emtricitabine (TDF\/FTC), such as over-the-counter (OTC) availability, could improve access by eliminating clinic visits, though reduced monitoring may increase risks including drug resistance, renal toxicity, and hepatitis B virus (HBV) reactivation. We estimated the benefits and risks of OTC PrEP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Using a stochastic network-based model of HIV\/STI transmission among gay, bisexual, and other men who have sex with men (GBMSM) in Atlanta, we simulated 2 delivery pathways: clinic-based PrEP and OTC PrEP with simplified initiation and reduced monitoring. We modeled 10%\u201350% increases in PrEP coverage over 10 years. Outcomes included HIV infections averted, STI incidence, contraindicated PrEP use (GFR &amp;lt;60 mL\/min\/1.73 m2), HBV reactivations, and drug resistance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>By expanding coverage, OTC PrEP reduced HIV incidence across all scenarios. A 50% coverage increase averted 15.4% of HIV infections. However, clinical risks increased: renal impairment exposure rose from 2.5% to 4.8%; HBV reactivations reached 2.27 per 100 person-years; and TDF\/FTC resistance rose from 0.68 to 8.40 events per 100 incident HIV infections. In sensitivity analyses, confirming HIV-negative status at initiation reduced resistance by &amp;gt;90% without reducing prevention benefits, and frequent renal-monitoring reduced renal risk.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>OTC PrEP could produce population-level HIV prevention benefits if it expands coverage beyond clinic-based care. However, its net public health impact depends on implementation choices that preserve safety functions, particularly HIV testing at initiation and renal monitoring, without undermining access gains.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiag369","type":"journal-article","created":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T11:46:30Z","timestamp":1784115990000},"page":"519-529","source":"Crossref","is-referenced-by-count":0,"title":["Potential Risks and Benefits of Low-barrier Access and Monitoring for HIV Pre-exposure Prophylaxis: A Modeling Study"],"prefix":"10.1093","volume":"234","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4791-418X","authenticated-orcid":false,"given":"Adrien V","family":"Le Guillou","sequence":"first","affiliation":[{"name":"Department of Epidemiology, Rollins School of Public Health, Emory University , Atlanta, Georgia ,","place":["USA"]},{"name":"UR3797 VieFra, Faculty of Medicine, University of Reims Champagne-Ardenne , Reims ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia L","family":"Marcus","sequence":"additional","affiliation":[{"name":"Department of Population Medicine, Harvard Medical School , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4027-472X","authenticated-orcid":false,"given":"Douglas S","family":"Krakower","sequence":"additional","affiliation":[{"name":"Department of Population Medicine, Harvard Medical School , Boston, Massachusetts ,","place":["USA"]},{"name":"Beth Israel Deaconess Medical Center Division of Infectious Diseases, Department of Medicine, , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren R","family":"Violette","sequence":"additional","affiliation":[{"name":"Department of Population Medicine, Harvard Medical School , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8840-105X","authenticated-orcid":false,"given":"Samuel M","family":"Jenness","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Rollins School of Public Health, Emory University , Atlanta, Georgia ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,7,17]]},"reference":[{"key":"2026101419575406200_jiag369-B1","volume-title":"Ending the HIV epidemic in the U.S.: goals [internet]","author":"Centers for Disease Control and Prevention","year":"2025"},{"key":"2026101419575406200_jiag369-B2","doi-asserted-by":"crossref","first-page":"1778","DOI":"10.1007\/s12325-020-01295-0","article-title":"Barriers to the wider use of pre-exposure prophylaxis in the United States: a narrative review","volume":"37","author":"Mayer","year":"2020","journal-title":"Adv Ther"},{"key":"2026101419575406200_jiag369-B3","doi-asserted-by":"crossref","first-page":"3152","DOI":"10.1093\/cid\/ciz1236","article-title":"Has pre-exposure prophylaxis made a difference at a population level? 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