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dc.contributor.authorAlbert Y. Liuen_US
dc.contributor.authorAliza Norwooden_US
dc.contributor.authorHolly Gundackeren_US
dc.contributor.authorAlex Carballo-Diéguezen_US
dc.contributor.authorSherri Johnsonen_US
dc.contributor.authorKaren Pattersonen_US
dc.contributor.authorLinda Gail Bekkeren_US
dc.contributor.authorSuwat Chariyalertsaken_US
dc.contributor.authorAnupong Chitwarakornen_US
dc.contributor.authorPedro Gonzalesen_US
dc.contributor.authorTimothy H. Holtzen_US
dc.contributor.authorKenneth H. Mayeren_US
dc.contributor.authorCarmen Zorrillaen_US
dc.contributor.authorSusan Buchbinderen_US
dc.contributor.authorJeanna M. Piperen_US
dc.contributor.authorJavier R. Lamaen_US
dc.contributor.authorRoss D. Cranstonen_US
dc.description.abstractBACKGROUND: As daily oral preexposure prophylaxis (PrEP) becomes standard for HIV prevention, routine use of PrEP is likely to increase within clinical trials of novel preventive agents. We describe the prevalence and characteristics of participants reporting nonstudy oral PrEP use within Microbicide Trials Network-017 (MTN-017), a phase 2 trial of a rectal microbicide. SETTING AND METHODS: One hundred ninety-five HIV-uninfected men who have sex with men and transgender women were enrolled and followed in MTN-017 across 8 sites in the United States, Thailand, South Africa, and Peru from 2013 to 2015. Nonstudy oral PrEP use was recorded on case report forms and progress notes. Characteristics of PrEP users and non-PrEP users were compared using tests of statistical significance. RESULTS: Overall, 11% of participants reported nonstudy oral PrEP use, all from the San Francisco (SF) site, accounting for 58% (22/38) of participants enrolled in SF. There was a higher median number of sex partners reported in the past 8 weeks before enrollment among oral PrEP users vs. nonusers (7 vs. 2, P = 0.02). Most PrEP users (18/22, 82%) began PrEP treatment during screening/after enrollment, and most (19/22, 86%) decided to continue oral PrEP after study completion. CONCLUSION: Nonstudy oral PrEP use in the first phase 2 study of tenofovir reduced-glycerin 1% gel was high at a single site in SF where community PrEP availability and use was expanding. Investigators should consider the evolving context of nonstudy oral PrEP use across trial sites when designing and interpreting trials of novel biomedical prevention modalities.en_US
dc.titleBrief Report: Routine Use of Oral PrEP in a Phase 2 Rectal Microbicide Study of Tenofovir Reduced-Glycerin 1% Gel (MTN-017)en_US
article.title.sourcetitleJournal of acquired immune deficiency syndromes (1999)en_US
article.volume81en_US of Puerto Ricoen_US Francisco Department of Public Healthen_US York State Psychiatric Instituteen_US for Disease Control and Preventionen_US Institute of Allergy and Infectious Diseasesen_US Ministry of Public Healthen_US of Pittsburghen_US of Texas at Austinen_US Hutchinson Cancer Research Centeren_US Mai Universityen_US of Cape Townen_US Civil Impacta Salud y Educacionen_US Healthen_USón Civil Impacta Salud y Educaciónen_US
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