Albert Y Liu1, Aliza Norwood1,2, Holly Gundacker3, Alex Carballo-Diéguez4, Sherri Johnson5, Karen Patterson3, Linda-Gail Bekker6, Suwat Chariyalertsak7, Anupong Chitwarakorn8, Pedro Gonzales9, Timothy H Holtz10,11, Kenneth H Mayer12, Carmen Zorrilla13, Susan Buchbinder1, Jeanna M Piper14, Javier R Lama15, Ross D Cranston16. 1. Bridge HIV, San Francisco Department of Public Health, San Francisco, CA. 2. Departments of Population Health and Internal Medicine, University of Texas at Austin, Austin, TX. 3. Statistical Center for HIV/AIDS Research and Prevention/Fred Hutchinson Cancer Research Center, Seattle, WA. 4. Department of Psychiatry, New York State Psychiatric Institute and Columbia University, New York City, NY. 5. FHI 360, Durham, NC. 6. Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa. 7. Department of Community Medicine, Research Institute for Health Sciences (RIHES), Chiang Mai University, Chiang Mai, Thailand. 8. Thailand Ministry of Public Health, Nonthaburi, Thailand. 9. Asociacion Civil Impacta Salud y Educacion, San Miguel, Peru. 10. Thailand Ministry of Public Health-US CDC Collaboration, Nonthaburi, Thailand. 11. Department of HIV/AIDS Prevention, CDC, Atlanta, GA. 12. Fenway Health, The Fenway Institute, Boston, MA. 13. Department of Obstetrics and Gynecology, CEMI/UPR-CTU, University of Puerto Rico, San Juan, Puerto Rico. 14. National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. 15. IMPACTA PERU Clinical Trials Unit, Asociacion Civil Impacta Salud y Educacion, Lima, Peru. 16. Department of Medicine, University of Pittsburgh, Pittsburgh, PA.
Abstract
BACKGROUND: 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.
BACKGROUND: 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-uninfectedmen 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.
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