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Brief Report

Routine Use of Oral PrEP in a Phase 2 Rectal Microbicide Study of Tenofovir Reduced-Glycerin 1% Gel (MTN-017)

Liu, Albert Y. MD, MPHa; Norwood, Aliza MDa,b; Gundacker, Holly MSc; Carballo-Diéguez, Alex PhDd; Johnson, Sherri MPHe; Patterson, Karen MPHc; Bekker, Linda-Gail MBChB, DTMH, DCH, FCP, PhDf; Chariyalertsak, Suwat MD, DrPHg; Chitwarakorn, Anupong MDh; Gonzales, Pedro MDi; Holtz, Timothy H. MD, MPHj,k; Mayer, Kenneth H. MDl; Zorrilla, Carmen MDm; Buchbinder, Susan MDa; Piper, Jeanna M. MDn; Lama, Javier R. MD, MPHo; Cranston, Ross D. MD, FRCPp

JAIDS Journal of Acquired Immune Deficiency Syndromes: August 15, 2019 - Volume 81 - Issue 5 - p 516–520
doi: 10.1097/QAI.0000000000002066
Prevention Research

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.

aBridge HIV, San Francisco Department of Public Health, San Francisco, CA;

bDepartments of Population Health and Internal Medicine, University of Texas at Austin, Austin, TX;

cStatistical Center for HIV/AIDS Research and Prevention/Fred Hutchinson Cancer Research Center, Seattle, WA;

dDepartment of Psychiatry, New York State Psychiatric Institute and Columbia University, New York City, NY;

eFHI 360, Durham, NC;

fDesmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa;

gDepartment of Community Medicine, Research Institute for Health Sciences (RIHES), Chiang Mai University, Chiang Mai, Thailand;

hThailand Ministry of Public Health, Nonthaburi, Thailand;

iAsociacion Civil Impacta Salud y Educacion, San Miguel, Peru;

jThailand Ministry of Public Health—US CDC Collaboration, Nonthaburi, Thailand;

kDepartment of HIV/AIDS Prevention, CDC, Atlanta, GA;

lFenway Health, The Fenway Institute, Boston, MA;

mDepartment of Obstetrics and Gynecology, CEMI/UPR-CTU, University of Puerto Rico, San Juan, Puerto Rico;

nNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD;

oIMPACTA PERU Clinical Trials Unit, Asociacion Civil Impacta Salud y Educacion, Lima, Peru; and

pDepartment of Medicine, University of Pittsburgh, Pittsburgh, PA.

Correspondence to: Albert Y. Liu, MD, MPH, Bridge HIV, San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 100, San Francisco, CA 94102 (e-mail:

Supported by National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the other institutions represented. Gilead Sciences provided FTC/TDF and CONRAD provided RG-TFV.

A.Y.L. and S.B. have received study drug from Gilead Sciences for studies in which they are investigators. K.H.M. has unrestricted research grants from Gilead and Viiv and has been on Scientific Advisory Boards for Gilead and Merck. R.D.C. has received royalties from Uptodate and institutional research funding from ABIVAX pharmaceuticals. The remaining authors have no conflicts of interest to disclose.

Received August 04, 2018

Accepted December 27, 2018

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