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About the Authors:
Craig W. Hendrix
* E-mail: [email protected]
Affiliation: Department of Medicine, Johns Hopkins University, Baltimore, Maryland, United States of America
Beatrice A. Chen
Affiliation: Center for Family Planning Research and Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America
Vijayanand Guddera
Affiliation: South African Medical Research Council, Durban, South Africa
Craig Hoesley
Affiliation: Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, United States of America
Jessica Justman
Affiliation: ICAP, Mailman School of Public Health, Columbia University, New York, New York, United States of America
Clemensia Nakabiito
Affiliation: MU-JHU Research Collaboration, Kampala, Uganda
Robert Salata
Affiliation: Department of Medicine, Case Western Reserve University, Cleveland, Ohio, United States of America
Lydia Soto-Torres
Affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America
Karen Patterson
Affiliation: Department of Biostatistics, University of Washington, Seattle, Washington, United States of America
Alexandra M. Minnis
Affiliations Women’s Global Health Imperative, RTI International, San Francisco, California, United States of America, School of Public Health, University of California, Berkeley, California, United States of America
Sharavi Gandham
Affiliation: SCHARP, Seattle, Washington, United States of America
Kailazarid Gomez
Affiliation: FHI 360, Research Triangle Park, North Carolina, United States of America
Barbra A. Richardson
Affiliation: Department of Biostatistics, University of Washington, Seattle, Washington, United States of America
Namandje N. Bumpus
Affiliation: Department of Medicine, Johns Hopkins University, Baltimore, Maryland, United States of America
Introduction
Four recently completed clinical trials demonstrated the effectiveness of both vaginal and oral tenofovir (TFV)-containing regimens as pre-exposure prophylaxis (PrEP) to prevent HIV infection in susceptible men, women, and partners of HIV-infected individuals [1], [2], [3], [4]. Relative risk reduction varied widely: 39% in women using vaginal TFV gel before and after sex (CAPRISA 004) [1], 44% in men who have sex with men (MSM) using daily oral TFV disoproxil fumarate (TDF)/emtricitabine (FTC) (iPrEX) [2], 62% or 75% with daily use of TDF/FTC in men and women whose heterosexual partner(s)’ HIV-1 serostatus was either unknown (CDC TDF2) [4] or known positive (Partner’s PrEP) [3], respectively. In contrast, all or part of two other studies of women using daily TDF/FTC tablets (FEM-PrEP) [5], daily TDF tablets (VOICE) [6], or daily TFV vaginal gel (VOICE) [7] were...