Content area
Full text
About the Authors:
Urvi M. Parikh
* E-mail: [email protected]
Affiliation: Department of Infectious Diseases, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States of America
Photini Kiepiela
Affiliation: HIV Prevention Research Unit, Medical Research Council, Durban, South Africa
Shayhana Ganesh
Affiliation: HIV Prevention Research Unit, Medical Research Council, Durban, South Africa
Kailazarid Gomez
Affiliation: FHI 360, Research Triangle Park, North Carolina, United States of America
Stephanie Horn
Affiliation: FHI 360, Research Triangle Park, North Carolina, United States of America
Krista Eskay
Affiliation: Department of Infectious Diseases, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States of America
Cliff Kelly
Affiliation: Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America
Barbara Mensch
Affiliation: Population Council, New York, New York, United States of America
Pamina Gorbach
Affiliation: Department of Epidemiology, University of California Los Angeles, Los Angeles, California, 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
Gita Ramjee
Affiliation: HIV Prevention Research Unit, Medical Research Council, Durban, South Africa
John W. Mellors
Affiliation: Department of Infectious Diseases, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States of America
on behalf of the IPTc Taskforce
¶Membership of the MTN-009 Protocol Team is provided in the Acknowledgments
Introduction
Women are disproportionately burdened by human immunodeficiency virus (HIV) infection, particularly in sub-Saharan Africa, where approximately three-quarters of new HIV-1 infections are in young women aged 15–24 years [1], [2]. Recent clinical trials evaluating tenofovir as a potential chemo-preventative agent have screened thousands of women for participation in large-scale studies including FEM-PrEP, CAPRISA-004, TDF2 and MTN-003 (VOICE) [3]. Inevitably, some women who present to the clinic intending to participate in an HIV-prevention trial discover they are HIV positive or already have knowledge of their status but still seek HIV prevention products or trial participation for other reasons [4]. This group of women is critical to understand both from a virologic and behavioral perspective because the future success and large scale implementation of an ARV product for HIV prevention largely depends on targeting the appropriate population for its use.
One of the major concerns of using ARV-based products for HIV prevention...