About the Authors

Sharon L. Achilles

Roles Conceptualization, Investigation, Methodology, Project administration, Resources, Supervision, Visualization, Writing – original draft, Writing – review & editing

sla40@pitt.edu

Current address: Bill & Melinda Gates Foundation, Seattle, Washington, United States of America

Affiliations Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America, Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America

Clifton W. Kelly

Roles Formal analysis, Methodology, Software, Validation, Visualization, Writing – original draft, Writing – review & editing

Affiliation Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America

Craig J. Hoesley

Roles Investigation, Methodology, Resources, Supervision, Writing – review & editing

Affiliation University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, United States of America

Diana L. Blithe

Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing

Affiliation National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America

Jill Brown

Roles Methodology, Supervision, Writing – review & editing

Current address: Uniformed Services University of the Health Sciences, Bethesda, Maryland, United States of America

Affiliation National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America

Barbra A. Richardson

Roles Conceptualization, Formal analysis, Investigation, Methodology, Supervision, Writing – review & editing

Affiliations Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America, Department of Biostatistics, University of Washington, Seattle, Washington, United States of America

Brid Devlin

Roles Resources, Writing – review & editing

Affiliation International Partnership for Microbicides, Silver Spring, Maryland, United States of America

Craig W. Hendrix

Roles Formal analysis, Investigation, Methodology, Validation, Writing – review & editing

Affiliation Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America

Samuel M. Poloyac

Roles Methodology, Validation, Writing – review & editing

Current address: University of Texas at Austin, College of Pharmacy, Austin, Texas, United States of America

Affiliation Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America

Mark A. Marzinke

Roles Formal analysis, Investigation, Methodology, Supervision, Validation, Writing – review & editing

Affiliation Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America

Holly Gundacker

Roles Formal analysis, Methodology, Supervision, Validation, Writing – review & editing

Affiliation Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America

Devika Singh

Roles Investigation, Supervision, Writing – review & editing

Affiliation Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America

Jeanna M. Piper

Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing

Affiliation National Institutes of Allergy and Infectious Disease, NIH, Bethesda, Maryland

Sherri Johnson

Roles Methodology, Project administration, Supervision, Writing – review & editing

Affiliation FHI 360, Durham, North Carolina, United States of America

John Steytler

Roles Resources, Writing – review & editing

Affiliation International Partnership for Microbicides, Silver Spring, Maryland, United States of America

Beatrice A. Chen

Roles Conceptualization, Investigation, Methodology, Project administration, Resources, Supervision, Writing – review & editing

Affiliations Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America, Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America

on behalf of the MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network

Membership of the MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trails Network and the Contraceptive Clinical Trials Network is provided in the Acknowledgments

Competing Interests

The following authors have read the journal’s policy and have competing interests: Sharon L. Achilles has received consulting fees from Mayne Pharma and Merck and has received research funding from The National Institutes of Health, the US Food and Drug Administration, the Pennsylvania Department of Health, Society of Family Planning Research Fund, Estetra SRL (an affiliate company of Mithra Pharmaceuticals), EvoFem, and Merck, all of which were managed by Magee-Womens Research Institute. Barbra A. Richardson has received payment from Gilead Sciences for DSMB membership. Brid Devlin and John Steytler were full-time salaried employees of the International Partnership for Microbicides (IPM), a non-profit company registered in the United States of America, at the time the work was performed. Craig W. Hendrix is an Inventor on patent relating to vaginal microbicides and the founder of a microbicide development company, both unrelated to this study product and both managed by Johns Hopkins University. Beatrice A. Chen has served on a Merck & Co. advisory board and has received research grants from Sebela, Mylan, and Medicines360, all of which were managed by Magee-Womens Research Institute. NIH employees (Diana L. Blithe, Jill Brown, and Jeanna M. Piper) contributed to the study design, manuscript development and the decision to publish as well as providing safety oversight during study conduct but had no role in data collection and analysis. All other authors have declared that no competing interests exist. This does not alter our adherence to PLOS One policies on sharing data and materials.