Study concept and design: Mugo, Celum, Donnell, Baeten.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Mugo, Hong, Baeten.
Critical revision of the manuscript for important intellectual content: Mugo, Celum, Donnell, Bukusi, Wangisi, Were, Heffron, Matthews, Morrison, Baeten.
Statistical analysis: Mugo, Hong, Donnell, Heffron, Baeten.
Obtained funding: Celum, Baeten.
Administrative, technical, or material support: Bukusi, Wangisi, Were, Ngure, Baeten.
Study supervision: Celum, Donnell, Bukusi, John-Stewart, Wangisi, Were, Baeten.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr John-Stewart reports receiving personal fees from UpToDate and grants from Firland for activities outside the submitted work. Dr Wangisi reports that his institution received grants and support for travel or meetings from TASO U Ltd. Dr Baeten reports receiving nonfinancial support in the form of donated study product from Gilead Sciences. No other authors reported disclosures.
Funding/Support: The Partners PrEP Study was funded by The Bill and Melinda Gates Foundation (grant OPP47674). Study medication was donated by Gilead Sciences (Foster City).
Role of the Sponsors: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Partners PrEP Study Team: University of Washington Coordinating Center and Central Laboratories: Connie Celum (principal investigator, protocol cochair), Jared M. Baeten (medical director, protocol cochair), Deborah Donnell (protocol statistician), Robert W. Coombs, Lisa Frenkel, Craig W. Hendrix, Jairam Lingappa, M. Juliana McElrath.
Study sites and site principal investigators: Eldoret, Kenya (Moi University, Indiana University): Kenneth Fife, Edwin Were; Kabwohe, Uganda (Kabwohe Clinical Research Center): Elioda Tumwesigye; Jinja, Uganda (Makerere University, University of Washington): Patrick Ndase, Elly Katabira; Kampala, Uganda (Makerere University): Elly Katabira, Allan Ronald; Kisumu, Kenya (Kenya Medical Research Institute, University of California, San Francisco): Elizabeth Bukusi, Craig Cohen; Mbale, Uganda (The AIDS Support Organization, CDC-Uganda): Jonathan Wangisi, James Campbell, Jordan Tappero; Nairobi, Kenya (University of Nairobi, University of Washington): James Kiarie, Carey Farquhar, Grace John-Stewart; Thika, Kenya (University of Nairobi, University of Washington): Nelly Rwamba Mugo; Tororo, Uganda (CDC-Uganda, The AIDS Support Organization): James Campbell, Jordan Tappero, Jonathan Wangisi.
Data management was provided by DF/Net Research, Inc (Seattle) and site laboratory oversight was provided by Contract Laboratory Services (University of the Witwatersrand, Johannesburg, South Africa).
Additional Contributions: We thank the site teams, particularly the site clinicians who conducted the assessments of women and their infants for this analysis, and the couples who participated in this study. The study team acknowledges the Director KEMRI for support. Study medication was donated by Gilead Sciences (Foster City).