Corresponding Author: Catherine E. Oldenburg, ScD, MPH, Francis I. Proctor Foundation, University of California, San Francisco, 490 Illinois St, Floor 2, San Francisco, CA 94143 (catherine.oldenburg@ucsf.edu).
Accepted for Publication: June 25, 2021.
Published Online: July 16, 2021. doi:10.1001/jama.2021.11517
Author Contributions: Drs Oldenburg and Arnold had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Oldenburg, Brogdon, Hinterwirth, Lebas, Redd, Lietman, Arnold, Doan.
Acquisition, analysis, or interpretation of data: Oldenburg, Pinsky, Brogdon, Chen, Ruder, Zhong, Nyatigo, Cook, Lebas, Redd, Porco, Arnold, Doan.
Drafting of the manuscript: Oldenburg, Arnold, Doan.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Oldenburg, Nyatigo, Arnold.
Obtained funding: Oldenburg, Lietman, Doan.
Administrative, technical, or material support: Oldenburg, Pinsky, Brogdon, Chen, Ruder, Zhong, Nyatigo, Cook, Hinterwirth, Lebas, Redd, Lietman, Doan.
Supervision: Oldenburg, Lebas, Doan.
Conflict of Interest Disclosures: Ms Cook reported receipt of grants from the National Institutes of Health. Dr Lietman reported receipt of grants from Pfizer Inc, the National Institutes of Health, and the Bill & Melinda Gates Foundation. Dr Arnold reported receipt of grants from the Bill & Melinda Gates Foundation and the National Institute of Allergy and Infectious Diseases and hotel/airfare reimbursement to attend global health meetings from the Bill & Melinda Gates Foundation. No other disclosures were reported.
Funding/Support: This trial was supported by the Bill & Melinda Gates Foundation (grant INV-017026). Azithromycin and matching placebo were donated by Pfizer Inc. Dr Doan was supported in part by a Research to Prevent Blindness Career Development Award.
Role of the Funder/Sponsor: The study sponsors 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; or decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank Chris Damman, MD, and Rebecca Brander, PhD, program officers from the trial’s sponsor, the Bill & Melinda Gates Foundation. We thank Charles Knirsch, MD, Pfizer Inc, for advice on azithromycin dosing. We also thank the members of the DSMC: Art Reingold, MD, University of California, Berkeley; Emily Gower, PhD, University of North Carolina; and David Glidden, PhD, University of California, San Francisco. Drs Reingold, Gower, and Glidden received honoraria for their role in the DSMC. We thank William Hernandez, RN, and Ada Victoria Cevallos, MS, for translation services. Mr Hernandez and Ms Cevallos were compensated for their roles in the study. We thank J. Daniel Kelly, MD, Seth Blumberg, MD, and Ying Lin, MS, for advice and logistical support during the conduct of the trial. These individuals were employees of the University of California, San Francisco, at the time of the study and were paid as part of their employment but did not receive additional compensation for their role in the study. We also thank the study participants.
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