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Article History

Received: 3 August 2018

Accepted: 15 August 2018

First Online: 4 September 2018

Ethics approval and consent to participate

: The protocol described herein was approved as a minimal risk study by the Scientific and Ethics Review Unit of the Kenya Medical Research Institute and the Human Subjects Division of the University of Washington. The research team meets weekly to study for executive as well as safety and quality management purposes. The project is subject to oversight by an independent data monitoring committee that periodically reviews data from the study, including project execution, adherence, HIV incidence, and serious adverse events. Review follows an unblinded fashion, consistent with the open-label, unblinded nature of the implementation project. Persons who participate in the planned qualitative interviews and the random blood draws provide written consent.

: Not applicable

: The authors declare that they have no competing interests.

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