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Article History

Received: 28 September 2021

Accepted: 15 October 2021

First Online: 11 December 2021

Declarations

:

: The protocol described herein was approved as a minimal risk study by the Ethical Research Committee of the Kenyatta National Referral Hospital and the Human Subjects Division of the University of Washington. As is the case for all routine services, oral consenting for routine services (i.e., all procedures key for provision of PrEP as part of standard of care, HIV testing, and PrEP provision) will be done by the existing FP healthcare providers. Persons who participate in all planned research related procedures (procedures not directly related to standard of care provision of PrEP services e.g., qualitative interviews, questionnaires, blood draw for drug levels, participation in observational cohort, archiving of specimens for STI testing), written informed consent will be obtained before any procedures are conducted. Consenting for research procedures will be conducted by the research team. The research team meets weekly for executive as well as safety and quality management purposes. The project is subject to oversight by an independent external data monitoring committee (DMC) established to oversee project implementation, data quality, monitor implementation and clinical outcomes, and patient safety. The committee consists of expert clinicians, statisticians, policymakers and stakeholders from the HIV and SRH space in Kenya settings. The committee meets 6-monthly to advise on study progress and whether the work aligns with Kenya MOH policies, and to offer guidance about results from international studies of PrEP that may spur policy change in Kenya. The DMC will review data on HIV testing and counseling, HIV infection, FP service use, PrEP uptake, continue and adherence, adverse outcomes, implementation outcomes, and will provide recommendations to the project implementation team as part of six-monthly reviews. Review follow will follow an unblinded fashion, consistent with the open label, unblinded nature of the implementation project. No interim analyses are planned for this open-label implementation project.

: Not applicable

: All authors declare no competing interests