Wairimu, Njeri
Malen, Rachel C.
Reedy, Adriana M.
Mogere, Peter
Njeru, Irene
Culquichicón, Carlos
McGowan, Maureen
Gao, Fei
Baeten, Jared M.
Ngure, Kenneth
Ortblad, Katrina F. http://orcid.org/0000-0002-5675-8836
Funding for this research was provided by:
National Institute of Mental Health (R00 MH121166)
Article History
Received: 20 July 2023
Accepted: 16 October 2023
First Online: 4 November 2023
Declarations
:
: The trial protocol (version 1.10, October 2023), informed consent forms, and participant education and recruitment materials have all been approved by the Scientific Ethics Review Unit at the Kenya Medical Research Institute (Nairobi, Kenya) and the Institutional Review Board at the Fred Hutchinson Cancer Center (Seattle, United States). All participants will provide written informed consent (available in English and Kiswahili); peer providers prior to enrollment and randomization, and peer clients prior to their month 3 follow-up visit. Peer clients will have the option for either written or verbal consent (using a consent script) based on whether they complete their follow-up visit in person at the PHRD research site or remotely over the phone. All consent forms include an option to opt-out of future sharing of identifiable data; the peer client consent form included an option to opt-out of DBS collection for PrEP adherence testing. At any point during study implementation, participants may discontinue participation. Any potential protocol modifications will be reviewed by our ethics boards before implementation and, if necessary, participants notified of these changes and the Clinicaltrials.gov trial registry will be updated.
: Not applicable.
: JMB is a current employee of Gilead Sciences, outside of the present work. KN has received research funding from the Merck Investigator Program. All other authors declare no competing interests.