Oware, Kevin
Adiema, Lydia
Rono, Bernard
Violette, Lauren R.
McClelland, R. Scott
Donnell, Deborah
Scoville, Caitlin W.
Odoyo, Josephine
Baeten, Jared M.
Bukusi, Elizabeth
Stewart, Jenell
Article History
Received: 3 September 2022
Accepted: 5 May 2023
First Online: 3 June 2023
Declarations
:
: Dr. McClelland has received honoraria for consulting for Lupin Pharmaceuticals and research funding, paid to the University of Washington, from Hologic Corporation. Dr. Baeten is an employee of Gilead Sciences outside of the submitted work. The author and all other co-authors do not have any declared conflict of interest.
: Ethics approval was received from all pertinent approving bodies in Kenya and the USA: University of Washington’s Institutional Review Board (UW IRB STUDY00007487), Kenya Medical Research Institute Scientific Ethics Review Unit (KEMRI SERU P00122/3915), and Pharmacy and Poisons Board (PPB ECCT 19/11/02/2020(013). Written informed consent to participate in the study was obtained from all participants and legal guardians of the illiterate participants before enrolment. All methods were carried out in accordance with relevant guidelines and regulations of the Kenyan Ministry of Health.
: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results.