Wexler, Catherine
Maloba, May
Sliefert, Michala
Babu, Shadrack
Maosa, Nicodemus
Maliski, Edward
Nicolay, Zachary
Were, Frederick
Mbithi, Yvonne
Mugendi, George
Thomas, Gregory
Acharya, Harshdeep
Finocchario-Kessler, Sarah
Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (R21HD105534)
Article History
Received: 20 February 2023
Accepted: 27 September 2023
First Online: 16 October 2023
Declarations
:
: All study procedures were approved by Institutional Review Boards at the University of Kansas Medical Center (STUDY00147024) and the University of Nairobi Ethics and Review Committee (P457/06/2021). All methods were carried out in accordance with relevant guidelines and regulations. All participants completed a written informed consent prior to participating in the study. The informed consent process was designed to appropriately inform both literate and illiterate participants about the study, including the purpose and potential benefits and risks. A Mentor Mother or study team member walked each client through the informed consent document. Prior to a request for written informed consent, participants were asked to summarize what they’ve been told/read to ensure comprehension and were given the opportunity to ask questions. Participants who were non-literate were given the option of using a thumb-print in lieu of a signature for study consent. These informed consent procedures were approved by the Institutional Review Boards at the University of Kansas Medical Center and the University of Nairobi.
: N/A.
: Dr. Edward Maliski is the majority owner of Oak Therapeutics and co-inventor of US Patent Application16/630,638 (Pat. Pend.) All other authors declare they have no conflicts of interest.