Nyongesa, Moses K.
Mwatasa, Mwaganyuma H.
Kagonya, Vincent A.
Mwambingu, Gabriel
Ngetsa, Caroline
Newton, Charles R. J. C.
Abubakar, Amina
Funding for this research was provided by:
Wellcome Trust (201310/Z/16/Z)
Medical Research Council (MR/M025454/1)
Article History
Received: 17 September 2021
Accepted: 28 April 2022
First Online: 11 May 2022
Declarations
:
: This study was conducted in accordance with the ethical principles and guidelines for involving humans as participants as outlined in the Declaration of Helsinki. The local institutional review board, Scientific and Ethics Research unit (SERU) of the Kenya Medical Research Institute (KEMRI) approved the study (Ref KEMRI/SERU/CGMR-C/108/3594). Permission to work in the HIV clinics of the two Counties was granted by the research office, department of health in Kilifi (Ref: HP/KCHS/VOL.IX/44) and Mombasa (Ref: COH/Msa/RSC/05). Participation in the study was voluntary and all participants provided written informed consent for their participation, including consent for collection of blood samples. For illiterate participants, an available witness at the time and chosen by the participant (such as another literate client or a health care provider at the clinic) was involved during the consenting process. These participants were taken through the study information sheet separately by our field team member and the appointed witness, after which they were asked to explain what they understood. Once the field team member and the participant witness were independently satisfied that the participant had understood the contents of the information sheet, the witness filled the consent form on behalf of the participant then the participant placed a thumb-print in the respective area of the form, a proof of consent. The witness also appended their name and signature on the consent form. This process was approved by the ethics board named above. We confirm that all the illiterate participants thumb-printed an informed consent form before being enrolled in the study.
: Not applicable.
: None of the authors has any potential conflict of interest to declare.