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Article History

Received: 9 January 2018

Accepted: 10 October 2018

First Online: 30 October 2018

Ethics approval and consent to participate

: The study will be conducted according to the Declaration of Helsinki, local regulatory requirements, and Protection of Human Subjects (45 CFR 46). The protocol has been reviewed and approved by the Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) of the following organizations:The investigator will regularly inform the IRBs/IEC as to the progress of the study, at a minimum once a year. No changes to the study protocol can be made without prior approval by all IRBs.Informed consent will be obtained from each participant before enrollment in the study. The Informed Consent Form (ICF) will be written in English and translated into Kiswahili and Luo so that participants can consent for participation in the study in the language in which they are comfortable and able to comprehend. The investigator or designee will ask the interested participants to consent to study enrollment with an ICF that explains all pertinent aspects of the study. The investigator or designee will ensure that before the volunteer decides to participate in the study, she understands its purpose, the procedure, and any risks or benefits associated with the study. The participant will be given ample time to read the ICF and have a chance to ask questions about the study. Participants must understand that taking part in the study is their choice. A participant may decide not to take part in the study or stop being in the study at any time without consequence to their medical care at the time of study withdrawal or subsequently. A copy of the signed ICF(s) will be offered to the participant. The consenting process will be conducted in a private room. No study procedures will occur before the participant giving informed consent.Consistent with the Common Federal Policy for the Protection of Human Subjects, if an individual cannot give his or her own consent to participate in a research study, then he or she is ineligible for the study. For participants with low literacy, a member of the study staff will read the ICF to the participant and will ask the participant to document their consent by applying a thumbprint or their mark in the presence of an independent witness. The independent witness must be present for the entire informed consent process for participants with low literacy. We recognize that the presence of a witness during the consenting process could be a possible breach of confidentiality. The witness’ role is to ensure that the participant with low literacy is participating in the study voluntarily and to witness the participant signing or applying a thumbprint or their mark on the consent form. The witness will be either an adult, literate individual of the participant’s choice or a member of staff not directly involved in this protocol who will abide by the confidentiality requirement of the site, clinic, or hospital.

: Not applicable.

: The authors declare that they have no competing interests.

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