Ochieng, Caroline A.
Haghparast-Bidgoli, Hassan
Batura, Neha
Odhiambo, Aloyce
Shannon, Geordan
Copas, Andrew
Palmer, Tom
Dickin, Sarah
Noel, Stacey
Fielding, Matthew
Onyango, Sangoro
Odera, Sarah
Eleveld, Alie
Mwaki, Alex
Vanhuyse, Fedra
Skordis, Jolene
Funding for this research was provided by:
Bill and Melinda Gates Foundation (OPP1142564)
Article History
Received: 19 March 2018
Accepted: 28 January 2019
First Online: 1 March 2019
Ethics approval and consent to participate
: The study has received ethics approval from the Maseno University Ethics Review Committee, REF MSU/DRPI/MUERC/00294/16. The trial has been registered with ExternalRef removed, registration number NCT03021070.Prior to enrolment into the study, participants are given information about the study (see Additional file InternalRef removed: Participant information sheet) by the enrolling facility staff. The information is shared verbally in the participant’s local language (Dholuo and Swahili), and augmented by an animated video produced for the study that is shown to eligible participants when they visit the clinic. All potential participants are informed that their participation in the study is voluntary, and that even after enrolment they can elect to withdraw from the study at any time they choose Participants are also informed that their choice to participate or not participate in the study would not affect their access to health services or treatment, and that there is no penalty for not participating in the study. Those who agree to participate sign the informed consent form (see Additional file InternalRef removed: Informed consent forms). Study participants are given a take-home information sheet in the form of a calendar. The calendar contains contact information of the research team who they can call if they have any follow-up questions.
: Not applicable.
: The authors declare that they have no competing interests.
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