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Article History

Received: 27 March 2023

Accepted: 17 July 2023

First Online: 27 July 2023

Declarations

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: Ethical approval for the protocol was obtained from the Institutional Review Boards (IRBs) or Ethics Commissions of BRAC University (Board Approval Number: IRB-28 October'21–036 BRAC James P Grant School of Public Health (JPGSPH)) and Stanford University School of Medicine (Protocol: 63070) prior to the start of participant recruitment, data collection or the implementation of any trial interventions.Fieldworkers will provide all potential participants in the study with a consent form to read. The document will contain multiple diagrams and illustrations to explain the key concepts of the project. For illiterate participants, the fieldworkers will read the information sheet in the native spoken language of the participants, as necessary. The information sheet will outline the scope, purpose and procedures of the study as well as the risks and benefits of study participation. The fieldworkers will answer any questions before asking for consent. If the potential participant meets the inclusion and exclusion criteria and wishes to participate, she or he will be asked to sign or thumbprint the consent form; the fieldworker will then countersign. If the participant is illiterate, a witness will sign in addition to the participant’s fingerprint. One signed consent form will remain with the participant; a second signed consent form will be retained by the study team. All study subjects will be informed that they may withdraw consent to participate in the trial at any point during the study. If information is to be withheld from a participant, our data collectors will explain the importance of such procedures to the research. If the participant is not convinced, she or he can withdraw at any point of time during the interview. The research methods and data collection process do not pose any potential risks to the participants. They will also be informed that there will not be any discrimination against participants who refuse to participate or leave the study at any point of time. The respondents will be informed that they will receive a face mask and some hand soap but no financial incentives or compensations will be provided for their time.

: A model consent form is provided as Supplementary Material .

: The principal investigators for the overall trial and each study site and coauthors report no financial and other competing interests.