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Article History

Received: 3 May 2021

Accepted: 10 December 2021

First Online: 15 January 2022

Declarations

:

: This study protocol was reviewed and approved by the Institutional Review Board (IRB) of Emory University (IRB00115339) in Georgia, USA and the Independent Ethics Committee at Xavier University, Bhubaneswar (220519) in Odisha, India. Protocol modifications that arise during the course of the study are reviewed and approved by the IRB of Emory University. Material modifications will also be reviewed and approved by Xavier University Bhubaneswar, if required, and will also be noted in publications and updated in the trial registration. All study participants are consented prior to engagement in a research activity. A trained research assistant reads the consent form in Odia, the local language, to the potential participant. The consent form provides information about the purpose of the research activity, anticipated time commitment, and anticipated risks and benefits. The research assistant then asks for the individual’s voluntary participation through verbal consent. All research activities engage adults aged 18 years or older, except for the environmental sampling which also engages children < 5 years old. The caregiver of the child will be asked to give their verbal consent on behalf of the child for collecting a hand rinse sample from the child. Verbal consent is used instead of written consent due to low literacy rates in the study area, especially among women. Many of the primary caregivers engaged in the study may have felt vulnerable signing a form they could not read. All consent forms are available upon request. Only research team members will have access to identifying information, including participant names.

: Not applicable.

: The authors declare that they have no competing interests.