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Article History

Received: 30 June 2020

Accepted: 9 November 2020

First Online: 26 November 2020

Ethics approval and consent to participate

: The pilot and main trial methods for the India site activities of HAPIN trial were approved by the Institutional Ethics Committee at Sri Ramachandra Institute of Higher Education and Research (IEC-N1/16/JUL/54/49), Emory University Institutional Review Board (00089799) and the Indian Council of Medical Research–Health Ministry Screening Committee (5/8/4–30/(Env)/Indo-US/2016-NCD-I).HAPIN is registered atunder identifier NCT02944682. Written informed consents as approved by the Ethics Committees were obtained from all study participants prior to any data collection. The field team was provided extensive training in administering the informed consent in local language (Tamil). Further, team worked closely with the village health nurses (VHNs) to access the participant households. The consent was administered in the household in the presence of other members of the family and the VHN (whenever feasible). In the event the VHN could not accompany the field team, the household received a briefing from the VHN, prior to the visit by the field team. This allowed the participant to raise any concerns directly with the VHN as well as the opportunity to consult other family members, prior to providing consent. Finally, since the form was written and administered in local language, despite the low mean number of school years, participants did not find it difficult to provide a written consent. A thumb impression was obtained for participants who could not write along with the signature of a witness.

: A duly signed informed consent was obtained from individual subjects for photographs and for publication of participant image. Consents can be furnished upon request.

: The authors declare that they have no competing interests.