Document is current

Article History

Received: 21 May 2025

Accepted: 26 May 2025

First Online: 30 July 2025

Declarations

:

: The study is approved by the ethics committees of Harvard Medical School (IRB20-2144, v11), Sangath (AB-2021–69, v1.7), and AIIMS Bhopal (EF0237). Additional approval, as required for all foreign-funded research in India, was obtained from the Government of India's Health Ministry Screening Committee, housed at the Indian Council of Medical Research. Amendments to the protocol are agreed upon by the TSC and approved by relevant IRBs prior to implementation. The consent process, conducted by trained and supervised Research Assistants, includes three stages: consent for the screening/eligibility survey, consent for main study enrollment for eligible participants, and a separate consent for blood or saliva sample collection. To standardize the process and ensure consistent delivery of key information, a video was developed to guide participants through the consent procedures. Written informed consent at each stage is mandatory for enrolling in the trial. While study participants do not receive direct payment for their participation, they receive 500 INR as reimbursement for the opportunity cost for each of the seven scheduled study assessments (baseline, week 1.5, week 6, week 12, month 6, month 9, and month 12), totaling 3,500 INR, approximately USD 40).

: Not applicable.

: The authors declare no competing interests.