Shivalli, Siddharudha
Fazzio, Ila
Elbourne, Diana
Karnati, Sridevi
Reddy, Harshavardhan
Reddy, Padmanabh
Nair, Rakhi
Gopal, Madan
Boone, Peter
Frost, Chris
Funding for this research was provided by:
Effective Intervention, UK
Article History
Received: 6 October 2024
Accepted: 5 March 2026
First Online: 23 March 2026
Declarations
:
: The ethics committees of L V PRASAD Eye Institute, Hyderabad, India (LEC 02-16-008) and the London School of Hygiene and Tropical Medicine (LSHTM Ethics Ref: 10482) have approved this study as a part of the CHAMPION2/STRIPES2 cluster randomized trial protocol. We have obtained the necessary approvals from Indian Council of Medical Research (ICMR), New Delhi, and from the Department of Health & Family Welfare of the government of Madhya Pradesh. The study complies with the Declaration of Helsinki, local laws, and the International Conference on Harmonization Good Clinical Practice (ICH-GCP). We obtained written informed consent (signature or thumbprint) from all the women participants for their voluntary participation.
: Not Applicable.
: PB is the Executive Chair of EI; IF is a paid employee of EI but has no competing interests. DE and CF received research grants funding from EI but have no competing interests. SS is employed on this research grant but has no competing interests. SK and HR receive research funding from EI but have no competing interests. PR, RN, and MG declare a potential competing interest due to the involvement of the NICE Foundation (an independent organization) which is involved in programs intervening with women and children in rural and urban Telangana (previously Andhra Pradesh) and Rajasthan.