Magill, Nicholas http://orcid.org/0000-0002-5138-3166
Shivalli, Siddharudha
Fazzio, Ila
Elbourne, Diana
Keddie, Suzanne
Reddy, Padmanabh
Nair, Rakhi
Gopal, Madan
Karnati, Sridevi
Reddy, Harshavardhan
Boone, Peter
Frost, Chris
Funding for this research was provided by:
Medical Research Council (MR/N013638/1)
Article History
Received: 5 January 2024
Accepted: 11 March 2024
First Online: 25 April 2024
Declarations
:
: The Ethics Committees of L V PRASAD Eye Institute, Hyderabad, India (LEC 02–16–008) and London School of Hygiene and Tropical Medicine (LSHTM Ethics Ref: 10482) have approved the trial protocol. We have obtained the necessary approvals from the Indian Council of Medical Research, New Delhi, and the Government of Madhya Pradesh to conduct this trial in Satna district. At the state level, approval of the protocol was obtained from the Department of Health & Family Welfare of the government of Madhya Pradesh. The trial complies with the Declaration of Helsinki, local laws, and the International Conference on Harmonisation Good Clinical Practice (ICH-GCP). All protocol modifications were communicated to both ethics committees.This trial employs multiple tiers of consent: village and individual. Agreement to approach eligible villages was first obtained from the Sarpanch. In the trial villages, consent was obtained from the village after the trial had been presented in a meeting with village elders representing all the castes and village residents. Verbal consent was given during a village meeting with written documentation (or thumbprint) of the approval given by the Sarpanch. This process of obtaining consent through meetings with approval of the “guardians” of the clusters is common in trials in which the intervention is delivered at the level of a cluster and it is not possible to obtain informed consent for randomisation from individuals within the cluster before a baseline survey.Once the trial was accepted at the village meeting, the villages were considered eligible for baseline enumeration. During the process of baseline interview, each head of household and each potentially eligible woman and unmarried man was informed in the local language (Hindi) about the trial and their participation and asked for a signature or thumbprint to indicate their consent to join the trial. Only people who agreed to participate were enumerated. People have the right to withdraw consent at any time during the trial. This process of consent is compatible with current standards for cluster randomised trials [].
: Participants (household heads, women, unmarried men) were informed that we would revisit the households to interview them about pregnancies, babies, and marriages so we could understand the impact of the CHAMPION2 and STRIPES2 programmes. All participants agreed that all individual information collected during interviews will be used only for research purposes and in ways that will not reveal their identity.
: PB is the executive chair of EI; IF is a paid employee of EI but has no competing interests. DE and CF received research grant funding from EI but have no competing interests. NM, SS, and SKe are employed in these research grants but have no competing interests. SKa and HR receive research funding from EI but have no competing interests. PR, RN, and MG receive research funding from EI but have no competing interests.