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Article History

Received: 17 April 2023

Accepted: 12 June 2023

First Online: 22 July 2023

Declarations

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: 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. The trial complies with the Declaration of Helsinki, local laws, and the International Conference on Harmonisation Good Clinical Practice (ICH-GCP). Any protocol modifications will be communicated to both the Ethics Committees, and consent will be re-obtained at the village and individual (woman or caregiver) level at that point if deemed necessary.For this trial, we received approval from the Indian Medical Council of Research (ICMR), New Delhi, India. At the state level, approval of the protocol was obtained from the Department of Health & Family Welfare of the government of Madhya Pradesh.This trial employs multiple tiers of consent: village, individual, and individual on behalf of the child. Agreement to approach eligible villages was first obtained from the <i>Sarpanch</i>. In the trial villages, consent was obtained from the village after the trial has 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 <i>Sarpanch</i>. 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, each potentially eligible woman and one parent or caregiver of each potentially eligible child 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. Women and caregivers of enumerated children 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, and caregivers on behalf of children) were informed that we would revisit the households to interview them about pregnancies, babies, and children’s school enrolment so we could understand to 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 grants funding from EI but have no competing interests. SKe, NM and SiS are employed in these research grants but have no competing interests. SKa and HR receive research funding from EI but have no competing interests. RB, DS, and SSh declare a potential competing interest due to the involvement of Pratham Education Foundation (an independent organisation), which currently works to improve the quality of education in India. AE has no competing interests.