Community health promotion and medical provision and impact on neonates (CHAMPION2) and support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2): an update to the study protocol (v 11) for a cluster randomised trial in Madhya Pradesh, India

• Published in: Current controlled trials in cardiovascular medicine Vol. 25; no. 1; pp. 462 - 8
• Main Authors: Shivalli, Siddharudha, Fazzio, Ila, Frost, Chris, Elbourne, Diana, Magill, Nicholas, Sharma, Dropti, Shekhawat, Sajjan Singh, Banerji, Rukmini, Karnati, Sridevi, Reddy, Harshavardhan, Reddy, Padmanabh, Nair, Rakhi, Gopal, Madan, Boone, Peter
• Format: Journal Article
• Language: English
• Published: England BioMed Central 08-07-2024; BMC
• Subjects: Caregivers; Children & youth; Cluster randomised controlled trial; Community; Consent; COVID-19; COVID-19 - epidemiology; COVID-19 - prevention & control; Data collection; Disease transmission; Education; Female; Health Literacy; Health Promotion - methods; Health services; Humans; Immediate neonatal care; India; Infant, Newborn; Literacy; Maternal mortality; Meetings; Mothers; Neonatal mortality; Newborn babies; Pandemics; Postnatal care; Pregnancy; Randomized Controlled Trials as Topic; Rural Population; SARS-CoV-2; Towns; Update; Womens health; India; Madhya Pradesh India; Primary education; Maternal mortality; Immediate neonatal care; Neonatal mortality; Cluster randomised controlled trial; Supplementary teaching; Stillbirths; Literacy; Numeracy; Postnatal care; India
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08245-z

This update outlines amendments to the CHAMPION2/STRIPES2 cluster randomised trial protocol primarily made due to the COVID-19 pandemic and nationwide lockdown in India in 2020. These amendments were in line with national guidelines for health research during the COVID-19 pandemic.
We did not change the original trial design, eligibility, and outcomes. Amendments were introduced to minimise the risk of COVID-19 transmission and ensure safety and wellbeing of trial staff, participants, and other villagers. CHAMPION2 intervention: participatory learning and action (PLA) and fixed day service (FDS) meeting were revised to incorporate social distancing and hygiene precautions. During the COVID-19 pandemic, PLA participation was limited to pregnant women and birthing partners. STRIPES2 intervention: before/after-school classes were halted for a period and then modified temporarily (reducing class sizes, and/or changing meeting places) with hygiene and safe distancing practices introduced.
The research team gathered as much information as possible from participants by telephone. If the participant had no telephone or could not be contacted by telephone, data were collected in person. COVID-19 precautions: trial teams were trained on COVID-19 precautions and used personal protective equipment whilst in the villages for trial-related activities. After restarting the trial between June and September 2020 in a phased manner, some trial activities were suspended again in all the trial villages from April to June 2021 due to the second wave of COVID-19 cases and lockdown imposed in Satna, Madhya Pradesh. Trial timelines were also revised, with outcomes measured later than originally planned.
Clinical Trial Registry of India CTRI/2019/05/019296. Registered 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2 .