The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Protocol for School-Age Follow-up

Abstract

ABSTRACTBackgroundThere is a need for follow-up of early-life stunting intervention trials into childhood to determine their long-term impact. A holistic school-age assessment of health, growth, physical and cognitive function will help to comprehensively characterise the sustained effects of early-life interventions.MethodsThe Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe assessed the effects of improved infant and young child feeding (IYCF) and/or improved water, sanitation and hygiene (WASH) on stunting and anaemia at 18 months. Among children enrolled to SHINE, 1300 are undergoing follow-up at 7-8 years of age (1000 HIV-unexposed and 300 HIV-exposed children). Children are assessed using the School-Age Health, Activity, Resilience, Anthropometry and Neurocognitive (SAHARAN) toolbox, which provides a holistic measurement of growth, body composition, cognitive and physical function. In parallel, a detailed caregiver questionnaire assesses household demographics, socioeconomic status, adversity, nurturing, caregiver support, food and water insecurity. A monthly morbidity questionnaire is administered by community health workers to evaluate school-age rates of infection and healthcare-seeking. The impact of the SHINE IYCF and WASH interventions, the early-life ‘exposome’, maternal HIV, and contemporary exposures on each school-age outcome will be assessed. We will also undertake an exploratory factor analysis to generate new, simpler metrics for assessment of cognition (COG-SAHARAN), growth (GROW-SAHARAN) and combined growth, cognitive and physical function (SUB-SAHARAN). The SUB-SAHARAN toolbox will be used to conduct annual assessments within the SHINE cohort from ages 8-12 years.Ethics and disseminationThe study has been approved by the Medical Research Council of Zimbabwe (dated 8th February 2021) and registered with Pan-African Clinical Trials Registry (PACTR202201828512110). Primary caregivers provide written informed consent and children written assent. Findings will be disseminated to the community at sensitisation events, through conference presentations, peer-reviewed journals and key stakeholders including the Zimbabwean Ministry of Health and Child Care, and UNICEF.Article SummaryThis protocol describes the follow-up of school-age children after receiving early-life IYCF and WASH interventions in rural Zimbabwe.A comprehensive measurement of the child’s health, growth, body composition, physical and cognitive function will be performed.Analysis of the ‘exposome’, including maternal HIV status, will identify the early-life factors that shape school-age physical and cognitive functionCapitalizing on the randomized trial design will allow the long-term effects of IYCF and WASH on child health outcomes to be estimated.Limitations include the re-enrolment of only a subgroup of children from one of the two original study districts; exclusion of HIV-positive children; and the long period between early-life randomized interventions and school-age outcome assessment.