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

ABSTRACT Background There 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. Methods The 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 dissemination The study has been approved by the Medical Research Council of Zimbabwe (dated 8 th 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 Summary This 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 function Capitalizing 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.