The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Protocol for School-Age Follow-up
Authors: Piper Joe D , Mazhanga Clever , Mwapaura Marian , Mapako Gloria , Mapurisa Idah , Mashedze Tsitsi , Munyama Eunice , Kuona Maria , Mashiri Thombizodwa , Sibanda Kundai , Matemavi Dzidzai , Tichagwa Monica , Nyoni Soneni , Saidi Asinje , Mangwende Manasa , Chidhanguro Dzivaidzo , Mpofu Eddington , Tome Joice , Mutasa Batsirai , Chasekwa Bernard , Smuk Melanie , Smith Laura E , Njovo Handrea , Nyachowe Chandiwana , Muchekeza Mary , Mutasa Kuda , Sauramba Virginia , Langhaug Lisa F , Tavengwa Naume V , Gladstone Melissa J , Wells Jonathan C , Allen Elizabeth , Humphrey Jean H , Ntozini Robert , Prendergast Andrew J ,   the SHINE Follow-up Study Team
Published: August 2022

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 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 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.