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Abstract
Introduction HIV-exposed uninfected children may be at risk of poor neurodevelopment. We aimed to test the impact of improved infant and young child feeding (IYCF) and improved water, sanitation and hygiene (WASH) on early child development (ECD) outcomes.
Methods Sanitation Hygiene Infant Nutrition Efficacy was a cluster randomised 2×2 factorial trial in rural Zimbabwe ClinicalTrials.gov NCT01824940). Pregnant women were eligible if they lived in study clusters allocated to standard-of-care (SOC; 52 clusters); IYCF (20 g small-quantity lipid-based nutrient supplement/day from 6 to 18 months, complementary feeding counselling; 53 clusters); WASH (pit latrine, 2 hand-washing stations, liquid soap, chlorine, play space, hygiene counselling; 53 clusters) or IYCF +WASH (53 clusters). Participants and fieldworkers were not blinded. ECD was assessed at 24 months using the Malawi Developmental Assessment Tool (MDAT; assessing motor, cognitive, language and social skills); MacArthur Bates Communication Development Inventories (assessing vocabulary and grammar); A-not-B test (assessing object permanence) and a self-control task. Intention-to-treat analyses were stratified by maternal HIV status.
Results Compared with SOC, children randomised to combined IYCF +WASH had higher total MDAT scores (mean difference +4.6; 95% CI 1.9 to 7.2) and MacArthur Bates vocabulary scores (+8.5 words; 95% CI 3.7 to 13.3), but there was no evidence of effects from IYCF or WASH alone. There was no evidence that that any intervention impacted object permanence or self-control.
Conclusions Combining IYCF and WASH interventions significantly improved motor, language and cognitive development in HIV-exposed children.
Trial registration number NCT01824940.
- early child development
- complementary feeding
- sanitation
- hand washing
- safe drinking water
- HIV
- HIV-exposed uninfected
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Footnotes
Handling editor Seye Abimbola
Twitter @jayachandna, @NtoziniRobert, @mjgladstone
Contributors JC was involved with data curation, formal analysis, methodology, project administration, validation, writing—original draft, writing—review and editing. RN was involved with data curation, formal analysis, methodology, validation, writing—review and editing. CE was involved with formal analysis, methodology, writing—original draft, and writing—review and editing. GK was involved with conceptualisation, methodology, supervision, validation, writing—review and editing. BC was involved with data curation, formal analysis, methodology and reviewing and editing. FM was involved with data curation, methodology, project administration, validation, writing—review and editing. KM was involved with data curation, methodology and review and editing. NT was involved in data curation, methodology, project administration, writing—review and editing. BM was involved in data curation, analysis and review and editing. MM was involved in conceptualisation, data curation, funding acquisition, investigation, methodology, project administration, resources, supervision, writing—review and editing. LHM was involved in conceptualisation, formal analysis, investigation, methodology, writing—review and editing. JHH was involved with conceptualisation, data curation, funding acquisition, investigation, methodology, project administration, resources, supervision, writing—review & editing. AP was involved with conceptualisation, data curation, funding acquisition, investigation, methodology, project administration, resources, supervision, writing—review and editing. MG was involved with conceptualisation, data curation, methodology, supervision, validation, writing—original draft, writing—review and editing.
Funding Funded by the Bill & Melinda Gates Foundation (OPP1021542 and OPP1143707); the United Kingdom Department for International Development (DFID/UKAID); Wellcome Trust (093768/Z/10/Z, 108065/Z/15/Z and 203905/Z/16/Z); Swiss Agency for Development and Cooperation; US National Institutes of Health (2R01HD060338-06); and UNICEF (PCA-2017-0002).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The Medical Research Council of Zimbabwe and the Institutional Review Board of the Johns Hopkins Bloomberg School of Public Health approved the study protocol.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on request. Data will be freely available as individual participant data with an accompanying data dictionary at http://ClinEpiDB.org from late 2019. This platform is charged with ensuring that epidemiological studies are fully anonymised by removing all personal identifiers and obfuscating all dates per participant through application of a random number algorithm to comply with the ethical conduct of human subjects research. Researchers must agree to the policies and comply with the mechanism of ClinEpiDB to access data housed on this platform. Prior to that time, the data are housed on the ClinEpiDB platform at the Zvitambo Institute for Maternal and Child Health Research and available on request from Virginia Sauramba (vsauramba@zvitambo.co.zw).