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ObjectivesThe aim of this study was to test whether household environmental hygiene and behavioural conditions moderated associations between diarrhoea and enteric pathogen detection in infants 5 months of age in Kenya and pathogen sources, including latrine access, domestic animal co-habitation and public food sources.DesignCross-sectional study utilising enrolment survey data of households participating in the Safe Start cluster-randomised controlled trial .SettingKisumu, Kenya.ParticipantsA total of 898 caregivers with 5-month (22 week ± 1 week) aged infants were enrolled in the study and completed the enrolment survey.Primary and secondary outcome measuresOutcomes were (1) caregiver-reported 7-day diarrhoea prevalence and (2) count of types of enteric viruses, bacteria and parasites in infant stool. Exposures and effect modifiers included water access and treatment, cohabitation with domestic animals, sanitation access, handwashing practices, supplemental feeding, access to refrigeration and flooring.ResultsReported handwashing after handling animals (adjusted odds ratio (aOR)=0.20; 95% CI=0.06 to 0.50) and before eating (aOR=0.44; 95% CI=0.26 to 0.73) were strongly associated with lower risk of caregiver-reported diarrhoea, while cohabitation with animals (aOR=1.54; 95% CI=1.01 to 2.34) living in a household with vinyl-covered dirt floors (aOR=0.60; 95% CI=0.45 to 0.87) were strongly associated with pathogen codetection in infants. Caregiver handwashing after child (p=0.02) or self-defecation (p=0.03) moderated the relationship between shared sanitation access and infant exposure to pathogens, specifically private latrine access was protective against pathogen exposure of infants in households, where caregivers washed hands after defecation. In the absence of handwashing, access to private sanitation posed no benefits over shared latrines for protecting infants from exposure.ConclusionOur evidence highlights eliminating animal cohabitation and improving flooring, postdefecation and food-related handwashing, and safety and use of cow milk sources as interventions to prevent enteric pathogen exposure of young infants in Kenya.Trial registration numberNCT03468114

ObjectivesDiarrhoea is a leading cause of infant mortality with the main transmission pathways being unsafe water and contaminated food, surfaces and hands. The ‘Safe Start’ trial evaluated a food hygiene intervention implemented in a peri-urban settlement of Kisumu, Kenya, with the aim of reducing diarrhoeagenic enteric infections among infants. Four food hygiene behaviours were targeted: handwashing with soap before preparation and feeding, boiling infant food before feeding, storing infant food in sealed containers, and exclusive use of designated utensils during feeding.MethodsA process evaluation of the intervention was guided by a theory of change describing the hypothesised implementation and receipt of the intervention, mechanisms of change, and the context. These were assessed by qualitative and quantitative data that included debriefing sessions with the delivery teams and Community Health Volunteers (CHVs), and structured observations during food preparation.ResultsThe intervention achieved high coverage and fidelity with over 90% of 814 eligible caregivers participating in the intervention. Caregivers in the intervention arm demonstrated an understanding of the intervention messages, and had 1.38 (95% CI: 1.02–1.87) times the odds of washing hands before food preparation and 3.5 (95% CI: 1.91–6.56) times the odds of using a feeding utensil compared to caregivers in the control group. Contextual factors, especially the movement of caregivers within and outside the study area and time constraints faced by caregivers influenced uptake of some intervention behaviours.ConclusionFuture interventions should seek to explicitly target contextual factors such as secondary caregivers and promote food hygiene interventions as independent of each other.SignificanceWhat is already known on this subject.Diarrhoea is known to be a significant cause of infant morbidity and mortality, mainly through unsafe water and food, and mainly from rural areas.What this study adds.This study describes the implementation of a novel food hygiene intervention to reduce diarrhoea causing enteric infections among children in low income peri urban settlements. The manuscript details the delivery of the intervention, describes the context, and explores associations influencing adoption of the intervention. Findings of the evaluation are meant to support the results of the trial.

Background Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, especially in low-income urban settings. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya. Methods This is a cluster randomized control trial with 50 clusters, representing the catchment areas of Community Health Volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22 weeks of age and then followed for 15 weeks. The intervention targets four key caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all infant food to the boil before feeding; 3) storing all infant food in sealed containers; and, 4) using only specific utensils for infant feeding which are kept separate and clean. Results The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. In addition, infant food samples were collected at 33 weeks, and faecal indicator bacteria ( Enterococcus ) isolated and enumerated to assess the impact of the intervention on infant food contamination. Conclusion To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, low income urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The trial seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the extension system can improve the health of young children.