The Safe Start Trial - Kisumu, Kenya
Condition: Enteric Infections; Diarrhea
MeSH terms: Infections; Diarrhea
Study type: Interventional

Summary: 
      This a cluster randomised controlled trial (cRCT) to evaluate the effect of a novel food
      hygiene intervention on infant health.
    

Detailed description: 
      Enteric infections remain a major threat to child health and development in many low and
      middle-income countries. Globally, diarrhoeal disease - a key health consequence of enteric
      infection - is ranked as the fourth leading cause of disability globally, after ischaemic
      heart disease, lower respiratory tract infections and strokes. Diarrhoeal disease persists as
      the second leading cause of child deaths in the world, and in sub-Saharan Africa is the
      leading cause of child deaths.

      Public health efforts to address diarrhoeal disease have largely focused on improving access
      to safe drinking water and sanitation and promoting hand washing with soap to address
      faecal-oral routes of transmission. These interventions though may not effectively address
      all exposure pathways during early life, when young children are most susceptible to
      infection and the diarrhoeal disease burden is greatest. One potentially important exposure
      pathway is infant food which recent studies conducted in low income, high burden settings
      suggest may be highly contaminated and may be amenable to simple behaviour change
      interventions.

      The Safe Start trial will evaluate the effect of a novel food hygiene intervention on infant
      health implemented in low income urban neighbourhoods of Kisumu, Kenya. The intervention is
      designed to target early childhood exposure to enteric pathogens through contaminated food
      and was developed through an earlier phase of formative behavioural and microbiological
      research. The intervention will target infant caregivers and be delivered through the
      Community Health Volunteer (CHV) health extension system. Four key behaviours will be
      addressed by the intervention:

        1. Safe hand hygiene: handwashing with soap before infant food preparation and feeding

        2. Safe food preparation: bringing all infant food to the boil before feeding, including
           when reheating

        3. Safe storage of food: storing all infant food in sealed containers

        4. Safe feeding: reserving specific feeding utensils for the infant and keeping these
           separate and clean

      A cluster randomized controlled trial (cRCT) design will be used to evaluate the intervention
      with each CHV catchment area forming one cluster. The outcomes of interest for this study are
      as follows: (1) the prevalence of enteric infections among infants at 37 weeks of age
      (primary); (2) the longitudinal prevalence of diarrhoea between 22-37 weeks of age (primary);
      and (3) incidence of all-cause mortality between 22-37 weeks of age. Infants will be
      recruited on a rolling basis at 22 weeks of age (+/- 1 week), and data and/or samples
      collected at 3 points: baseline at 22 weeks of age (+/- 1 week); midline at 33 weeks of age
      (+/- 1 week); and endline at 37 weeks of age (+/- 1 week). Stool samples will be collected at
      baseline and endline and analysed for 23 genetic sequences indicating the presence of enteric
      pathogens known to cause childhood diarrhoea in low income, high burden settings.
    

Intervention name(s): Safe Start; Active Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participant households will receive four visits over a 10 week period from health extension workers promoting safe food preparation, storage and feeding, and will be provided with products to support these practices (a bowl, spoon, cup, hand washing station, liquid soap dispenser).; Participant households will receive 4 visits by health extension workers delivering standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention