The Safe Start Trial - Kisumu, Kenya

Diarrhea Clinical Trial

Official title:

The Safe Start Trial: a Cluster Randomised Controlled Trial for the Effect of a Food Hygiene Intervention on Infant Enteric Infections and Diarrhoeal Disease in Low-income Informal Settlements of Kisumu, Kenya.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468114
• Other study ID #: 14695
• Status: Completed
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: June 22, 2019

Study information

• Verified date: August 2019
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: June 22, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Weeks to 23 Weeks

Eligibility

Inclusion Criteria:

• Infant is 21-23 weeks of age at enrolment

• Infant's mother residing within catchment of participating health extension worker at time of enrolment and intends to stay in current dwelling at least until infant reaches 37 weeks of age

Exclusion Criteria:

• Infant with any medical, psychiatric or social condition which, in the opinion of the research team, impedes the participant's ability to give informed consent

Related Conditions & MeSH terms

• Diarrhea
• Enteric Infections
• Infection

Intervention

Behavioral:
• Safe Start
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).
• Active Control
Participant households will receive 4 visits by health extension workers delivering standard care

Locations

Country	Name	City	State
Kenya	Great Lakes University Kisumu	Kisumu

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Great Lakes University Kisumu, University of Iowa

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause mortality incidence	Deaths occurring during follow-up due to any cause	Between 22 and 37 weeks of age (+/- 1 week)
Primary	Enteric infection prevalence	Enteric infections are defined as the presence of enteric pathogens in stool as indicated by 1 or more of these 23 genetic sequences: Shigella/EIEC virulence plasmid, EAEC_aaic, EAEC_aata, EPEC_eae, EPEC_bfpa, ETEC_LT, ETEC_STp_STh, EHEC Escherichia coli 0157, Aeromonas, Vibrio cholerae, Campylobacter jejuni/C. coli, Clostridium difficile, and Salmonella enterica), Adenovirus 40/41, Adenovirus Hexon, Norovirus GI, Norovirus GII, and Rotavirus and broad reactive Cryptosporidium_18s, C. hominus, C. parvum, and Giardia assemblages A & B.	At 37 weeks of age (+/- 1 week)
Primary	Diarrhoeal disease longitudinal prevalence	Longitudinal prevalence is defined by days with diarrhoea during follow-up with diarrhoea defined according to WHO definition (3 or more loose or liquid stools passed within 24 hours)	Between 22 and 37 weeks of age (+/- 1 week)