Does providing a sealed, washable domestic floor to households in rural Kenya improve health?

Not Applicable

• Conditions: Prevention of enteric infections and tungiasis in children and soil-transmitted helminthiasis in all ages living in rural Kenya; Infections and Infestations

• Registration Number: ISRCTN82018262
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-14
• Last Update Posted: 26 June 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 4400

Inclusion Criteria

1. Resident in a household with a child under 5 years of age
2. Dwelling where child under 5 sleeps meet structural criteria (unimproved earthen flooring throughout, structurally sound)
3. All household members willing to temporarily relocate whilst floors are laid

Exclusion Criteria

1. No child under 5 years of age resident in the household
2. Dwelling where a child aged under 5 years sleeps has improved floor (i.e. cement or tiled) or is not structurally sound
3. Household is intending to move within the next 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Enteric infections: Prevalence of enteric infections in children under 5 years old measured using PCR analysis of stool at baseline and 12 months after receiving the floors. Pathogens identified from those observed at baseline using a multipathogen panel on a subset of 100 samples.<br>2. Tungiasis infections: Prevalence of tungiasis (detected through clinical examination of hands and feet) in children under 15 years old at baseline and 12 months after receiving the floors. <br>3. STH infections: Prevalence of at least one STH infection (hookworm, acsaris and trichuris infections; detected through Kato Katz of stool samples) in all household members 12 months and older at baseline and 12 months after receiving the floors.

Secondary Outcome Measures

Name	Time	Method
1. Gastrointestinal illness measured using caregiver-reported symptoms at baseline and 12 months<br>2. Severity of acute and chronic tungiasis-associated pathology in children <15 years assessed using clinical severity scores at baseline and 12 months<br>3. Quality of life for children aged 8 to 14 years assessed using the standardised EQ5D-Y tool at baseline and 12 months<br>4. Quality of life in primary caregivers assessed using the standardised EQ5D tool at baseline and 12 months<br>5. Prevalence of Ascaris lumbricoides infection in all household members >1 year assessed using Kato Katz at baseline and 12 months<br>6. Prevalence of hookworm infection in all household members >1 year assessed using Kato Katz at baseline and 12 months<br>7. Prevalence of Trichuris trichiura infection in all household members >1 year assessed using Kato Katz at baseline and 12 months<br>8. Contamination of floors with eggs, larvae, pupae and adults of T. penetrans, assessed through entomology soil surveys at 6 months