The Effect of an Urban Sanitation Intervention on Child Health

Not Applicable

Completed

• Conditions: Helminthiasis; Diarrhea
• Interventions: Other: Sanitation

• Registration Number: NCT02362932
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

The purpose of this study is to determine the health impact of a basic sanitation intervention in Maputo, Mozambique.

Detailed Description

We have designed a controlled, before-and-after (CBA) effectiveness study to estimate the health impacts of an urban sanitation intervention in informal neighborhoods of Maputo, Mozambique, including an assessment of whether exposures and health outcomes vary by localized population density. The intervention consists of private pour-flush latrines (to septic tank) shared by multiple households in compounds or household clusters. We will measure objective health outcomes in approximately 1000 children (500 children with household access to interventions, 500 controls using existing shared private latrines in poor sanitary conditions), at two time points: immediately before the intervention and at follow-up after 12 months. The primary outcome is combined prevalence of enteric infections among children under 5 years of age. Secondary outcome measures include soil transmitted helminth (STH) re-infection in children following baseline de-worming and prevalence of reported gastrointestinal illness. We will use exposure assessment, fecal source tracking, and microbial transmission modeling to examine whether and how routes of exposure for diarrheagenic pathogens and STHs vary and transmission impacts of the pathogens following introduction of effective sanitation. Our analysis will focus specifically on the impact of localized population density as a potential modifier of sanitation-related exposures.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Status Verified: 2018-08
• Primary Completion: 2018-09-05
• Study Completion: 2018-09-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1866

Inclusion Criteria

• Children normally resident in households with access to new shared sanitation (the intervention) as selected by implementing organisation (WSUP) or control children normally resident in households sharing existing shared sanitation within geographically delimited project bounds and meeting WSUP site selection criteria (including number of people served)

Exclusion Criteria

• Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Sanitation	Sanitation

Primary Outcome Measures

Name	Time	Method
Combined prevalence of bacterial and protozoan enteric infections	12 month follow-up	As identified via molecular assays on stool samples, we will measure combined prevalence of the following enteric infections: Campylobacter; Clostridium difficile, Toxin A/B; E. coli O157; Enterotoxigenic E. coli (ETEC) LT/ST; Shiga-like toxin producing E. coli (STEC) stx1/stx2; Salmonella; Shigella; Vibrio cholerae; Yersinia enterocolitica; Giardia; Cryptosporidium; and Entamoeba histolytica

Secondary Outcome Measures

Name	Time	Method
Combined helminth re-infection at 1 year following baseline de-worming	24 month follow-up	Combined prevalence of the following soil-transmitted helminths, as measured in stool samples via the Kato-Katz method: Ascaris spp., Trichuris spp., hookworm
Period prevalence (7-day recall) of gastrointestinal illness	24 month follow-up	We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.
Height-for-age z-score	24 month follow-up	Height, measured by length/height boards, standardised to z-scores against WHO 2009 Child Growth Standards
Combined prevalence of bacterial and protozoan enteric infections	24 month follow-up	As identified via molecular assays on stool samples, we will measure combined prevalence of the following enteric infections: Campylobacter; Clostridium difficile, Toxin A/B; E. coli O157; Enterotoxigenic E. coli (ETEC) LT/ST; Shiga-like toxin producing E. coli (STEC) stx1/stx2; Salmonella; Shigella; Vibrio cholerae; Yersinia enterocolitica; Giardia; Cryptosporidium; and Entamoeba histolytica

Trial Locations

Locations (1)

Health Research for Development; 🇲🇿 Maputo, Mozambique