The Effect of an Urban Sanitation Intervention on Child Health

Diarrhea Clinical Trial

— MapSan  

Official title:

A Controlled Before and After Study to Measure the Effect of an Urban Sanitation Intervention on Child Health, in Low-income Neighborhoods of Maputo, Mozambique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362932
• Other study ID #: 8345
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 5, 2018

Study information

• Verified date: August 2018
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1866
• Est. completion date: September 5, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Months

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Helminthiasis

Intervention

Other:
• Sanitation
Shared sanitation

Locations

Country	Name	City	State
Mozambique	Health Research for Development	Maputo

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined prevalence of bacterial and protozoan enteric infections	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	12 month follow-up
Secondary	Combined helminth re-infection at 1 year following baseline de-worming	Combined prevalence of the following soil-transmitted helminths, as measured in stool samples via the Kato-Katz method: Ascaris spp., Trichuris spp., hookworm	12 month follow-up
Secondary	Combined helminth re-infection at 1 year following baseline de-worming	Combined prevalence of the following soil-transmitted helminths, as measured in stool samples via the Kato-Katz method: Ascaris spp., Trichuris spp., hookworm	24 month follow-up
Secondary	Period prevalence (7-day recall) of gastrointestinal illness	We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.	12 month follow-up
Secondary	Period prevalence (7-day recall) of gastrointestinal illness	We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.	24 month follow-up
Secondary	Height-for-age z-score	Height, measured by length/height boards, standardised to z-scores against WHO 2009 Child Growth Standards	24 month follow-up
Secondary	Combined prevalence of bacterial and protozoan enteric infections	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	24 month follow-up