Clinical Trial: The Effect of an Urban Sanitation Intervention on Child Health

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: London School of Hygiene and Tropical Medicine

Current Primary Outcome: Combined prevalence of bacterial and protozoan enteric infections [ Time Frame: 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


Original Primary Outcome: Combined prevalence of bacterial, viral, and protozoan enteric infections [ Time Frame: 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; adenovirus 40/41; norovirus GI/GII; rotavirus A; Giardia; Cryptosporidium; and Entamoeba histolytica


Current Secondary Outcome:

  • Combined helminth re-infection at 1 year following baseline de-worming [ Time Frame: 12 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 [ Time Frame: 12 month follow-up ]
    We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.


Original Secondary Outcome:

  • Combined helminth re-infection at 1 year following baseline de-worming [ Time Frame: 12 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, Enterobius spp., Taenia spp., and Hymenolepis spp., and Strongyloides spp.
  • Period prevalence (7-day recall) of gastrointestinal illness [ Time Frame: 12 month follow-up ]
    We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.


Information By: London School of Hygiene and Tropical Medicine

Dates:
Date Received: February 4, 2015
Date Started: February 2015
Date Completion: March 2017
Last Updated: September 12, 2016
Last Verified: September 2016