Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of an Urban Sanitation Intervention on Child Health (MapSan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02362932
Recruitment Status : Completed
First Posted : February 13, 2015
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diarrhea Helminthiasis Other: Sanitation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1866 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : February 2015
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Sanitation
Other: Sanitation
Shared sanitation

No Intervention: Control
No sanitation



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Combined helminth re-infection at 1 year following baseline de-worming [ Time Frame: 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

  3. 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.

  4. Period prevalence (7-day recall) of gastrointestinal illness [ Time Frame: 24 month follow-up ]
    We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.

  5. Height-for-age z-score [ Time Frame: 24 month follow-up ]
    Height, measured by length/height boards, standardised to z-scores against WHO 2009 Child Growth Standards

  6. Combined prevalence of bacterial and protozoan enteric infections [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362932


Locations
Layout table for location information
Mozambique
Health Research for Development
Maputo, Mozambique, Maputo
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
Layout table for investigator information
Principal Investigator: Joe Brown, PhD Georgia Institute of Technology (Georgia Tech)
Study Director: Oliver Cumming, MSc London School of Hygiene and Tropical Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02362932    
Other Study ID Numbers: 8345
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Helminthiasis
Diarrhea
Signs and Symptoms, Digestive
Parasitic Diseases