The Effect of an Urban Sanitation Intervention on Child Health (MapSan)
Primary Purpose
Diarrhea, Helminthiasis
Status
Completed
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
Sanitation
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea
Eligibility 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
Sites / Locations
- Health Research for Development
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Sanitation
No sanitation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Period prevalence (7-day recall) of gastrointestinal illness
We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.
Period prevalence (7-day recall) of gastrointestinal illness
We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.
Height-for-age z-score
Height, measured by length/height boards, standardised to z-scores against WHO 2009 Child Growth Standards
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
Full Information
NCT ID
NCT02362932
First Posted
February 4, 2015
Last Updated
May 10, 2019
Sponsor
London School of Hygiene and Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02362932
Brief Title
The Effect of an Urban Sanitation Intervention on Child Health
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 5, 2018 (Actual)
Study Completion Date
September 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Helminthiasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1866 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Sanitation
Arm Title
Control
Arm Type
No Intervention
Arm Description
No sanitation
Intervention Type
Other
Intervention Name(s)
Sanitation
Intervention Description
Shared sanitation
Primary Outcome Measure Information:
Title
Combined prevalence of bacterial and protozoan enteric infections
Description
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
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
Combined helminth re-infection at 1 year following baseline de-worming
Description
Combined prevalence of the following soil-transmitted helminths, as measured in stool samples via the Kato-Katz method: Ascaris spp., Trichuris spp., hookworm
Time Frame
12 month follow-up
Title
Combined helminth re-infection at 1 year following baseline de-worming
Description
Combined prevalence of the following soil-transmitted helminths, as measured in stool samples via the Kato-Katz method: Ascaris spp., Trichuris spp., hookworm
Time Frame
24 month follow-up
Title
Period prevalence (7-day recall) of gastrointestinal illness
Description
We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.
Time Frame
12 month follow-up
Title
Period prevalence (7-day recall) of gastrointestinal illness
Description
We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.
Time Frame
24 month follow-up
Title
Height-for-age z-score
Description
Height, measured by length/height boards, standardised to z-scores against WHO 2009 Child Growth Standards
Time Frame
24 month follow-up
Title
Combined prevalence of bacterial and protozoan enteric infections
Description
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
Time Frame
24 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Brown, PhD
Organizational Affiliation
Georgia Institute of Technology (Georgia Tech)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oliver Cumming, MSc
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Health Research for Development
City
Maputo
ZIP/Postal Code
Maputo
Country
Mozambique
12. IPD Sharing Statement
Citations:
PubMed Identifier
34271913
Citation
Bick S, Buxton H, Chase RP, Ross I, Adriano Z, Capone D, Knee J, Brown J, Nala R, Cumming O, Dreibelbis R. Using path analysis to test theory of change: a quantitative process evaluation of the MapSan trial. BMC Public Health. 2021 Jul 16;21(1):1411. doi: 10.1186/s12889-021-11364-w.
Results Reference
derived
PubMed Identifier
33835026
Citation
Knee J, Sumner T, Adriano Z, Anderson C, Bush F, Capone D, Casmo V, Holcomb D, Kolsky P, MacDougall A, Molotkova E, Braga JM, Russo C, Schmidt WP, Stewart J, Zambrana W, Zuin V, Nala R, Cumming O, Brown J. Effects of an urban sanitation intervention on childhood enteric infection and diarrhea in Maputo, Mozambique: A controlled before-and-after trial. Elife. 2021 Apr 9;10:e62278. doi: 10.7554/eLife.62278.
Results Reference
derived
PubMed Identifier
30419034
Citation
Knee J, Sumner T, Adriano Z, Berendes D, de Bruijn E, Schmidt WP, Nala R, Cumming O, Brown J. Risk factors for childhood enteric infection in urban Maputo, Mozambique: A cross-sectional study. PLoS Negl Trop Dis. 2018 Nov 12;12(11):e0006956. doi: 10.1371/journal.pntd.0006956. eCollection 2018 Nov.
Results Reference
derived
PubMed Identifier
26088809
Citation
Brown J, Cumming O, Bartram J, Cairncross S, Ensink J, Holcomb D, Knee J, Kolsky P, Liang K, Liang S, Nala R, Norman G, Rheingans R, Stewart J, Zavale O, Zuin V, Schmidt WP. A controlled, before-and-after trial of an urban sanitation intervention to reduce enteric infections in children: research protocol for the Maputo Sanitation (MapSan) study, Mozambique. BMJ Open. 2015 Jun 18;5(6):e008215. doi: 10.1136/bmjopen-2015-008215.
Results Reference
derived
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The Effect of an Urban Sanitation Intervention on Child Health
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