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DiarrheaMapSanNCT02362932

The Effect of an Urban Sanitation Intervention on Child Health

A study testing Sanitation in people with Diarrhea and Helminthiasis, run by London School of Hygiene and Tropical Medicine at 1 site in Mozambique.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 29 days to 48 months
Conditions the study is for
Diarrhea, Helminthiasis
What is being tested?
Sanitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,866 participants
Where
1 siteMozambique
Study dates
Feb 2015to 5 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 29 days to 48 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • Refusal to participate

Trial locations and contacts

1 site in 1 country.

Mozambique1 site

  • Health Research for Development

    Maputo, Maputo

Other trials in Mozambique

About this study

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

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

Read the 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.

Being tested
Sanitation
Medical subject headings
Diarrhea, Helminthiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SanitationOther

    Shared sanitation

Study groups in NCT02362932
Study groupRoleWhat they receive
InterventionExperimentalSanitation
Receives: Other: Sanitation
ControlNo interventionNo sanitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 month follow-up

Secondary outcomes (6)

  1. 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

    Measured: 12 month follow-up

  2. 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

    Measured: 24 month follow-up

  3. Period prevalence (7-day recall) of gastrointestinal illness

    We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.

    Measured: 12 month follow-up

  4. Period prevalence (7-day recall) of gastrointestinal illness

    We will measure caregiver-reported symptoms of gastrointestinal illness, including diarrhea, vomiting, and abdominal pain.

    Measured: 24 month follow-up

  5. Height-for-age z-score

    Height, measured by length/height boards, standardised to z-scores against WHO 2009 Child Growth Standards

    Measured: 24 month follow-up

  6. 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

    Measured: 24 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion5 Sep 2018
  4. Study completion5 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,866 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02362932
Sponsor's protocol ID
8345
Acronym
MapSan
Status last verified
Aug 2018
First submitted
4 Feb 2015
Last updated
14 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Holcomb DA, Monteiro V, Capone D, Antonio V, Chiluvane M, Cumbane V, Ismael N, Knee J, Kowalsky E, Lai A, Linden Y, Mataveia E, Nala R, Rao G, Ribeiro J, Cumming O, Viegas E, Brown J. Long-term impacts of an urban sanitation intervention on enteric pathogens in children in Maputo city, Mozambique: study protocol for a cross-sectional follow-up to the Maputo Sanitation (MapSan) trial 5 years postintervention. BMJ Open. 2023 Jun 8;13(6):e067941. doi: 10.1136/bmjopen-2022-067941.

    PubMed 37290945

  • 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.

    PubMed 34271913

  • 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.

    PubMed 33835026

  • 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.

    PubMed 30419034

  • 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.

    PubMed 26088809

Questions about this trial

What is this clinical trial studying?

A study testing Sanitation in people with Diarrhea and Helminthiasis, run by London School of Hygiene and Tropical Medicine at 1 site in Mozambique.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined prevalence of bacterial and protozoan enteric infections (time frame: 12 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02362932, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.

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