NCT02362932

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,866

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2018

Completed
Last Updated

May 14, 2019

Status Verified

August 1, 2018

Enrollment Period

3.6 years

First QC Date

February 4, 2015

Last Update Submit

May 10, 2019

Conditions

Outcome Measures

Primary Outcomes (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

    12 month follow-up

Secondary Outcomes (6)

  • Combined helminth re-infection at 1 year following baseline de-worming

    12 month follow-up

  • Combined helminth re-infection at 1 year following baseline de-worming

    24 month follow-up

  • Period prevalence (7-day recall) of gastrointestinal illness

    12 month follow-up

  • Period prevalence (7-day recall) of gastrointestinal illness

    24 month follow-up

  • Height-for-age z-score

    24 month follow-up

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Sanitation

Other: Sanitation

Control

NO INTERVENTION

No sanitation

Interventions

Shared sanitation

Intervention

Eligibility Criteria

Age29 Days - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Research for Development

Maputo, Maputo, Mozambique

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

DiarrheaHelminthiasis

Interventions

Sanitation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

Communicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Joe Brown, PhD

    Georgia Institute of Technology (Georgia Tech)

    PRINCIPAL INVESTIGATOR
  • Oliver Cumming, MSc

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 13, 2015

Study Start

February 1, 2015

Primary Completion

September 5, 2018

Study Completion

September 5, 2018

Last Updated

May 14, 2019

Record last verified: 2018-08

Locations