Clinical trial NCT02362932: The Effect of an Urban Sanitation Intervention on Child Health
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
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Helminthiasis
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 1866
Sex: ALL
Minimum age (years): 29
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Combined prevalence of bacterial and protozoan enteric infections
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Combined helminth re-infection at 1 year following baseline de-worming
timeFrame: 12 month follow-up
measure: Combined helminth re-infection at 1 year following baseline de-worming
timeFrame: 24 month follow-up
measure: Period prevalence (7-day recall) of gastrointestinal illness
timeFrame: 12 month follow-up
measure: Period prevalence (7-day recall) of gastrointestinal illness
timeFrame: 24 month follow-up
measure: Height-for-age z-score
timeFrame: 24 month follow-up
measure: Combined prevalence of bacterial and protozoan enteric infections
timeFrame: 24 month follow-up
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: Health Research for Development
Study officials:
affiliation: Georgia Institute of Technology (Georgia Tech)
name: Joe Brown, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Oliver Cumming, MSc
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.