NCT01787058

Brief Summary

This study will use longitudinal data collection to quantify the impact of a school-based water, sanitation and hygiene (WASH) program in Mali, West Africa, on pupil absenteeism, diarrheal illness, and respiratory illness. Data will be collected from 100 intervention and 100 control schools across 4 regions in Mali. At each school research staff will randomly select 60 pupils in grades 3-6 (typically ages 7-14). Research staff will ask school directors to provide written consent for pupil participation in place of parents, a procedure that has been approved by the Malian Ministry of Education. Research staff will approach selected pupils at school to request informed oral assent for participation. The informed assent process and data collection will be conducted by local trained enumerators in the child's preferred language of French or Bambara. Oral rather than written assent was chosen due to varied literacy capabilities and to limit paperwork that identifies participants. Data collection will take place at each school once every six to eight weeks during the duration of two school years. Research staff will conduct observations of school facilities, observations of handwashing behavior of children upon leaving latrines, and an interview with the school director about WASH conditions and school enrollment information. None of these school activities collect personal data or identifiers. Data collection with pupils will be done with the same pupils every 6-8 weeks and entails a 5-minute interview asking about recent absence and symptoms of diarrhea and respiratory illness. All data collection will occur at the school, will be conducted by trained local enumerators, and will be stored on password-protected mobile data collection devices. Data will be uploaded to a password-protected server and will not contain personal identifying information. Enumerators will maintain a separate form that links pupil IDs with names, which will be kept confidential. There are no direct benefits other than contribution to general knowledge that will inform future school WASH projects. There are no risks to participation other than a small amount of class time missed by pupils, and great efforts will be made to minimize time outside of class.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

February 1, 2013

Last Update Submit

May 2, 2019

Conditions

Keywords

WASHschoolchildrenabsenteeism

Outcome Measures

Primary Outcomes (1)

  • Absenteeism rate

    This indicator measures whether a pupil is absent on the day of a study staff visit. An all-school roll call will be used to measure single-day absenteeism for all pupils in grades 1-6. This indicator is collected longitudinally over the course of the trial with a time point every 6-8 weeks. Investigators will compare rates in intervention and control groups. This outcome is not a change outcome or a single outcome. It is a rate, which is a count of events over a specified period of time. This outcome measures more than one time point.

    Every 6-8 weeks. Partcipants will be followed for 16 months (February 2013-June 2014)

Secondary Outcomes (4)

  • 7-day period prevalence of absenteeism

    Every 6-8 weeks. Participants will be followed for 16 months (February 2013-June 2014)

  • 7-day period prevalence of respiratory infection

    Longitudinal prevalence: Baseline and every 6-8 weeks. Participants will be followed for 16 months (February 2013-June 2014)

  • 2- and 7-day period prevalence of diarrhea

    Longitudinal prevalence: Baseline and every 6-8 weeks. Participants will be followed for 16 months (February 2013-June 2014)

  • Prevalence of blood antibodies for enteric and neglected tropical diseases

    Once, between February and March 2014

Other Outcomes (3)

  • Retention percentage

    Baseline and every 6-8 weeks. Participants will be followed for 16 months (February 2013-June 2014)

  • Pass percentage

    3 months and 15 months (corresponding with end of school year June 2013 and June 2014)

  • Progression percentage

    3 months and 15 months (corresponding with end of school year June 2013 and June 2014)

Study Arms (2)

Dubai Cares beneficiary

Pupils who attend a school that has benefitted from a water, sanitation and hygiene intervention as part of the Dubai Cares program.

Other: Dubai Cares beneficiary

Control

Pupils who attend a school of the same size and location as a school that benefitted from a water, sanitation and hygiene (WASH) intervention through the Dubai Cares program, but which has not benefitted from that program or any other WASH program since 2009.

Interventions

Installation or rehabilitation of school water points, latrines and hygiene kits; promotion of good WASH practices and behavior change at school and within the community; establishment of management systems to ensure sustained WASH financing, monitoring and maintenance.

Dubai Cares beneficiary

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Primary school students attending public schools in the Koulikoro, Sikasso, Bamako, and Mopti regions of Mali

You may qualify if:

  • Attendance in a school that was randomly sampled from either the list of schools participating in the Dubai Cares water, sanitation and hygiene program or a list of non-program schools of the same size and in the same geographic area as a program school.
  • In 3-6 grades

You may not qualify if:

  • Inability to understand basic questions asked in French or one of three common local languages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bamako, Sikasso, Koulikoro, and Mopti Regions

Bamako, Mali

Location

Related Publications (3)

  • Trinies V, Garn JV, Chang HH, Freeman MC. The Impact of a School-Based Water, Sanitation, and Hygiene Program on Absenteeism, Diarrhea, and Respiratory Infection: A Matched-Control Trial in Mali. Am J Trop Med Hyg. 2016 Jun 1;94(6):1418-25. doi: 10.4269/ajtmh.15-0757. Epub 2016 Apr 25.

  • Chard AN, Trinies V, Moss DM, Chang HH, Doumbia S, Lammie PJ, Freeman MC. The impact of school water, sanitation, and hygiene improvements on infectious disease using serum antibody detection. PLoS Negl Trop Dis. 2018 Apr 16;12(4):e0006418. doi: 10.1371/journal.pntd.0006418. eCollection 2018 Apr.

  • Rogier E, Moss DM, Chard AN, Trinies V, Doumbia S, Freeman MC, Lammie PJ. Evaluation of Immunoglobulin G Responses to Plasmodium falciparum and Plasmodium vivax in Malian School Children Using Multiplex Bead Assay. Am J Trop Med Hyg. 2017 Feb 8;96(2):312-318. doi: 10.4269/ajtmh.16-0476. Epub 2016 Nov 28.

MeSH Terms

Conditions

DiarrheaRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsRespiratory Tract Diseases

Study Officials

  • Matthew C Freeman, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 8, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations