NCT02342860

Brief Summary

The investigators will conduct a cluster-randomized trial to assess the impact of a school-based water, sanitation and hygiene program on health and educational outcomes of school children in Saravane Province, Laos. The intervention will include an improved water supply (borehole), a sanitation block that includes three pour-flush latrines with rainwater harvesting to be used for flushing and a urinal, and sinks for handwashing with soap. The school will also receive a facility for group handwashing (large pipe where many children can wash hands at once. United Nations International Children's Emergency Fund (UNICEF) will additionally provide behavior change education. Our key outcome of interest is pupil absence, which will be measured longitudinally using roll-call on days of schools visits. Secondary outcomes include self-reported absence, diarrhea and respiratory infection of a random selection of students. The investigators will also monitor the fidelity of the intervention and assess school conditions and pupil sanitation and handwashing behaviors using structured observation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8,873

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

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

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

2.6 years

First QC Date

January 9, 2015

Last Update Submit

May 2, 2019

Conditions

Keywords

Watersanitationhygiene access in school

Outcome Measures

Primary Outcomes (1)

  • Pupil absenteeism

    Rates of pupil absenteeism from school, measured through roll call, review of teacher records, and pupil self-report

    20 months

Secondary Outcomes (3)

  • Pupil educational attainment ( measured through review of school/teacher records)

    20 months

  • Pupil health attainment (measured through pupil self-report)

    20 months

  • Behavior change (Handwashing behavior and proxy indicators of WASH facility usage will be measured using structured observation)

    20 months

Study Arms (2)

WASH in Schools (WinS) programme

EXPERIMENTAL

Schools in the intervention group will receive the UNICEF/Department of Foreign Affairs and Trade (DFAT)-supported WinS programme that includes a new water supply, 3 latrines (boys, girls, handicapped), and handwashing facilities. It will also include behavior change education.

Other: WASH in Schools (WinS) programme

Control

NO INTERVENTION

Schools in the control group will receive no additional WinS programming.

Interventions

The intervention group will receive the UNICEF/DFAT-supported WinS programme, which consists of the following intervention package: * Hardware: water supply system, handwashing station for group handwashing, and gender-segregated toilets with one facility accessible to students with physical disabilities; * Software: operations and maintenance (O\&M) training for teachers, hygiene training, and basic hygiene package.

WASH in Schools (WinS) programme

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Schools must meet the following criteria to be eligible for inclusion in the study: * Located in the Saravane, Ta Oy, Toumlane, Lakhonepheng, Vapy, Khongsedone, Lao Ngam, and Samoui Districts * Non-Community-Based Construction (CBC) school * Primary school * Lacking functional WASH facilities * If part of a complex, no other schools in the complex have already been selected to participate in the study. Pupils must meet the following criteria to be eligible for inclusion in the study: * Grades 3-5 in study selected schools * Understand and respond to study assent process

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Chard AN, Freeman MC. Design, Intervention Fidelity, and Behavioral Outcomes of a School-Based Water, Sanitation, and Hygiene Cluster-Randomized Trial in Laos. Int J Environ Res Public Health. 2018 Mar 22;15(4):570. doi: 10.3390/ijerph15040570.

  • Chard AN, Levy K, Baker KK, Tsai K, Chang HH, Thongpaseuth V, Sistrunk JR, Freeman MC. Environmental and spatial determinants of enteric pathogen infection in rural Lao People's Democratic Republic: A cross-sectional study. PLoS Negl Trop Dis. 2020 Apr 8;14(4):e0008180. doi: 10.1371/journal.pntd.0008180. eCollection 2020 Apr.

MeSH Terms

Interventions

Therapeutic IrrigationSchools

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative TechniquesNon-Medical Public and Private Facilities

Study Officials

  • Matthew C Freeman, PhD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 21, 2015

Study Start

September 1, 2014

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

May 6, 2019

Record last verified: 2019-05