- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02342860
The Impact of Improved WASH in Schools on Absence, Diarrhea and Helminth Infection in Lao PDR
Measuring the Impact of WASH in Schools in the Lao People's Democratic Republic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Though limited, research suggests school-based water, sanitation and hygiene (WASH) improvements are capable of reducing pupil absence from 35-42%. However, few studies have rigorously evaluated the impact of comprehensive WASH in Schools (WinS) improvements on pupil absenteeism; to date, no research on the impact of WinS has been conducted in Lao PDR. This study will use longitudinal data collection to quantify the impact of UNICEF's WinS program on pupil learning and health in Lao People's Democratic Republic (Lao PDR).
Research activities will take place Saravane Province, Lao PDR. Schools are eligible if they are a primary, non-Community-Built Construction (CBC) school, and lacking WASH facilities. A total of 136 schools will be randomly selected from a pool of all eligible schools, and randomly assigned to either the intervention or comparison group (68 schools each). Directors of the selected schools will be contacted and informed about procedures prior to the start of the study, and they will provide permission to conduct the study at their schools if they so choose. At each school the investigators will randomly select up to 60 pupils in grades 1-5. 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 Laotian or a local dialect. Oral rather than written assent was chosen due to varied literacy capabilities and to limit paperwork that identifies participants. A waiver of parental consent for pupil interviews has been secured from the Ministry of Education and Sports. At each school, school directors will be asked to sign in loco parentis ("in the place of parent") on behalf of the pupil participants.
Data collection will take place at each school once every six to eight weeks for the duration of up to three school years. The investigators will conduct school observations and an interview with the school director about school conditions, handwashing behavior observations of children, and a review of aggregate school-wide academic record data including percentage of children obtaining a passing average, advancing to the next class, and drop-outs. None of these school activities collect personal data or identifiers. Data collection with pupils will be done with the same pupils every six to eight weeks and will entail a five-minute interview asking about recent absence, symptoms of diarrhea or respiratory illness, age, and grade. Select pupils in a subset of schools will undergo testing for cognition, attention, and hydration. Select pupils in a subset of school will provide a stool sample for analyses of helminth infection prior to school-wide de-worming. Data collection will also take place at the household of select pupils in a subset of schools. The investigators will conduct a household survey once at the beginning of each school year to assess the range of household WASH access among pupils in study selected schools.
All data collection will occur at the school or the household, 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, but rather a pupil identification . Enumerators will maintain a separate form that links identifications with names of pupils, 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WASH in Schools (WinS) programme
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.
|
The intervention group will receive the UNICEF/DFAT-supported WinS programme, which consists of the following intervention package:
|
No Intervention: Control
Schools in the control group will receive no additional WinS programming.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pupil absenteeism
Time Frame: 20 months
|
Rates of pupil absenteeism from school, measured through roll call, review of teacher records, and pupil self-report
|
20 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pupil educational attainment ( measured through review of school/teacher records)
Time Frame: 20 months
|
Enrollment, attrition, progression, and performance will be measured through review of school/teacher records
|
20 months
|
Pupil health attainment (measured through pupil self-report)
Time Frame: 20 months
|
Diarrhea, respiratory infection, and conjunctivitis will be measured through pupil self-report; hydration will be measured through analysis of urine specific gravity; helminth prevalence and infection intensity will be measured through analysis of stool samples
|
20 months
|
Behavior change (Handwashing behavior and proxy indicators of WASH facility usage will be measured using structured observation)
Time Frame: 20 months
|
Handwashing behavior and proxy indicators of WASH facility usage will be measured using structured observation; household and school WASH facility usage will be measured through pupil self-report
|
20 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew C Freeman, PhD, MPH, Emory University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00076404
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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