HygieneNCT02342860
The Impact of Improved WASH in Schools on Absence, Diarrhea and Helminth Infection in Lao PDR
A study testing WASH in Schools (WinS) programme in people with Hygiene, run by Emory University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hygiene
- What is being tested?
- WASH in Schools (WinS) programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,873 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
Official title: Measuring the Impact of WASH in Schools in the Lao People's Democratic Republic
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.
Read the 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.
- Conditions
- Hygiene
- Being tested
- WASH in Schools (WinS) programme
- Keywords
- Water, sanitation, hygiene access in school
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WASH in Schools (WinS) programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: WASH in Schools (WinS) programme |
| Control | No intervention | Schools in the control group will receive no additional WinS programming. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil absenteeism
Rates of pupil absenteeism from school, measured through roll call, review of teacher records, and pupil self-report
Measured: 20 months
Secondary outcomes (3)
Pupil educational attainment ( measured through review of school/teacher records)
Enrollment, attrition, progression, and performance will be measured through review of school/teacher records
Measured: 20 months
Pupil health attainment (measured through pupil self-report)
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
Measured: 20 months
Behavior change (Handwashing behavior and proxy indicators of WASH facility usage will be measured using structured observation)
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
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startSep 2014
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HygieneStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Responsible party
- Principal investigator, Matthew Freeman, MPH, PhD, Emory University
- Investigators
- Matthew C Freeman, PhD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342860
- Sponsor's protocol ID
- IRB00076404
- Status last verified
- May 2019
- First submitted
- 9 Jan 2015
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29565302Chard 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.
PubMed 32267881
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of WASH in Schools in the Lao People's Democratic Republic
- ClinicalTrials.gov ID
- NCT02342860
- Acronym / sponsor ID
- IRB00076404
- Conditions
- Hygiene
- Keywords
- Water, sanitation, hygiene access in school
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,873 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- Sep 2014
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WASH in Schools (WinS) programme | Experimental | Other: WASH in Schools (WinS) programmeSchools 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. |
| Control | No intervention | –Schools in the control group will receive no additional WinS programming. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WASH in Schools (WinS) programmeThe 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. | Other | WASH in Schools (WinS) programme |
Primary outcome
Pupil absenteeism
Time frame: 20 months
Rates of pupil absenteeism from school, measured through roll call, review of teacher records, and pupil self-report
3 secondary outcomes
Pupil educational attainment ( measured through review of school/teacher records)
Time frame: 20 months
Pupil health attainment (measured through pupil self-report)
Time frame: 20 months
Behavior change (Handwashing behavior and proxy indicators of WASH facility usage will be measured using structured observation)
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Results publication: PubMed 29565302Chard 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.
- Derived from this study: PubMed 32267881Chard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew C Freeman, PhD, MPH principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing WASH in Schools (WinS) programme in people with Hygiene, run by Emory University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil absenteeism (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342860, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.