DiarrheaWISENCT05024890
The Impact of a School-based WASH Intervention on Child Health and School Attendance in Addis Ababa, Ethiopia
A study testing Splash WASH in Schools programme (Project WISE) in people with Diarrhea and Respiratory Tract Infections, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
Trial summary
This study aims to assess the effects of school-based, comprehensive water, sanitation, and hygiene improvements on child health and educational outcomes in schools in Addis Ababa, Ethiopia. Eligible schools will be randomly allocated to intervention or control groups. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Diarrhea, Respiratory Tract Infections, Absenteeism
- What is being tested?
- Splash WASH in Schools programme (Project WISE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,072 participants
- Where
- 1 siteEthiopia
- Study dates
- 2 Nov 2021to 10 Aug 2022
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Main study among older children (7-16 years)
School inclusion criteria:
- School is part of Splash Project WISE implementation groups
- School agrees to participate in the research
School exclusion criteria:
- School has received a water, sanitation, or hygiene intervention in the three years prior to study activities
- School is kindergarten only
- School is secondary only (grades 9 and above, equivalent)
- School provides education to vulnerable population groups only
Child inclusion criteria:
- Child is registered at a school that meets eligibility criteria and selected for the study
- Child is in grades 2-8
- Child's parents do not return the opt-out consent form
- Child provides assent to participate in the research
Child exclusion criteria:
- Child is unable to provide assent for data collection
- Child is 17 or older
- Child does not meet age eligibility for specific data collection activities
Kindergarten evaluation (4-6 years)
School inclusion criteria:
- School is part of Splash Project WISE implementation groups
- School has a kindergarten
- School agrees to participate in the research
School exclusion criteria:
- School has received a water, sanitation, or hygiene intervention in the three years prior to study activities
- School provides education to vulnerable population groups only
Child inclusion criteria:
- Child is registered at a school that meets eligibility criteria and selected for the study
- Child is in kindergarten
- Child's parent/guardian provides consent to participate in the research
Child exclusion criteria:
- Child is 7 or older
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Holster International Research and Development Consultancy
Addis Ababa
About this study
Official title: WASH In Schools for Everyone (WISE): a Randomised Evaluation Assessing the Impact of a School-based Water, Sanitation and Hygiene (WASH) Intervention on Child Health and School Attendance in Addis Ababa, Ethiopia
This study aims to assess the effects of school-based, comprehensive water, sanitation, and hygiene improvements on child health and educational outcomes in schools in Addis Ababa, Ethiopia. Eligible schools will be randomly allocated to intervention or control groups. Data on pupil absence and illness will be collected longitudinally from students in selected classrooms in each school over the course of one academic year (2021/2022). This study will also assess the effects of the intervention on kindergarten students through parent interviews.
Read the detailed description
This study uses a cluster-randomised controlled trial design to evaluate the impact of the WASH in Schools for Everyone (WISE) programme. Project WISE, implemented by Splash, aims to improve child health and attendance by 1) improving WASH infrastructure, 2) promoting WASH behaviour change and 3) strengthening menstrual hygiene management (MHM) services targeting girls aged 10 and above, in public schools across Addis Ababa.
60 public schools from planned implementation groups that will receive the WISE intervention will be randomised: 30 schools will be allocated to the intervention group (to receive the WISE intervention during the 2021/2022 academic year) and 30 schools will be allocated to the control group (on a waitlist to receive the WISE intervention after study completion). Randomisation will be stratified by school size (number of students) and presence of a kindergarten. In each selected school, between two and four classes will be randomly selected from grades 2-8 - to obtain a sample size of approximately 100 students in total per school. Students in the selected classes will be enrolled at the start of the academic year (September 2021) and followed up with unannounced visits every 4-6 weeks until the end of the academic year (May 2022). Primary outcomes of pupil-reported illness and absence will be assessed during enrolment and at each follow-up visit. Secondary outcomes are restricted to subsets of students by age and gender, and will be assessed during the final follow-up visit. Students joining the class mid-way through the year will be enrolled in the study, and students who leave the class will be recorded.
Key outcomes of interest are longitudinal prevalence of absence and illness (diarrhoea and respiratory infection) over the course of the academic year, measured as cumulative number of days absent/with illness per 100 school days after adjustment for child- and school-specific covariates. Data collected in intervention schools prior to and/or during the active Splash intervention will not be included in the primary impact evaluation analysis. Sub-population analysis of evaluation outcomes in girls post-menarche will allow assessment of the gendered effects of the intervention. We will also monitor intervention fidelity and compliance, as well as cost-effectiveness of the intervention, through routine data collection with students and school staff.
40 public schools with a kindergarten will be enrolled to assess the impacts of the intervention among kindergarten students (20 intervention, 20 control). Schools enrolled in the intervention and control arms of the main study among older children that have a kindergarten will be also enrolled in the kindergarten evaluation. If there are fewer than 20 such schools in each arm, additional kindergarten schools will be randomised (estimated 10 additional schools per arm). In each selected school, 20 kindergarten students will be randomly selected for participation. Parents of selected students will be invited to participate in weekly telephone surveys over a four-week period in February/March 2022 in order to assess the longitudinal prevalence of illness and absence among kindergarteners.
- Conditions
- Diarrhea, Respiratory Tract Infections, Absenteeism
- Being tested
- Splash WASH in Schools programme (Project WISE)
- Keywords
- water, sanitation, hygiene, schoolchildren, WASH in schools
- Medical subject headings
- Diarrhea, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splash WASH in Schools programme (Project WISE)Other
The Project WISE intervention includes:
WASH infrastructure
- Water storage tanks and water filtration systems
- Durable plastic drinking water and handwashing stations
- New/rehabilitated toilet facilities (gender-segregated, wheelchair-accessible, well-lit, ventilated, durable door and lock)
Behaviour change promotion
- Training of focal teachers to organise student 'hygiene club'
- Annual soap drive and soap restocking
- Behavioural 'nudges' (posters and mirrors at handwashing stations, colourful vests for hygiene clubs)
MHM services
- Toilets have water tap, bucket and waste bin
- Emergency menstrual hygiene products available at school
- Training of focal teachers to organise student 'gender club'
- Education on puberty and menstruation for all pupils above 10 and parent resource guide
| Study group | Role | What they receive |
|---|---|---|
| WASH in Schools programme | Experimental | Schools in the intervention group will receive the Splash WASH in Schools programme (Project WISE) during the study period (2021/2022 academic year), including sanitation, water storage and filtration, drinking water and handwashing stations, and hygiene and menstrual health education. Receives: Other: Splash WASH in Schools programme (Project WISE) |
| Control | No intervention | Schools in the control group will receive no intervention during the study period (2021/2022 academic year), but will be on a waitlist to receive the Project WISE intervention after the end of the study period (2022/2023 academic year or later). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roll-call absence prevalence - Older children (7-16)
Attendance on the day of data collection will be recorded for all children in selected classes. This indicator is collected longitudinally over the course of the study at follow-up visits every 4-6 weeks.
Measured: Longitudinal: Every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
Self-reported absence prevalence - Older children (7-16)
All children present in selected classes will be asked to report full- and partial-day absence over the past week of school. This indicator is collected longitudinally over the course of the study at follow-up visits every 4-6 weeks.
Measured: Longitudinal: Baseline and every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
2- and 7-day period prevalence of diarrhoea - Older children (7-16)
All children present in selected classes will be asked whether they have had diarrhoea within the past 2 and 7 days. This indicator is collected longitudinally over the course of the study at follow-up visits every 4-6 weeks.
Measured: Longitudinal: Baseline and every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
2- and 7-day period prevalence of respiratory infection - Older children (7-16)
All children present in selected classes will be asked whether they have had specific symptoms of respiratory infection within the past 2 and 7 days. This indicator is collected longitudinally over the course of the study at follow-up visits every 4-6 weeks.
Measured: Longitudinal: Baseline and every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
Days with diarrhoea in past week - Kindergarten (4-6)
Parent-reported days with diarrhoea among kindergarten students with one-week recall period, assessed using telephone surveys. Cumulative days with diarrhoea over the four-week period will be calculated.
Measured: Longitudinal: Weekly for four weeks (February/March 2022).
Days with respiratory infection in past week - Kindergarten (4-6)
Parent-reported days with symptoms of respiratory infection among kindergarten students with one-week recall period, assessed using telephone surveys. Cumulative days with respiratory infection over the four-week period will be calculated.
Measured: Longitudinal: Weekly for four weeks (February/March 2022).
Absence in past week - Kindergarten (4-6)
Parent-reported days of absence from kindergarten with one-week recall period, assessed using telephone surveys. Cumulative absence over the four-week period will be calculated.
Measured: Longitudinal: Weekly for four weeks (February/March 2022).
Secondary outcomes (3)
Strengths and Difficulties Questionnaire (SDQ) total score - Older children (11-16)
Children aged 11 or older in selected classrooms will complete the self-rated SDQ (25 items) as a measure of wellbeing.
Measured: Final follow-up at 9 months (May 2022)
Self-Efficacy in Addressing Menstrual Needs Scale (SAMN-Scale) total score - Older children (10-16)
Post-menarcheal girls aged 10 or older present in selected classrooms will be asked to complete the SAMN-Scale questionnaire. SAMN-Scale measures respondents' perceived self-efficacy to address their menstrual needs.
Measured: Final follow-up at 9 months (May 2022)
Menstrual Practice Needs Scale (MPNS-36) total score - Older children (10-16)
Post-menarcheal girls aged 10 or older present in selected classrooms will be asked to complete the MPNS-36 questionnaire. MPNS-36 measures the extent to which respondents' menstrual management practices and environments were perceived to meet their needs during their last period.
Measured: Final follow-up at 9 months (May 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start2 Nov 2021
- Primary completion1 Jul 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- 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
- 7,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Investment Fund Foundation, Splash
- Responsible party
- Sponsor
- Investigators
- Robert Dreibelbis, PhD, Principal investigator, London School of Hygiene and Tropical MedicineOliver Cumming, MSc, Study director, London School of Hygiene and Tropical MedicineElizabeth Allen, PhD, Study director, London School of Hygiene and Tropical MedicineBaptiste Leurent, PhD, Study director, London School of Hygiene and Tropical MedicineSarah Bick, MSc, Study director, London School of Hygiene and Tropical MedicineAlem Ezezew, Study director, Holster International Research & Development Consultancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024890
- Sponsor's protocol ID
- 17761
- Acronym
- WISE
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bick S, Ezezew A, Opondo C, Leurent B, Argaw W, Hunter EC, Cumming O, Allen E, Dreibelbis R. Impact of a school-based water and hygiene intervention on child health and school attendance in Addis Ababa, Ethiopia: a cluster-randomised controlled trial. BMC Med. 2024 Sep 2;22(1):348. doi: 10.1186/s12916-024-03558-x.
PubMed 39218883
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WASH In Schools for Everyone (WISE): a Randomised Evaluation Assessing the Impact of a School-based Water, Sanitation and Hygiene (WASH) Intervention on Child Health and School Attendance in Addis Ababa, Ethiopia
- ClinicalTrials.gov ID
- NCT05024890
- Acronym / sponsor ID
- WISE / 17761
- Conditions
- Diarrhea, Respiratory Tract Infections, Absenteeism
- Keywords
- water, sanitation, hygiene, schoolchildren, WASH in schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,072 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Children's Investment Fund Foundation, Splash
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 27 Aug 2021 (actual)
- 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.
This study aims to assess the effects of school-based, comprehensive water, sanitation, and hygiene improvements on child health and educational outcomes in schools in Addis Ababa, Ethiopia. Eligible schools will be randomly allocated to intervention or control groups. Data on pupil absence and illness will be collected longitudinally from students in selected classrooms in each school over the course of one academic year (2021/2022). This study will also assess the effects of the intervention on kindergarten students through parent interviews.
Detailed description
This study uses a cluster-randomised controlled trial design to evaluate the impact of the WASH in Schools for Everyone (WISE) programme. Project WISE, implemented by Splash, aims to improve child health and attendance by 1) improving WASH infrastructure, 2) promoting WASH behaviour change and 3) strengthening menstrual hygiene management (MHM) services targeting girls aged 10 and above, in public schools across Addis Ababa.
60 public schools from planned implementation groups that will receive the WISE intervention will be randomised: 30 schools will be allocated to the intervention group (to receive the WISE intervention during the 2021/2022 academic year) and 30 schools will be allocated to the control group (on a waitlist to receive the WISE intervention after study completion). Randomisation will be stratified by school size (number of students) and presence of a kindergarten. In each selected school, between two and four classes will be randomly selected from grades 2-8 - to obtain a sample size of approximately 100 students in total per school. Students in the selected classes will be enrolled at the start of the academic year (September 2021) and followed up with unannounced visits every 4-6 weeks until the end of the academic year (May 2022). Primary outcomes of pupil-reported illness and absence will be assessed during enrolment and at each follow-up visit. Secondary outcomes are restricted to subsets of students by age and gender, and will be assessed during the final follow-up visit. Students joining the class mid-way through the year will be enrolled in the study, and students who leave the class will be recorded.
Key outcomes of interest are longitudinal prevalence of absence and illness (diarrhoea and respiratory infection) over the course of the academic year, measured as cumulative number of days absent/with illness per 100 school days after adjustment for child- and school-specific covariates. Data collected in intervention schools prior to and/or during the active Splash intervention will not be included in the primary impact evaluation analysis. Sub-population analysis of evaluation outcomes in girls post-menarche will allow assessment of the gendered effects of the intervention. We will also monitor intervention fidelity and compliance, as well as cost-effectiveness of the intervention, through routine data collection with students and school staff.
40 public schools with a kindergarten will be enrolled to assess the impacts of the intervention among kindergarten students (20 intervention, 20 control). Schools enrolled in the intervention and control arms of the main study among older children that have a kindergarten will be also enrolled in the kindergarten evaluation. If there are fewer than 20 such schools in each arm, additional kindergarten schools will be randomised (estimated 10 additional schools per arm). In each selected school, 20 kindergarten students will be randomly selected for participation. Parents of selected students will be invited to participate in weekly telephone surveys over a four-week period in February/March 2022 in order to assess the longitudinal prevalence of illness and absence among kindergarteners.
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 programme | Experimental | Other: Splash WASH in Schools programme (Project WISE)Schools in the intervention group will receive the Splash WASH in Schools programme (Project WISE) during the study period (2021/2022 academic year), including sanitation, water storage and filtration, drinking water and handwashing stations, and hygiene and menstrual health education. |
| Control | No intervention | –Schools in the control group will receive no intervention during the study period (2021/2022 academic year), but will be on a waitlist to receive the Project WISE intervention after the end of the study period (2022/2023 academic year or later). |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Splash WASH in Schools programme (Project WISE)The Project WISE intervention includes: WASH infrastructure * Water storage tanks and water filtration systems * Durable plastic drinking water and handwashing stations * New/rehabilitated toilet facilities (gender-segregated, wheelchair-accessible, well-lit, ventilated, durable door and lock) Behaviour change promotion * Training of focal teachers to organise student 'hygiene club' * Annual soap drive and soap restocking * Behavioural 'nudges' (posters and mirrors at handwashing stations, colourful vests for hygiene clubs) MHM services * Toilets have water tap, bucket and waste bin * Emergency menstrual hygiene products available at school * Training of focal teachers to organise student 'gender club' * Education on puberty and menstruation for all pupils above 10 and parent resource guide | Other | WASH in Schools programme |
Primary outcome
Roll-call absence prevalence - Older children (7-16)
Time frame: Longitudinal: Every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
Attendance on the day of data collection will be recorded for all children in selected classes. This indicator is collected longitudinally over the course of the study at follow-up visits every 4-6 weeks.
Self-reported absence prevalence - Older children (7-16)
Time frame: Longitudinal: Baseline and every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
All children present in selected classes will be asked to report full- and partial-day absence over the past week of school. This indicator is collected longitudinally over the course of the study at follow-up visits every 4-6 weeks.
2- and 7-day period prevalence of diarrhoea - Older children (7-16)
Time frame: Longitudinal: Baseline and every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
All children present in selected classes will be asked whether they have had diarrhoea within the past 2 and 7 days. This indicator is collected longitudinally over the course of the study at follow-up visits every 4-6 weeks.
2- and 7-day period prevalence of respiratory infection - Older children (7-16)
Time frame: Longitudinal: Baseline and every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
All children present in selected classes will be asked whether they have had specific symptoms of respiratory infection within the past 2 and 7 days. This indicator is collected longitudinally over the course of the study at follow-up visits every 4-6 weeks.
Days with diarrhoea in past week - Kindergarten (4-6)
Time frame: Longitudinal: Weekly for four weeks (February/March 2022).
Parent-reported days with diarrhoea among kindergarten students with one-week recall period, assessed using telephone surveys. Cumulative days with diarrhoea over the four-week period will be calculated.
Days with respiratory infection in past week - Kindergarten (4-6)
Time frame: Longitudinal: Weekly for four weeks (February/March 2022).
Parent-reported days with symptoms of respiratory infection among kindergarten students with one-week recall period, assessed using telephone surveys. Cumulative days with respiratory infection over the four-week period will be calculated.
Absence in past week - Kindergarten (4-6)
Time frame: Longitudinal: Weekly for four weeks (February/March 2022).
Parent-reported days of absence from kindergarten with one-week recall period, assessed using telephone surveys. Cumulative absence over the four-week period will be calculated.
3 secondary outcomes
Strengths and Difficulties Questionnaire (SDQ) total score - Older children (11-16)
Time frame: Final follow-up at 9 months (May 2022)
Self-Efficacy in Addressing Menstrual Needs Scale (SAMN-Scale) total score - Older children (10-16)
Time frame: Final follow-up at 9 months (May 2022)
Menstrual Practice Needs Scale (MPNS-36) total score - Older children (10-16)
Time frame: Final follow-up at 9 months (May 2022)
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 19 Aug 2022.
- Derived from this study: PubMed 39218883Bick S, Ezezew A, Opondo C, Leurent B, Argaw W, Hunter EC, Cumming O, Allen E, Dreibelbis R. Impact of a school-based water and hygiene intervention on child health and school attendance in Addis Ababa, Ethiopia: a cluster-randomised controlled trial. BMC Med. 2024 Sep 2;22(1):348. doi: 10.1186/s12916-024-03558-x.
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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.
Robert Dreibelbis, PhD principal investigator
London School of Hygiene and Tropical Medicine
Oliver Cumming, MSc study director
London School of Hygiene and Tropical Medicine
Elizabeth Allen, PhD study director
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splash WASH in Schools programme (Project WISE) in people with Diarrhea and Respiratory Tract Infections, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Roll-call absence prevalence - Older children (7-16) (time frame: Longitudinal: Every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)). The study lists 7 primary outcomes in all. 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 NCT05024890, which also lists 1 linked publication.
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 19 Aug 2022.