Clinical trial NCT05024890: The Impact of a School-based WASH Intervention on Child Health and School Attendance in Addis Ababa, Ethiopia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Respiratory Tract Infections
Absenteeism
Keywords: water
sanitation
hygiene
schoolchildren
WASH in schools
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Children's Investment Fund Foundation
name: Splash
First posted: 2021-08-27
Enrollment: 7072
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Roll-call absence prevalence - Older children (7-16)
timeFrame: Longitudinal: Every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
measure: Self-reported absence prevalence - Older children (7-16)
timeFrame: Longitudinal: Baseline and every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
measure: 2- and 7-day period prevalence of diarrhoea - Older children (7-16)
timeFrame: Longitudinal: Baseline and every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
measure: 2- and 7-day period prevalence of respiratory infection - Older children (7-16)
timeFrame: Longitudinal: Baseline and every 4-6 weeks. Participants will be followed for 9 months (September 2021-May 2022)
measure: Days with diarrhoea in past week - Kindergarten (4-6)
timeFrame: Longitudinal: Weekly for four weeks (February/March 2022).
measure: Days with respiratory infection in past week - Kindergarten (4-6)
timeFrame: Longitudinal: Weekly for four weeks (February/March 2022).
measure: Absence in past week - Kindergarten (4-6)
timeFrame: Longitudinal: Weekly for four weeks (February/March 2022).
Secondary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ) total score - Older children (11-16)
timeFrame: Final follow-up at 9 months (May 2022)
measure: Self-Efficacy in Addressing Menstrual Needs Scale (SAMN-Scale) total score - Older children (10-16)
timeFrame: Final follow-up at 9 months (May 2022)
measure: Menstrual Practice Needs Scale (MPNS-36) total score - Older children (10-16)
timeFrame: Final follow-up at 9 months (May 2022)
Other outcomes:
measure: Gender parity in school enrolment using the adjusted gender parity index (aGPI)
timeFrame: Baseline (September 2021) and end-of-year at 9 months (May 2022)
measure: Subjective wellbeing using smiley faces visual analogue scale - Older children (7-16)
timeFrame: Final follow-up at 9 months (May 2022)
measure: Sanitation-related quality of life (SanQoL) total score - Older children (7-16)
timeFrame: Final follow-up at 9 months (May 2022)
Locations:
city: Addis Ababa
country: Ethiopia
facility: Holster International Research and Development Consultancy
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Robert Dreibelbis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Oliver Cumming, MSc
role: STUDY_DIRECTOR
affiliation: London School of Hygiene and Tropical Medicine
name: Elizabeth Allen, PhD
role: STUDY_DIRECTOR
affiliation: London School of Hygiene and Tropical Medicine
name: Baptiste Leurent, PhD
role: STUDY_DIRECTOR
affiliation: London School of Hygiene and Tropical Medicine
name: Sarah Bick, MSc
role: STUDY_DIRECTOR
affiliation: Holster International Research & Development Consultancy
name: Alem Ezezew
role: STUDY_DIRECTOR
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