NCT05024890

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,072

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

August 23, 2021

Last Update Submit

August 18, 2022

Conditions

Keywords

watersanitationhygieneschoolchildrenWASH in schools

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    Longitudinal: Weekly for four weeks (February/March 2022).

Secondary Outcomes (3)

  • Strengths and Difficulties Questionnaire (SDQ) total score - Older children (11-16)

    Final follow-up at 9 months (May 2022)

  • Self-Efficacy in Addressing Menstrual Needs Scale (SAMN-Scale) total score - Older children (10-16)

    Final follow-up at 9 months (May 2022)

  • Menstrual Practice Needs Scale (MPNS-36) total score - Older children (10-16)

    Final follow-up at 9 months (May 2022)

Other Outcomes (3)

  • Gender parity in school enrolment using the adjusted gender parity index (aGPI)

    Baseline (September 2021) and end-of-year at 9 months (May 2022)

  • Subjective wellbeing using smiley faces visual analogue scale - Older children (7-16)

    Final follow-up at 9 months (May 2022)

  • Sanitation-related quality of life (SanQoL) total score - Older children (7-16)

    Final follow-up at 9 months (May 2022)

Study Arms (2)

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.

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).

Interventions

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

WASH in Schools programme

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • School is part of Splash Project WISE implementation groups
  • School agrees to participate in the research

You may not qualify if:

  • 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 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 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 is part of Splash Project WISE implementation groups
  • School has a kindergarten
  • School agrees to participate in the research
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holster International Research and Development Consultancy

Addis Ababa, Ethiopia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DiarrheaRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsRespiratory Tract Diseases

Study Officials

  • Robert Dreibelbis, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR
  • Oliver Cumming, MSc

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR
  • Elizabeth Allen, PhD

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR
  • Baptiste Leurent, PhD

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR
  • Sarah Bick, MSc

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR
  • Alem Ezezew

    Holster International Research & Development Consultancy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 27, 2021

Study Start

November 2, 2021

Primary Completion

July 1, 2022

Study Completion

August 10, 2022

Last Updated

August 19, 2022

Record last verified: 2021-08

Locations