Hands4Health: A Multi-component Intervention on Hand Hygiene & Well-being in Schools in Nigeria & Palestine (H4H)

NCT05964478 | Completed

• 1 other identifier: 7F-l 0345.03.01A
• Study Type: interventional
• Target: 2,600
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim of this study is to assess the impact of the hands4health hand hygiene multi-component intervention on students and teachers in primary schools with limited access to water in Nigeria and Palestine. To evaluate the effects of the intervention, the investigators will involve the participants in the included schools in the following data collection methods, including (i) a survey regarding their thoughts, behaviours, and practices related to handwashing at school, (ii) structured observation of their handwashing behaviour (iii) hand rinse sample collection to check for bacteria on their hands, (iv) absenteeism tracking through a daily journal to record the reasons for any absences, with a specific focus on identifying if they are related to hygiene-related diseases, and (v) discussions and interviews to gather their perspectives on the perceived impacts of the intervention on their health and well-being. The investigators will collect data using these methods before the intervention starts, a few months after it begins, and again one year later. The schools will be randomly divided into two groups: one group will receive the intervention activities, including handwashing station/rehabilitation of water, sanitation and hygiene infrastructure, behavioural change intervention, capacity development, and management support. The other group will not receive any intervention until the end of the study. By comparing the two groups, the investigators will determine if the intervention had any impact on health determinants including, hygiene infrastructure, handwashing knowledge, behaviour, beliefs, etc.

Conditions

Hand Hygiene; Handwashing Behaviour; Well-Being

Keywords

Behaviour Change; WASH Infrastructure; Handwashing Station; Handwashing; Students; Primary Schools; Humanitarian

Outcome Measures

Primary Outcomes (1)

• Number of participants who wash their hands with water and soap before eating in the school

  The primary outcome of the study aims to assess the occurrence, frequency, and technique of participants' handwashing practice with water and soap before eating in the school. This assessment will be conducted through structured observations taking place over a 3-hour period on a single day.

  Up to 12 months

Secondary Outcomes (11)

• Number of participants who wash their hands with water and soap after using the toilet in the school

  Up to 12 months

• Change in self-reported handwashing practice

  Up to 12 months

• Change in self-reported well-being

  Up to 12 months

• Change in the log-transformed number of total coliforms and E.coli CFUs on the hands of participants

  Up to 12 months

• The cumulative count of school absences attributed to hygiene-related illnesses

  Up to 8 months

Other Outcomes (5)

• Covariate 1: Age

  Up to 12 months

• Covariate 2: Education

  Up to 12 months

• Covariate 3: Sex

  Up to 12 months

Study Arms (2)

Intervention arm of schools in Nigeria and Palestine

EXPERIMENTAL

The participating schools in this arm will receive the multi-component hand hygiene intervention package for a duration of one year

Other: Multi-component hand hygiene intervention in primary schools not connected to functional water supply system in Nigeria and Palestine

Control arm of schools in Nigeria and Palestine

NO INTERVENTION

The participating schools in this arm will not receive the multi-component hand hygiene intervention package until the conclusion of the study, which occurs one year after the completion of data collection at the endline assessment

Interventions

Multi-component hand hygiene intervention in primary schools not connected to functional water supply system in Nigeria and Palestine OTHER

Each participating school receives: (i) Two Gravit'eau handwashing stations (http://www.graviteau.ch): these systems recycle on-site greywater and operate through gravity and a manual foot pump, and can be produced locally. (ii) Behavior change activities: Developed by a group of expert psychologists (http://www.ranasmosler.com/ranas), utilizing the risks, attitudes, norms, abilities, and self-regulation (RANAS) approach. (iii) WASH infrastructure rehabilitation and soap dispenser installation. (iv) Controlled chlorine monitoring: Equipment provided for monitoring chlorine concentration in water storage, with staff training. (v) Preventive maintenance: Trained circuit rider inspects infrastructure regularly under WASH committee supervision

Also known as: Gravit'eau handwashing system, RANAS4schools, Chlorination support, Preventive maintenance

Intervention arm of schools in Nigeria and Palestine

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary school students aged 10-12 years attending included schools
• Students must be in the same school for the course of the study (1 year).
• \- Students of the classes included in the study in each included school in Palestine
• Students of the intervention schools
• Students need to represent each included class in the intervention.
• The teachers invited to participate in the FGDs should be
• Aged ≥ 18 years old
• Permanent employees in the school
• Teaching one of the classes included in the intervention
• The participant needs to be:
• a stakeholder within the community, state, or region of the intervention whose position is related in any way to WASH in schools
• working in one of the intervention schools. They can be hygiene technicians, teachers, school's principal, or in a leading position in the school.
• Aged ≥ 18 years old

You may not qualify if:

• Refusal to participate by not providing signed consent and assent forms
• Having any medical condition that prevents them from washing their hands
• Having unexplained intermittent attendance in school (school teachers will be consulted and the school's absenteeism records will be checked for that)
• Not being at the same school for the course of the study (1 year)

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• University of Applied Sciences and Arts Northwestern Switzerland: collaborator
• Terre des Hommes: collaborator
• CESVI: collaborator

Study Sites (2)

26 Primary Schools

Maiduguri, Borno State, Nigeria

Location

26 Primary Schools

Hebron, Palestinian Territories

Location

Related Publications (1)

• Galli A, Ma'ani Abuzahra Y, Banziger C, Ballo A, Friedrich MND, Gross K, Harter M, Hattendorf J, Peter M, Tamas A, Owen BN, Winkler MS. Assessing the Effectiveness of a Multicomponent Intervention on Hand Hygiene and Well-Being in Primary Health Care Centers and Schools Lacking Functional Water Supply in Protracted Conflict Settings: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 3;13:e52959. doi: 10.2196/52959.

  PMID: 38569182 DERIVED

Related Links

• Hands4health project website
• Gravit'eau handwashing system website
• RANAS Ltd. website

Study Officials

• Mirko S. Winler, Prof.

  wiss Tropical and Public Health Institute and University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The laboratory technicians involved in the processing and analysis of the hand rinse samples will be masked and therefore do not know if the sample comes from the intervention or the control group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a multi-center Cluster Randomised Controlled Trial being conducted across two countries. Within each country, there will be two arms: an intervention arm and a control arm. The intervention arm will receive a comprehensive multi-component intervention package. On the other hand, the control arm will not receive the intervention package during the data collection phase, serving as a comparison group. However, It will receive the same intervention package (with potential improvements) once the data collection period concludes, specifically at the endline assessment after one year from the baseline

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 28, 2023
• Study Start: June 29, 2023
• Primary Completion: June 26, 2024
• Study Completion: August 16, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Our partners in Nigeria (Tdh) and Palestine (Cesvi) have direct access to the individual participant data (IPD) as they collect and perform quality control on the data in the field. Other consortium members can request access to the IPD once the data collection is complete and it has been cleaned.
• Access Criteria: Within the consortium: Data gathered using ODK or KoboToolbox is stored on the ODK central server. The data collecting organizations (Tdh, CESVI), RANAS, and Swiss TPH have direct access to this server. Consortium members who require access to the data can contact someone with server access to request the coded data. Outside the consortium: Written approval from all consortium members is necessary for third parties to use the data.

Locations

PA (1); NG (1)