WASH For Everyone: Testing Alternative Approaches to Sanitation and Hygiene Behaviour Change in Chiradzulu, Malawi (W4E)

This study aims to assess the impact of multiple community-based behaviour change approaches on sanitation and hygiene behaviours in rural Malawi. Three different sub-districts (Traditional Authorities) in Chiradzulu District will be selected, each receiving a different combination of community-based interventions or will serve as controls. Eligible communities, households, and individuals will be randomly selected in each Traditional Authority and sanitation and hygiene behaviours assessed through self-report and direct observation after 1 year of intervention.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a controlled before-and-after study that will evaluate the impact on sanitation and hygiene behaviours of different community-based interventions implemented as part of the WASH For Everyone programme. WASH for Everyone, implemented by World Vision and Water For People. WASH for Everyone is a 3-year project (2022 - 2024) that aims to achieve universal access to water, sanitation, and hygiene (WASH) in Chiradzulu district, and promote improved sanitation and hygiene behaviours. There are two primary community-based sanitation and hygiene behaviour change approaches included in the WASH for Everyone interventions: 1) community-led total sanitation (CLTS), a widely implemented participatory approach to ending open defecation at the community-level and 2) Care Groups, a model using locally-based volunteer groups to implement peer-to-peer counselling and support with a long history in nutrition programming.

For the purposes of this study, one Traditional Authority will receive the CLTS intervention. A second Traditional Authority will receive the CLTS intervention with the additional of village-level Care Groups (CLTS +). A third traditional authority will serve as the comparison group.

Within study Traditional Authorities, communities will be selected at random for inclusion in the study. Twenty communities will be enrolled in both the CLTS and the CLTS+ Traditional Authorities. Thirty communities will be enrolled from the comparison Traditional Authority. In each selected community, an average of 20 households will be enrolled at baseline and again at endline. Difference-in-difference analysis will be used to measure the changes in primary and secondary outcomes between either intervention and control and between the two intervention groups.

Study Type

Interventional

Enrollment (Anticipated)

2800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Blantyre, Malawi
        • Recruiting
        • Malawi University of Business and Applied Sciences, WASHTED Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Households are primary sampling unit. Household eligibility requirements are:

Inclusion Criteria:

  • Presence of an adult head of household age 18 or over who gives consent for the household to participate in the study; household is permanent resident of selected village

Exclusion Criteria:

  • No permanent resident aged 18 or over; temporary resident of community/households

In selected households, 1 individual will be selected at random to complete study survey. Individual eligibility requirements are:

Inclusion criteria:

  • Permanent resident of selected household; able to provide informed consent

Exclusion criteria:

  • Not a permanent resident of selected household, not able to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: CLTS
This arm will receive a standard community-led total sanitation) intervention).

The community-led total sanitation intervention is implemented across an entire Traditional Authority and includes the following village-level activities:

  1. Triggering:

    • Village transect walks and open defecation site mapping
    • Demonstrations of food contamination and medical expense calculations
  2. Development of a Community-Action Plan and identification of "natural leaders"
  3. Post-triggering: routine follow-up by selected natural leaders to track and monitor progress against the Community Action Plan

In addition to the activities above, the WASH for Everyone team will:

  • Train a cadre of local masons on sanitation construction
  • Support the District Health office in the implementation of existing sanitation and hygiene promotion at village markets and other public spaces
Other Names:
  • CLTS
Experimental: CLTS Plus
Includes all activities in the CLTS arm with the addition of village-level Care Groups for sanitation and hygiene promotion.

The community-led total sanitation intervention is implemented across an entire Traditional Authority and includes the following village-level activities:

  1. Triggering:

    • Village transect walks and open defecation site mapping
    • Demonstrations of food contamination and medical expense calculations
  2. Development of a Community-Action Plan and identification of "natural leaders"
  3. Post-triggering: routine follow-up by selected natural leaders to track and monitor progress against the Community Action Plan

In addition to the activities above, the WASH for Everyone team will:

  • Train a cadre of local masons on sanitation construction
  • Support the District Health office in the implementation of existing sanitation and hygiene promotion at village markets and other public spaces
Other Names:
  • CLTS
  • Orientation and training of village-level Care Group members on CLTS, latrine construction, and hygiene promotion
  • Routine house-to-house follow-up of Care Group members to provide peer-to-peer counselling and support on sanitation and hygiene behaviours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sanitation coverage
Time Frame: study endline (one year)
Sanitation coverage is defined as confirmed presence of a functional sanitation facility in the home or compound that meets standard definitions of at least unimproved sanitation facilities according to the Joint Monitoring Programme. This will be determined by reported access to a private, household sanitation facility that respondents self-identify as completed. Self-reported access will be verified through visual inspection of the sanitation facilities.
study endline (one year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sanitation use
Time Frame: study endline (one year)
Self-reported exclusive use of a sanitation facility for defecation among all members of a select households
study endline (one year)
safe disposal of child feces
Time Frame: study endline (one year)
Self-reported disposal of feces of any child under the age of five in a latrine / toilet
study endline (one year)
handwashing facility
Time Frame: study endline (one year)
presence of a dedicated device / location in the household were both soap and water are available for handwashing
study endline (one year)
Basic sanitation coverage
Time Frame: study endline (one year)
coverage: basic sanitation coverage is defined as the presence of a completed sanitation facility at the home that meets the minimum criteria of a basic sanitation facility, i.e. improved facility not shared with other households
study endline (one year)
Handwashing behaviour
Time Frame: study endline (one year)
observed handwashing with soap at critical moments (after defecation, cleaning a child and before cooking, eating, or feeding a child); measured through a three-hour direct observation in 50% of all study participants
study endline (one year)
Sanitation-related Quality-of-Life Index
Time Frame: study endline (one year)
Sanitation-related Quality of Life (SANQOL) is a five-question instrument for measuring the degree of achievement of the following sanitation-related capabilities: privacy, safety, health, shame and disgust. Scores range from 0 to 1 with higher scores indicating a higher sanitation-related quality of life.
study endline (one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Dreibelbis, PhD, London School of Hygiene and Tropical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2023

Primary Completion (Anticipated)

April 27, 2024

Study Completion (Anticipated)

April 27, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 28249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be fully anonymised and posted on a public repository for third party use. To completely anonymise the data prior to uploading it onto an open data site, any references to specific places, information about occupation, and any other information that holds the potential to identify the respondents will be redacted. Public repository will be determined in collaboration with study partners and project funders.

IPD Sharing Time Frame

Data will be made available within 1 year of final data collection

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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