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BehaviorW4ENCT05808218

WASH for Everyone: Testing Alternative Approaches to Sanitation and Hygiene Behaviour Change in Chiradzulu, Malawi

A study testing Community-Led Total Sanitation and Care Groups in people with Behavior, run by London School of Hygiene and Tropical Medicine at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Behavior
What is being tested?
Community-Led Total Sanitation and Care Groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,800 participants
Where
1 siteMalawi
Study dates
13 Apr 2023to 1 May 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malawi1 site

  • Malawi University of Business and Applied Sciences, WASHTED Centre

    Blantyre

Other trials in Malawi

About this study

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.

Read the 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.

Conditions
Behavior
Being tested
Community-Led Total Sanitation, Care Groups
Keywords
sanitation, handwashing, hygiene
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community-Led Total SanitationOther

    Also called CLTS

    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
    1. Development of a Community-Action Plan and identification of "natural leaders"
    2. 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

  • Care GroupsOther

    • 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.
Study groups in NCT05808218
Study groupRoleWhat they receive
CLTSExperimentalThis arm will receive a standard community-led total sanitation) intervention).
Receives: Other: Community-Led Total Sanitation
CLTS PlusExperimentalIncludes all activities in the CLTS arm with the addition of village-level Care Groups for sanitation and hygiene promotion.
Receives: Other: Community-Led Total Sanitation; Other: Care Groups
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sanitation coverage

    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.

    Measured: study endline (one year)

Secondary outcomes (6)

  1. sanitation use

    Self-reported exclusive use of a sanitation facility for defecation among all members of a select households

    Measured: study endline (one year)

  2. safe disposal of child feces

    Self-reported disposal of feces of any child under the age of five in a latrine / toilet

    Measured: study endline (one year)

  3. handwashing facility

    presence of a dedicated device / location in the household were both soap and water are available for handwashing

    Measured: study endline (one year)

  4. Basic sanitation coverage

    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

    Measured: study endline (one year)

  5. Sanitation-related Quality-of-Life Index

    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.

    Measured: study endline (one year)

  6. Handwashing behaviour

    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

    Measured: study endline (one year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study start13 Apr 2023
  3. Primary completion1 May 2024
  4. Study completion1 May 2024

Resources

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
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05808218
Sponsor's protocol ID
28249
Acronym
W4E
Status last verified
Oct 2024
First submitted
29 Mar 2023
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Chidziwisano K, Panulo M, MacLeod C, Vigneri M, White B, Wells J, Ross I, Morse T, Dreibelbis R. Water, Sanitation, and Hygiene for Everyone Intervention Study: Protocol for a Controlled Before-and-After Trial. JMIR Res Protoc. 2025 May 15;14:e68280. doi: 10.2196/68280.

    PubMed 40373302

Questions about this trial

What is this clinical trial studying?

A study testing Community-Led Total Sanitation and Care Groups in people with Behavior, run by London School of Hygiene and Tropical Medicine at 1 site in Malawi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. 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 7 Mar 2025. 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 Malawi. 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?

sanitation coverage (time frame: study endline (one year)). 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 NCT05808218, 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 7 Mar 2025.

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