NCT05808218

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 7, 2025

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

March 29, 2023

Last Update Submit

March 4, 2025

Conditions

Keywords

sanitationhandwashinghygiene

Outcome Measures

Primary Outcomes (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.

    study endline (one year)

Secondary Outcomes (6)

  • sanitation use

    study endline (one year)

  • safe disposal of child feces

    study endline (one year)

  • handwashing facility

    study endline (one year)

  • Basic sanitation coverage

    study endline (one year)

  • Sanitation-related Quality-of-Life Index

    study endline (one year)

  • +1 more secondary outcomes

Study Arms (3)

CLTS

EXPERIMENTAL

This arm will receive a standard community-led total sanitation) intervention).

Other: Community-Led Total Sanitation

CLTS Plus

EXPERIMENTAL

Includes all activities in the CLTS arm with the addition of village-level Care Groups for sanitation and hygiene promotion.

Other: Community-Led Total SanitationOther: Care Groups

Control

NO INTERVENTION

Interventions

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

Also known as: CLTS
CLTSCLTS Plus

* 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.

CLTS Plus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malawi University of Business and Applied Sciences, WASHTED Centre

Blantyre, Malawi

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Behavior

Study Officials

  • Robert Dreibelbis, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 11, 2023

Study Start

April 13, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

March 7, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Data will be made available within 1 year of final data collection

Locations