- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05808218
WASH For Everyone: Testing Alternative Approaches to Sanitation and Hygiene Behaviour Change in Chiradzulu, Malawi (W4E)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clara Macleod, MSc
- Phone Number: +44 (0)20 7636 8636
- Email: Clara.Macleod@lshtm.ac.uk
Study Contact Backup
- Name: Kondwani Chidziwisano, PhD
- Phone Number: +265 888 38 49 65
- Email: kchidziwisano@mubas.ac.mw
Study Locations
-
-
-
Blantyre, Malawi
- Recruiting
- Malawi University of Business and Applied Sciences, WASHTED Centre
-
Contact:
- Kondwani Chidziwisano, PhD
- Phone Number: +265 888 38 49 65
- Email: kchidziwisano@mubas.ac.mw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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:
In addition to the activities above, the WASH for Everyone team will:
Other Names:
|
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:
In addition to the activities above, the WASH for Everyone team will:
Other Names:
|
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
Collaborators
Investigators
- Principal Investigator: Robert Dreibelbis, PhD, London School of Hygiene and Tropical Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 28249
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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