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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05808218
Other study ID # 28249
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 13, 2023
Est. completion date April 27, 2024

Study information

Verified date March 2023
Source London School of Hygiene and Tropical Medicine
Contact Clara Macleod, MSc
Phone +44 (0)20 7636 8636
Email Clara.Macleod@lshtm.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2800
Est. completion date April 27, 2024
Est. primary completion date April 27, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Community-Led Total Sanitation
The community-led total sanitation intervention is implemented across an entire Traditional Authority and includes the following village-level activities: Triggering: Village transect walks and open defecation site mapping Demonstrations of food contamination and medical expense calculations Development of a Community-Action Plan and identification of "natural leaders" 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 Groups
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.

Locations

Country Name City State
Malawi Malawi University of Business and Applied Sciences, WASHTED Centre Blantyre

Sponsors (3)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Malawi University of Business and Applied Sciences (MUBAS) WASHTED Centre, University of Strathclyde

Country where clinical trial is conducted

Malawi, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 sanitation use Self-reported exclusive use of a sanitation facility for defecation among all members of a select households study endline (one year)
Secondary safe disposal of child feces Self-reported disposal of feces of any child under the age of five in a latrine / toilet study endline (one year)
Secondary handwashing facility presence of a dedicated device / location in the household were both soap and water are available for handwashing study endline (one year)
Secondary 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 study endline (one year)
Secondary 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. study endline (one year)
Secondary 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 study endline (one year)
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