The Water, Sanitation, and Hygiene (WASH) for Everyone controlled before-and-after (CBA) trial: trial protocol and baseline results

Background:

Community-based behaviour change interventions are a common approach to Water, Sanitation, and Hygiene (WASH). Yet, published evaluations of how these interventions work in district-wide approaches are rare.

Objective:

The aim of this study is to assess the effectiveness of a district-level Community-led Total Sanitation (CLTS) intervention compared to the additional integration of local Care Groups on sanitation coverage and use and hygiene behaviours in Chiradzulu District, Malawi.

Methods:

This study is a controlled before-and-after trial with two treatment arms and a control group. Clusters are rural villages in three Traditional Authorities (TAs). One arm receives CLTS and the Care Group Model, one arm receives CLTS only, and one serves as the control group. The trial is part of the wider WASH for Everyone (W4E) project, led by World Vision Malawi which aims to expand access to WASH services across the entire district by 2025. Study participants were selected from the three TAs. Systematic sampling procedures were used to select 20 households per cluster with a total of 1,400 households at both baseline and endline. The primary outcome is sanitation coverage. Secondary outcome measures include sanitation use, safe disposal of child faeces, observed handwashing facility, and Sanitation-related Quality of Life index (SanQoL-5).

Results:

Data collection was completed in April 2024 and the development of data analysis plan has been completed in October 2024 with analysis of data to be conducted between November to December 2024. Baseline results show a no difference for primary and secondary outcomes between arms. We noted low coverage of handwashing facilities with soap and water in all the three arms (i.e., CLTS only = 7%; CLTS and Care Groups = 4%; and control = 10%). Further, there was a slight variation (p= .08) in handwashing practice and sanitation coverage among the study arms.

Conclusions:

The baseline observations indicate a balanced distribution of potential demographic confounders in the trial arms. The trial intervention has been completed, and the evaluation report is expected to be published in 2025. Clinical Trial: The study protocol, which includes data collection tools, participant information sheets and consent forms, have been approved by the National Commission for Science and Technology (P01/23/718) in Malawi. The study was registered with clinicaltrials.gov (NCT05808218).