The Impact of Enhanced, Demand-side Sanitation and Hygiene Promotion on Sustained Behavior Change and Health in Ethiopia

Mental Well-being Clinical Trial

Official title:

The Impact of Enhanced, Demand-side Sanitation and Hygiene Promotion on Sustained Behavior Change and Health in Ethiopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075436
• Other study ID #: IRB00076141
• Status: Completed
• Phase: N/A
• Start date: March 7, 2017
• Est. completion date: May 16, 2019

Study information

• Verified date: July 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a two-year evaluation investigating the impacts of an enhanced, demand-side sanitation and hygiene intervention on sustainable adoption of improved water, sanitation, and hygiene (WASH) practices and mental well-being.

Description:

This study utilizes a cluster randomized, controlled trial design to examine the impacts of an enhanced, demand-side sanitation and hygiene intervention on behavior change and health in Amhara, Ethiopia. The study will test hypotheses set out in the investigation team's theory of change through the measurement and evaluation of process indicators, intermediate and shorter-term behavioral outcomes, and longer-term behavioral and health impacts, including mental well-being.

The study aims to: (1) identify ways in which WASH-related behavior change components preventive for neglected tropical diseases (NTDs) can be mainstreamed into the government-led Health Extension Program; (2) document the effectiveness of an enhanced demand-side sanitation and hygiene intervention; (3) investigate whether changes in personal hygiene, sanitation, and water behaviors are sustained; (4) document the cost-effectiveness of integrated WASH-related NTD-preventive behavior change promotion; and (5) assess whether collective efficacy and water security modify intervention effectiveness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10375
• Est. completion date: May 16, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Households residing in kebeles in select woredas of Amhara National Regional State

• Households with at least one adult (18 years of age or older) who provides consent to serve as the survey respondent

• Households with at least one child aged 1-9 years (at baseline) living in the household and consenting to enrollment in the study, including study staff observation of children, specifically their faces and hands

Exclusion criteria:

• Households that refuse to provide consent to enroll in the study or have one adult consent to serve as the survey respondent

• Households that are repeatedly vacant or do not have an appropriate member of the household home to serve as the household's respondent (capable adult 18 years or older) after three attempts within the course of one day (for study enrollment and baseline)

• Households that do not have a household member aged 0-5 years of age (at baseline) living in the household

Related Conditions & MeSH terms

• Mental Well-being
• Sustained Behavior Change

Intervention

Behavioral:
• Enhanced demand-side sanitation, hygiene
The enhanced, demand-side sanitation and hygiene intervention package will be informed by findings from formative research, and will consist of interventions designed to enhance sanitation and hygiene messaging to better facilitate behavior change, and intensify implementation of related community-based interventions via engagement of various delivery modalities.
• Standard of care
The comparison group will receive the current standard of care, including potential implementation of government-led policies and programs.

Locations

Country	Name	City	State
Ethiopia	Amhara	Amhara National Regional State

Sponsors (4)

Lead Sponsor	Collaborator
Emory University	Amhara Regional Health Bureau, Emory Ethiopia, Federal Democratic Republic of Ethiopia Ministry of Health

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustainability of WASH-related behaviours, including NTD-preventive WASH behavior measures	Sustainability of WASH-related behaviors, as measured through changes in the proportion of individuals and households practicing targeted improved NTD-preventive WASH behaviors.	Endline (Up to two years)
Primary	Mental well-being measures	Mental well-being, as measured through the changes in mental well-being scale scores	Up to two years
Secondary	Shorter-term behavioral outcome measures	Proportion of households with improved or shared, but otherwise improved household latrine and washing facilities that are functional and available for use; proportion of households using functional latrines and washing facilities; proportion of households with all members exclusively using a latrine for defecation purposes; proportion of households disposing of child feces in an improved latrine; proportion of households with all children in the household with a clean face and hands.	Up to two years
Secondary	Intermediate behaviour change antecedent measures	Proportion of households with improved knowledge regarding the implications of improved WASH practices; proportion of households that indicate positive attitudes, perceptions toward improved sanitation and good hygiene practices; change in normative beliefs and behaviors related to open defecation, exclusive latrine use for defecation, and personal hygiene practices.	Up to two years
Secondary	Water insecurity measures	Water insecurity, as measured through changes in water insecurity scale scores	Up to two years
Secondary	Sanitation insecurity measures	Sanitation insecurity, as measured through changes in sanitation insecurity scale scores	Up to two years
Secondary	Collective efficacy measures	Collective efficacy, as measured through changes in collective efficacy scale scores	Up to two years