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

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.

Study Overview

• Status: Completed
• Conditions: Mental Well-being; Sustained Behavior Change
• Intervention / Treatment: Behavioral: Enhanced demand-side sanitation, hygiene; Behavioral: Standard of care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Amhara National Regional State, Ethiopia
    • Amhara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced demand-side sanitation, hygiene; The intervention group will receive a package of enhanced, demand-side sanitation and hygiene interventions that are informed by formative research and facilitated by local government and Emory Ethiopia partners.	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.
Active Comparator: Standard of care; The comparison group will receive the current standard of care, including potential implementation of government-led policies and programs.	Behavioral: Standard of care; The comparison group will receive the current standard of care, including potential implementation of government-led policies and programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Mental well-being measures	Mental well-being, as measured through the changes in mental well-being scale scores	Up to two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Water insecurity measures	Water insecurity, as measured through changes in water insecurity scale scores	Up to two years
Sanitation insecurity measures	Sanitation insecurity, as measured through changes in sanitation insecurity scale scores	Up to two years
Collective efficacy measures	Collective efficacy, as measured through changes in collective efficacy scale scores	Up to two years

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Emory Ethiopia; Amhara Regional Health Bureau; Federal Democratic Republic of Ethiopia Ministry of Health
• Investigators: Principal Investigator: Matthew Freeman, PhD, Emory University

Publications and helpful links

General Publications

• Delea MG, Snyder JS, Belew M, Caruso BA, Garn JV, Sclar GD, Woreta M, Zewudie K, Gebremariam A, Freeman MC. Design of a parallel cluster-randomized trial assessing the impact of a demand-side sanitation and hygiene intervention on sustained behavior change and mental well-being in rural and peri-urban Amhara, Ethiopia: Andilaye study protocol. BMC Public Health. 2019 Jun 21;19(1):801. doi: 10.1186/s12889-019-7040-6.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Actual): May 16, 2019
• Study Completion (Actual): May 16, 2019

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Mental well-being; Public Health; Behavior change; Hygiene; Neglected tropical diseases; Sanitation; Demand-side sanitation and hygiene; Water insecurity; Sanitation insecurity; Collective efficacy
• Other Study ID Numbers: IRB00076141

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No