NCT03075436

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,375

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2.2 years

First QC Date

March 7, 2017

Last Update Submit

July 2, 2019

Conditions

Keywords

SanitationHygienePublic HealthBehavior changeNeglected tropical diseasesDemand-side sanitation and hygieneMental well-beingWater insecuritySanitation insecurityCollective efficacy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Shorter-term behavioral outcome measures

    Up to two years

  • Intermediate behaviour change antecedent measures

    Up to two years

  • Water insecurity measures

    Up to two years

  • Sanitation insecurity measures

    Up to two years

  • Collective efficacy measures

    Up to two years

Study Arms (2)

Enhanced demand-side sanitation, hygiene

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

The comparison group will receive the current standard of care, including potential implementation of government-led policies and programs.

Behavioral: Standard of care

Interventions

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.

Enhanced demand-side sanitation, hygiene

The comparison group will receive the current standard of care, including potential implementation of government-led policies and programs.

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amhara

Amhara National Regional State, Ethiopia

Location

Related Publications (2)

  • Freeman MC, Delea MG, Snyder JS, Garn JV, Belew M, Caruso BA, Clasen TF, Sclar GD, Tesfaye Y, Woreta M, Zewudie K, Gobezayehu AG. The impact of a demand-side sanitation and hygiene promotion intervention on sustained behavior change and health in Amhara, Ethiopia: A cluster-randomized trial. PLOS Glob Public Health. 2022 Jan 7;2(1):e0000056. doi: 10.1371/journal.pgph.0000056. eCollection 2022.

  • 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.

MeSH Terms

Conditions

Psychological Well-BeingNeglected Diseases

Interventions

HygieneStandard of Care

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPublic HealthEnvironment and Public HealthQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Matthew Freeman, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 9, 2017

Study Start

March 7, 2017

Primary Completion

May 16, 2019

Study Completion

May 16, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations