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

NCT ID: NCT03075436

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-07

Study Completion Date

2019-05-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sustained Behavior Change Mental Well-being

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Enhanced demand-side sanitation, hygiene

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Standard of care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory Ethiopia

UNKNOWN

Sponsor Role collaborator

Amhara Regional Health Bureau

UNKNOWN

Sponsor Role collaborator

Federal Democratic Republic of Ethiopia Ministry of Health

UNKNOWN

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Matthew Freeman, MPH, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Freeman, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Amhara

Amhara National Regional State, , Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type DERIVED
PMID: 36962125 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31226957 (View on PubMed)

Other Identifiers

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IRB00076141

Identifier Type: -

Identifier Source: org_study_id

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