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Completed

NCT Number: NCT03075436

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amhara

Amhara National Regional State, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced demand-side sanitation, hygiene

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

Behavioral

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

Primary outcomes

  1. Sustainability of WASH-related behaviours, including NTD-preventive WASH behavior measures

    Time frame: Endline (Up to two years)

    Sustainability of WASH-related behaviors, as measured through changes in the proportion of individuals and households practicing targeted improved NTD-preventive WASH behaviors.

  2. Mental well-being measures

    Time frame: Up to two years

    Mental well-being, as measured through the changes in mental well-being scale scores

Secondary outcomes

  1. Shorter-term behavioral outcome measures

    Time frame: Up to two years

    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.

  2. Intermediate behaviour change antecedent measures

    Time frame: Up to two years

    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.

  3. Water insecurity measures

    Time frame: Up to two years

    Water insecurity, as measured through changes in water insecurity scale scores

  4. Sanitation insecurity measures

    Time frame: Up to two years

    Sanitation insecurity, as measured through changes in sanitation insecurity scale scores

  5. Collective efficacy measures

    Time frame: Up to two years

    Collective efficacy, as measured through changes in collective efficacy scale scores

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Amhara Regional Health Bureau
  • Emory Ethiopia
  • Ministry of Health, Ethiopia

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2017
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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