Sustained Behavior ChangeNCT03075436

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

A study testing Enhanced demand-side sanitation, hygiene in people with Sustained Behavior Change and Mental Well-being, run by Emory University at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Sustained Behavior Change, Mental Well-being
What is being tested?: Enhanced demand-side sanitation, hygiene
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10,375 participants
Where: 1 siteEthiopia
Study dates: 7 Mar 2017to 16 May 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

Amhara
Amhara National Regional State

Other trials in Ethiopia

About this study

Read the 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.

Conditions: Sustained Behavior Change, Mental Well-being
Being tested: Enhanced demand-side sanitation, hygiene, Standard of care
Keywords: Sanitation, Hygiene, Public Health, Behavior change, Neglected tropical diseases, Demand-side sanitation and hygiene, Mental well-being, Water insecurity, Sanitation insecurity, Collective efficacy
Medical subject headings: Psychological Well-Being, Neglected Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced demand-side sanitation, hygieneBehavioural
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 careBehavioural
The comparison group will receive the current standard of care, including potential implementation of government-led policies and programs.

Study groups in NCT03075436
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Endline (Up to two years)
Mental well-being measures
Mental well-being, as measured through the changes in mental well-being scale scores
Measured: Up to two years

Secondary outcomes (5)

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.
Measured: 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.
Measured: Up to two years
Water insecurity measures
Water insecurity, as measured through changes in water insecurity scale scores
Measured: Up to two years
Sanitation insecurity measures
Sanitation insecurity, as measured through changes in sanitation insecurity scale scores
Measured: Up to two years
Collective efficacy measures
Collective efficacy, as measured through changes in collective efficacy scale scores
Measured: Up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Mar 201716 May 2019

First posted9 Mar 2017
Study start7 Mar 2017
Primary completion16 May 2019
Study completion16 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sustained Behavior ChangeStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10,375 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03075436
Sponsor's protocol ID: IRB00076141
Status last verified: Jul 2019
First submitted: 7 Mar 2017
Last updated: 5 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 36962125
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.
PubMed 31226957

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Enhanced, Demand-side Sanitation and Hygiene Promotion on Sustained Behavior Change and Health in Ethiopia
ClinicalTrials.gov ID: NCT03075436
Acronym / sponsor ID: IRB00076141
Conditions: Sustained Behavior Change, Mental Well-being
Keywords: Sanitation, Hygiene, Public Health, Behavior change, Neglected tropical diseases, Demand-side sanitation and hygiene, Mental well-being, Water insecurity
Study type: Interventional
Recruitment status: Completed
Enrolment: 10,375 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Emory Ethiopia, Amhara Regional Health Bureau, Ministry of Health, Ethiopia
Study start: 7 Mar 2017 (actual)
Primary completion: 16 May 2019 (actual)
Study completion: 16 May 2019 (actual)
First posted: 9 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Enhanced demand-side sanitation, hygiene	Experimental	Behavioral: Enhanced demand-side sanitation, hygieneThe 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.
Standard of care	Active comparator	Behavioral: Standard of careThe comparison group will receive the current standard of care, including potential implementation of government-led policies and programs.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enhanced demand-side sanitation, hygieneThe 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.	Behavioural	Enhanced demand-side sanitation, hygiene
Standard of careThe comparison group will receive the current standard of care, including potential implementation of government-led policies and programs.	Behavioural	Standard of care

Primary outcome

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.
Mental well-being measures
Time frame: Up to two years
Mental well-being, as measured through the changes in mental well-being scale scores

5 secondary outcomes

Shorter-term behavioral outcome measures
Time frame: Up to two years
Intermediate behaviour change antecedent measures
Time frame: Up to two years
Water insecurity measures
Time frame: Up to two years
Sanitation insecurity measures
Time frame: Up to two years
Collective efficacy measures
Time frame: Up to two years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Derived from this study: PubMed 36962125Freeman 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.
Derived from this study: PubMed 31226957Delea 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew Freeman, PhD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced demand-side sanitation, hygiene in people with Sustained Behavior Change and Mental Well-being, run by Emory University at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustainability of WASH-related behaviours, including NTD-preventive WASH behavior measures (time frame: Endline (Up to two years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03075436, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.