Clinical trial NCT03075436: The Impact of Enhanced, Demand-side Sanitation and Hygiene Promotion on Sustained Behavior Change and Health in Ethiopia
Official title: The Impact of Enhanced, Demand-side Sanitation and Hygiene Promotion on Sustained Behavior Change and Health in Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Sanitation insecurity
Collective efficacy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Emory Ethiopia
name: Amhara Regional Health Bureau
name: Federal Democratic Republic of Ethiopia Ministry of Health
First posted: 2017-03-09
Enrollment: 10375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sustainability of WASH-related behaviours, including NTD-preventive WASH behavior measures
timeFrame: Endline (Up to two years)
measure: Mental well-being measures
timeFrame: Up to two years
Secondary outcomes:
measure: Shorter-term behavioral outcome measures
timeFrame: Up to two years
measure: Intermediate behaviour change antecedent measures
timeFrame: Up to two years
measure: Water insecurity measures
timeFrame: Up to two years
measure: Sanitation insecurity measures
timeFrame: Up to two years
measure: Collective efficacy measures
timeFrame: Up to two years
Other outcomes:
Locations:
city: Amhara National Regional State
country: Ethiopia
facility: Amhara
Study officials:
affiliation: Emory University
name: Matthew Freeman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.