NCT04929860

Brief Summary

The research will test the hypothesis that a scalable behaviour change intervention can improve hand-washing practices in rural Indian households. The intervention will be designed using a social marketing approach and will use motivational messages targeting key audiences rather than educational messages about germs and disease which previously have been found ineffective. The intervention will be designed for low-cost, scaleable delivery using a series of visits to target villages by a two-person team on a motorbike. The key goal of the study is to determine the effectiveness of a scaleable, social marketing intervention to promote hand-washing with soap. The study will take the form of a cluster-randomized, controlled intervention trial. Villages will be randomized to receive either the intervention or no intervention. The primary outcome measure will be the proportion of key events (defecation, faecal contact or food handling) accompanied by hand-washing with soap. These data will be collected by direct observation. A secondary outcome measure will be the number of soap movement episodes. These data will be collected in a sub-sample of households by using electronic motion detectors embedded in bars of soap. Additionally, questionnaires will be used to collect data on social norms, self-reported soap use and habitual soap use. All data will be collected pre and post-intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,747

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

June 10, 2021

Last Update Submit

June 16, 2021

Conditions

Keywords

diarrhoeahandwashinghygiene

Outcome Measures

Primary Outcomes (1)

  • Handwashing with soap directly observed

    cross sectional survey using direct observation of householders by local study staff

    one months after interventions is terminated

Secondary Outcomes (1)

  • Soap use measured by motion detectors embedded in soap bars

    soap movements over one week one month after assessment of the primary outcome

Study Arms (2)

handwashing

ACTIVE COMPARATOR

This arm receives a scalable social marketing campaign using innovative behaviour change approaches to improve handwashing. The intervention is delivered by a commercial social marketing business unrelated to the investigating organisations

Behavioral: social marketing campaign

control

NO INTERVENTION

Interventions

social marketing campaign delivered over 4 weeks in 4 separate sessions

handwashing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • households with children of primary school age or younger

You may not qualify if:

  • households without school-aged or younger children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. John's Research Institute

Palamener, Andhra Pradesh, India

Location

MeSH Terms

Conditions

BehaviorDiarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 18, 2021

Study Start

July 1, 2011

Primary Completion

February 1, 2012

Study Completion

April 1, 2012

Last Updated

June 18, 2021

Record last verified: 2011-06

Locations