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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04929860
Other study ID # WT-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2011
Est. completion date April 2012

Study information

Verified date June 2011
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1747
Est. completion date April 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - households with children of primary school age or younger Exclusion Criteria: - households without school-aged or younger children

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
social marketing campaign
social marketing campaign delivered over 4 weeks in 4 separate sessions

Locations

Country Name City State
India St. John's Research Institute Palamener Andra Pradesh

Sponsors (2)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine St. John's Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Handwashing with soap directly observed cross sectional survey using direct observation of householders by local study staff one months after interventions is terminated
Secondary Soap use measured by motion detectors embedded in soap bars soap movements over one week one month after assessment of the primary outcome
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