Evaluation of a Handwashing Promotion Program in Three Countries

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01043809
• Collaborator: Procter and Gamble (Industry), Zhejiang Provincial Center for Disease Control and Prevention (Other), Centers for Disease Control and Prevention, China (Other), Project HOPE (Other), Field Epidemiology Training Program Alumni Foundation, Inc. (Other)
• Enrollment: 15,000
• Locations: 3
• Arms: 3
• Duration (Months): 5
• Patients Per Site: 5000
• Patients Per Site Per Month: 1001.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess whether simple, school-based handwashing promotion impacts health and hygiene knowledge among students and their families.

Condition or Disease	Intervention/Treatment	Phase
Infectious Disease; Respiratory Illness; Absenteeism	Behavioral: Procter & Gamble school-based handwashing promotion program; Behavioral: expanded school-based handwashing promotion	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of a School-based Handwashing Promotion Program in Three Countries
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 Randomly selected schools will not receive handwashing intervention
Experimental: 2 Randomly selected schools will get standard commercial school-based handwashing promotion	Behavioral: Procter & Gamble school-based handwashing promotion program; Handwashing promotion lesson and materials targeting first grade students
Experimental: 3 Randomly selected schools will receive standard commercial school-based handwashing promotion program, plus an added level of handwashing promotion (varies by country)	Behavioral: expanded school-based handwashing promotion; Procter & Gamble's standard school-based handwashing promotion education and materials targeting first grade students, plus a program enhancement. In China, enhancement consists of a supply of soap for school sinks. In Pakistan, enhancement consists of soap for school sinks, plus enlistment of a peer hygiene champion in each first grade class. In the Philippines, enhancement consists of enlistment of a peer hygiene champion in each first grade class.

Outcome Measures

Primary Outcome Measures

1. student school absences / 100 student-weeks of observation [one semester]

Secondary Outcome Measures

1. Student absences due to respiratory illness / 100 student-weeks of observation [one semester]

2. student absences due to infectious syndromes / 100 student-weeks of observation [one semester]

3. longitudinal prevalence of infectious syndromes among students' family members [one semester]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 19 students per first grade class

• Piped water tap available to every 30 first grade students for handwashing

Exclusion Criteria:

• Compulsory handwashing or distribution of hand wipes before school lunch

• Commercial handwashing promotion at school during previous 5 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Province CDC	Hangzhou	Zhejiang	China
2	Project HOPE	Karachi	Sindh	Pakistan
3	FETPAFI	Manila		Philippines

Sponsors and Collaborators

• Centers for Disease Control and Prevention
• Procter and Gamble
• Zhejiang Provincial Center for Disease Control and Prevention
• Centers for Disease Control and Prevention, China
• Project HOPE
• Field Epidemiology Training Program Alumni Foundation, Inc.

Investigators

• Principal Investigator: Anna Bowen, MD, MPH, Centers for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01043809
• Other Study ID Numbers: CDC-NCEZID-5281
• First Posted: Jan 7, 2010
• Last Update Posted: Feb 6, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by , ,: schools; handwashing; prevention and control; communicable diseases; absenteeism
• Additional relevant MeSH terms: Communicable Diseases; Infections

Study Results

No Results Posted as of Feb 6, 2013