Infectious DiseaseNCT01043809
Evaluation of a Handwashing Promotion Program in Three Countries
A study testing Procter & Gamble school-based handwashing promotion program and expanded school-based handwashing promotion in people with Infectious Disease and Respiratory Illness, run by Centers for Disease Control and Prevention at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease, Respiratory Illness, Absenteeism
- What is being tested?
- Procter & Gamble school-based handwashing promotion program and expanded school-based handwashing promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2008to Jun 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 19 students per first grade class
- Piped water tap available to every 30 first grade students for handwashing
Who cannot join
- Compulsory handwashing or distribution of hand wipes before school lunch
- Commercial handwashing promotion at school during previous 5 years
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Evaluation of a School-based Handwashing Promotion Program in Three Countries
The purpose of this study is to assess whether simple, school-based handwashing promotion impacts health and hygiene knowledge among students and their families.
- Conditions
- Infectious Disease, Respiratory Illness, Absenteeism
- Being tested
- Procter & Gamble school-based handwashing promotion program, expanded school-based handwashing promotion
- Keywords
- schools, handwashing, prevention and control, communicable diseases, absenteeism
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procter & Gamble school-based handwashing promotion programBehavioural
Handwashing promotion lesson and materials targeting first grade students
expanded school-based handwashing promotionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Randomly selected schools will not receive handwashing intervention |
| 2 | Experimental | Randomly selected schools will get standard commercial school-based handwashing promotion Receives: Behavioral: Procter & Gamble school-based handwashing promotion program |
| 3 | Experimental | Randomly selected schools will receive standard commercial school-based handwashing promotion program, plus an added level of handwashing promotion (varies by country) Receives: Behavioral: expanded school-based handwashing promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
student school absences / 100 student-weeks of observation
Measured: one semester
Secondary outcomes (3)
Student absences due to respiratory illness / 100 student-weeks of observation
Measured: one semester
student absences due to infectious syndromes / 100 student-weeks of observation
Measured: one semester
longitudinal prevalence of infectious syndromes among students' family members
Measured: one semester
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- 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
- Anna Bowen, MD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043809
- Sponsor's protocol ID
- CDC-NCEZID-5281
- Status last verified
- Feb 2013
- First submitted
- 6 Jan 2010
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a School-based Handwashing Promotion Program in Three Countries
- ClinicalTrials.gov ID
- NCT01043809
- Acronym / sponsor ID
- CDC-NCEZID-5281
- Conditions
- Infectious Disease, Respiratory Illness, Absenteeism
- Keywords
- schools, handwashing, prevention and control, communicable diseases, absenteeism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- 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.
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Jan 2010 (estimated)
- 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.
The purpose of this study is to assess whether simple, school-based handwashing promotion impacts health and hygiene knowledge among students and their families.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Randomly selected schools will not receive handwashing intervention |
| 2 | Experimental | Behavioral: Procter & Gamble school-based handwashing promotion programRandomly selected schools will get standard commercial school-based handwashing promotion |
| 3 | Experimental | Behavioral: expanded school-based handwashing promotionRandomly selected schools will receive standard commercial school-based handwashing promotion program, plus an added level of handwashing promotion (varies by country) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 19 students per first grade class
Key exclusion criteria (2 listed)
- Compulsory handwashing or distribution of hand wipes before school lunch
- Commercial handwashing promotion at school during previous 5 years
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 |
|---|---|---|
| Procter & Gamble school-based handwashing promotion programHandwashing promotion lesson and materials targeting first grade students | Behavioural | 2 |
| expanded school-based handwashing promotionProcter \& 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. | Behavioural | 3 |
Primary outcome
student school absences / 100 student-weeks of observation
Time frame: one semester
3 secondary outcomes
Student absences due to respiratory illness / 100 student-weeks of observation
Time frame: one semester
student absences due to infectious syndromes / 100 student-weeks of observation
Time frame: one semester
longitudinal prevalence of infectious syndromes among students' family members
Time frame: one semester
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 6 Feb 2013.
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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.
Anna Bowen, MD, MPH principal investigator
Centers for Disease Control and Prevention
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procter & Gamble school-based handwashing promotion program and expanded school-based handwashing promotion in people with Infectious Disease and Respiratory Illness, run by Centers for Disease Control and Prevention at 3 sites in 3 countries.
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 2 inclusion and 2 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 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Pakistan, Philippines. 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?
student school absences / 100 student-weeks of observation (time frame: one semester). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2013.