Intervention Study of Face Mask and Hand Sanitizer to Reduce Influenza Transmission
M-FLU
Reducing the Transmission of Influenza by Face Masks
1 other identifier
interventional
1,420
1 country
1
Brief Summary
Pharmaceutical interventions, particularly vaccination, have been the principal public health method of preventing and controlling seasonal influenza. Other less invasive non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia, masks are used extensively, especially in Japan, but with only circumstantial evidence of efficacy. Although there are numerous studies that support hand hygiene as an effective measure for decreasing transmission of enteric infections, there are fewer data assessing the effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be conducted on the use of face masks with and without the use of hand hygiene in comparison to no intervention in residence housing units of the University of Michigan. The interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. When illness occurs meeting a case definition, specimens for viral isolation will be collected in all intervention settings. Face masks could theoretically lead to a large reduction in transmission frequency of influenza, especially if most transmission occurs by the airborne (large or small droplet) route. Even a modest reduction could have a major effect during an influenza pandemic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2006
1 active site
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
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 21, 2007
CompletedFirst Posted
Study publicly available on registry
June 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedAugust 19, 2011
June 1, 2007
1.5 years
June 21, 2007
August 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of laboratory confirmed cases of Influenza
8 weeks, including the 6 weeks of intervention and two weeks post-intervention
Secondary Outcomes (1)
Number of cases of Influenza Like Illness
6 weeks of intervention
Study Arms (3)
Facemask and hand hygiene
EXPERIMENTALFacemask and hand hygiene provided for participants.
Facemask only
EXPERIMENTALFacemask only provided for participants.
Control
NO INTERVENTIONControl, no intervention.
Interventions
Facemasks were requested to be worn while participants were in the residence hall for year one, and while they were in residence halls for a minimum of six hours per day in year two.
Hand sanitizer was provided to participants in the facemask and hand hygiene arm for year one and year two of the study.
Eligibility Criteria
You may qualify if:
- Residence in selected University of Michigan Residence Halls
You may not qualify if:
- Non-residence in selected Residence Halls
- Unwillingness to utilize face mask and hand sanitizer and complete online surveys
- Already study employee
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Centers for Disease Control and Preventioncollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48104, United States
Related Publications (5)
Aiello AE, Murray GF, Perez V, Coulborn RM, Davis BM, Uddin M, Shay DK, Waterman SH, Monto AS. Mask use, hand hygiene, and seasonal influenza-like illness among young adults: a randomized intervention trial. J Infect Dis. 2010 Feb 15;201(4):491-8. doi: 10.1086/650396.
PMID: 20088690RESULTJefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.
PMID: 36715243DERIVEDJefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
PMID: 33215698DERIVEDAiello AE, Perez V, Coulborn RM, Davis BM, Uddin M, Monto AS. Facemasks, hand hygiene, and influenza among young adults: a randomized intervention trial. PLoS One. 2012;7(1):e29744. doi: 10.1371/journal.pone.0029744. Epub 2012 Jan 25.
PMID: 22295066DERIVEDPerez V, Uddin M, Galea S, Monto AS, Aiello AE. Stress, adherence to preventive measures for reducing influenza transmission and influenza-like illness. J Epidemiol Community Health. 2012 Jul;66(7):605-10. doi: 10.1136/jech.2010.117002. Epub 2011 Jan 10.
PMID: 21224242DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnold S Monto, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Allison E Aiello, PhD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 21, 2007
First Posted
June 25, 2007
Study Start
October 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
August 19, 2011
Record last verified: 2007-06