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A cluster-randomised controlled trial to test the efficacy of facemasks in preventing respiratory viral infection among Hajj pilgrims

Wang, Mandy; Barasheed, Osamah; Rashid, Harunor; Booy, Robert; El Bashir, Haitham; Haworth, Elizabeth; Ridda, Iman; Holmes, Edward C.; Dwyer, Dominic E.; Nguyen-Van-Tam, Jonathan; Memish, Ziad A.; Heron, Leon

Authors

Mandy Wang

Osamah Barasheed

Harunor Rashid

Robert Booy

Haitham El Bashir

Elizabeth Haworth

Iman Ridda

Edward C. Holmes

Dominic E. Dwyer

Jonathan Nguyen-Van-Tam

Ziad A. Memish

Leon Heron



Abstract

BACKGROUND: Cost-effective interventions are needed to control the transmission of viral respiratory tract infections (RTIs) in mass gatherings. Facemasks are a promising preventive measure, however, previous studies on the efficacy of facemasks have been inconclusive. This study proposes a large-scale facemask trial during the Hajj pilgrimage in Saudi Arabia and presents this protocol to illustrate its feasibility and to promote both collaboration with other research groups and additional relevant studies.

METHODS/DESIGN: A cluster-randomised controlled trial is being conducted to test the efficacy of standard facemasks in preventing symptomatic and proven viral RTIs among pilgrims during the Hajj season in Mina, Mecca, Saudi Arabia. The trial will compare the 'supervised use of facemasks' versus 'standard measures' among pilgrims over several Hajj seasons. Cluster-randomisation will be done by accommodation tents with a 1:1 ratio. For the intervention tents, free facemasks will be provided to be worn consistently for 7days. Data on flu-like symptoms and mask use will be recorded in diaries. Nasal samples will be collected from symptomatic recruits and tested for nucleic acid of respiratory viruses. Data obtained from questionnaires, diaries and laboratory tests will be analysed to examine whether mask use significantly reduces the frequency of laboratory-confirmed respiratory viral infection and syndromic RTI as primary outcomes.

CONCLUSIONS: This trial will provide valuable evidence on the efficacy of standard facemask use in preventing viral respiratory tract infections at mass gatherings. This study is registered at the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12613001018707 (http://www.anzctr.org.au).

Journal Article Type Article
Journal Journal of Epidemiology and Global Health
Print ISSN 2210-6006
Electronic ISSN 2210-6014
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 5
Issue 2
APA6 Citation Wang, M., Barasheed, O., Rashid, H., Booy, R., El Bashir, H., Haworth, E., …Heron, L. (in press). A cluster-randomised controlled trial to test the efficacy of facemasks in preventing respiratory viral infection among Hajj pilgrims. Journal of Epidemiology and Global Health, 5(2), doi:10.1016/j.jegh.2014.08.002
DOI https://doi.org/10.1016/j.jegh.2014.08.002
Keywords Facemask, Hajj pilgrimage, Influenza, Middle East respiratory syndrome coronavirus, Viral respiratory tract infection
Publisher URL http://ac.els-cdn.com/S2210600614000781/1-s2.0-S2210600614000781-main.pdf?_tid=558800be-a3f1-11e5-9ff7-00000aacb35f&acdnat=1450269442_7a6fbb28143665b612f903f1a5b58a1d
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc-nd/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc-nd/4.0





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