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

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

doi:10.1016/j.jegh.2014.08.002

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Volume 5, Issue 2, June 2015, Pages 181 - 189

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

Authors

Mandy Wang^a, Osamah Barasheed^a^{, *}^,osamah.barasheed@health.nsw.gov.au, Harunor Rashid^a, Robert Booy^a^{, b}, Haitham El Bashir^c, Elizabeth Haworth^d, Iman Ridda^a, Edward C. Holmes^b, Dominic E. Dwyer^b^{, e}, Jonathan Nguyen-Van-Tam^f, Ziad A. Memish^g, Leon Heron^a

^aNational Centre for Immunisation Research and Surveillance (NCIRS), The Children’s Hospital at Westmead, NSW, Australia

^bMarie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Australia

^cHamad Medical Corporation, Doha, Qatar

^dMenzies Research Institute Tasmania, Hobart, Tasmania, Australia

^eCentre for Infectious Diseases and Microbiology Laboratory Services (CIDMLS), Westmead Hospital, NSW, Australia

^fDivision of Epidemiology and Public Health, University of Nottingham (World Health Organization Collaborating Centre for Pandemic Influenza and Research), UK

^gMinistry of Health and College of Medicine, Alfaisal University, Riyadh, Saudi Arabia

^*Corresponding author at: National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Locked Bag 4001, Westmead, NSW 2145, Australia. Tel.: +61 423 572 670; fax: +61 2 9845 1418.

Corresponding Author

Osamah Barasheedosamah.barasheed@health.nsw.gov.au

Received 14 May 2014, Revised 30 July 2014, Accepted 2 August 2014, Available Online 2 October 2014.

DOI: 10.1016/j.jegh.2014.08.002 How to use a DOI?
Keywords: Facemask; Hajj pilgrimage; Influenza; Middle East respiratory syndrome coronavirus; Viral respiratory tract infection
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 7 days. 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).
Open Access: This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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Journal: Journal of Epidemiology and Global Health
Volume-Issue: 5 - 2
Pages: 181 - 189
Publication Date: 2014/10/02
ISSN (Online): 2210-6014
ISSN (Print): 2210-6006
DOI: 10.1016/j.jegh.2014.08.002 How to use a DOI?
Open Access: This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Cite this article

ris enw bib

TY  - JOUR
AU  - Mandy Wang
AU  - Osamah Barasheed
AU  - Harunor Rashid
AU  - Robert Booy
AU  - Haitham El Bashir
AU  - Elizabeth Haworth
AU  - Iman Ridda
AU  - Edward C. Holmes
AU  - Dominic E. Dwyer
AU  - Jonathan Nguyen-Van-Tam
AU  - Ziad A. Memish
AU  - Leon Heron
PY  - 2014
DA  - 2014/10/02
TI  - A cluster-randomised controlled trial to test the efficacy of facemasks in preventing respiratory viral infection among Hajj pilgrims
JO  - Journal of Epidemiology and Global Health
SP  - 181
EP  - 189
VL  - 5
IS  - 2
SN  - 2210-6014
UR  - https://doi.org/10.1016/j.jegh.2014.08.002
DO  - 10.1016/j.jegh.2014.08.002
ID  - Wang2014
ER  -

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