A cluster-randomised controlled trial to test the efficacy of facemasks in preventing respiratory viral infection among Hajj pilgrims.
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
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).
National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.
Mandy
M
Wang
National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia. Electronic address: osamah.barasheed@health.nsw.gov.au.
Osamah
O
Barasheed
National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.
Harunor
H
Rashid
National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Australia.
Robert
R
Booy
Hamad Medical Corporation, Doha, Qatar.
Haitham
H
El Bashir
Menzies Research Institute Tasmania, Hobart, Tasmania, Australia.
Elizabeth
E
Haworth
National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.
Iman
I
Ridda
Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Australia.
Edward C
EC
Holmes
Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Australia; Centre for Infectious Diseases and Microbiology Laboratory Services (CIDMLS), Westmead Hospital, NSW, Australia.
Dominic E
DE
Dwyer
Division of Epidemiology and Public Health, University of Nottingham (World Health Organization Collaborating Centre for Pandemic Influenza and Research), UK.
Jonathan
J
Nguyen-Van-Tam
Ministry of Health and College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Ziad A
ZA
Memish
National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.
Leon
L
Heron
D005260:Female; D006801:Humans; D007251:Influenza, Human / Q000517:prevention & control*; D007514:Islam; D008297:Male; D008397:Masks; D012529:Saudi Arabia; D014195:Travel
Facemask; Hajj pilgrimage; Influenza; Middle East respiratory syndrome coronavirus; Viral respiratory tract infection