Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Jun;5(2):181-9.
doi: 10.1016/j.jegh.2014.08.002. Epub 2014 Oct 2.

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

Mandy Wang  1 , Osamah Barasheed  2 , Harunor Rashid  1 , Robert Booy  3 , Haitham El Bashir  4 , Elizabeth Haworth  5 , Iman Ridda  1 , Edward C Holmes  6 , Dominic E Dwyer  7 , Jonathan Nguyen-Van-Tam  8 , Ziad A Memish  9 , Leon Heron  1
Affiliations
Randomized Controlled Trial

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

Mandy Wang et al. J Epidemiol Glob Health. 2015 Jun.

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).

Keywords: Facemask; Hajj pilgrimage; Influenza; Middle East respiratory syndrome coronavirus; Viral respiratory tract infection.

PubMed Disclaimer

Conflict of interest statement

Professor Robert Booy and Dr. Leon Heron have received funding from Baxter, CSL, GSK, Merck, Novartis, Pfizer, Roche, Romark and Sanofi Pasteur for the conduct of sponsored research, travel to present at conferences or consultancy work; all funding received are directed to research accounts at The Children’s Hospital at Westmead. Dr. Iman Ridda has received Grants for investigator-driven research from GSK and for consultation from Merck. The other authors have declared no conflict of interest in relation to this work.

Figures

Fig. 1
Fig. 1
Comparison between mask and control groups in randomised trials (adapted from Rashid et al. with the inclusion of an additional study [9,18]).
Fig. 2
Fig. 2
Key steps of the study at the Hajj 2014 (these key steps will remain the same in 2015 except that the recruitment dates will advance by 11 days).
See this image and copyright information in PMC

References

    1. World Health Organization Global influenza programme: pandemic influenza preparedness and response, WHO guidance document 2009. Available from: http://www.who.int/influenza/resources/documents/pandemic_guidance_04_20... (accessed 4 July, 2014). - PubMed
    1. de Groot RJ, Baker SC, Baric RS, Brown CS, Drosten C, Enjuanes L, et al. Middle East Respiratory Syndrome Coronavirus (MERS-CoV); announcement of the Coronavirus Study Group. J Virol. 2013;87:7790–2. doi: 10.1128/jvi.01244-13. - DOI - PMC - PubMed
    1. Memish ZA, Zumla A, Alhakeem RF, Assiri A, Turkestani A, Al Harby KD, et al. Hajj: infectious disease surveillance and control. Lancet. 2014;383:2073–82. doi: 10.1016/s0140-6736(14)60381-0. - DOI - PMC - PubMed
    1. Blyth CC, Foo H, van Hal SJ, Hurt AC, Barr IG, McPhie K, et al. Influenza outbreaks during the World Youth Day 2008 mass gathering. Emerg Infect Dis. 2010;16:809–15. doi: 10.3201/eid1605.091136. - DOI - PMC - PubMed
    1. Haworth E, Barasheed O, Memish ZA, Rashid H, Booy R. Prevention of influenza at Hajj: applications for mass gatherings. J R Soc Med. 2013;106:215–23. doi: 10.1258/jrsm.2012.120170. - DOI - PMC - PubMed

Publication types