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 Arabiaandpresents this protocol to illustrate its feasibility and to promote both collaboration with other research groups and additional relevant studies. Methods/design A cluster-r and omised controlled trial is being conducted to test the efficacy of st and ard 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 'st and ard measures' among pilgrims over several Hajj seasons. Cluster-r and omisation 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 st and ard facemask use in preventing viral respiratory tract infections at mass gatherings. This study is registered at the Australian New Zeal and Clinical Trials Registry [ANZCTR], ACTRN: ACTRN12613001018707 [http://www.anzctr.org.au]
ABSTRACT
The potential for spread of infectious diseases associated with mass gatherings is well recognised. Hajj, the unique annual mass gathering of over 2 million Muslims from all over the world, presents enormous challenges to the authorities in Saudi Arabia. They have a comprehensive programme updated annually, to ensure that all aspects of Hajj rituals are conducted safely and without major incident. The inevitable overcrowding in a confined area of such large numbers increases the risk of respiratory infections. Of these Hajj cough' is the most frequently reported complaint and is caused by a variety of viruses and bacteria. The outbreaks of meningococcal W135 strains in 2000 and 2001 with the associated high mortality showed the potential for international spread at mass gatherings. Collaboration between health policy makers and community leaders in the UK resulted in a rapid and impressive reduction of these infections. On-going disease surveillance and data analysis is necessary to better understand health risks and strengthen evidence base for health policy and prevention. The battle against spread of travel-related infections is a shared responsibility. Countries sending pilgrims should co-ordinate preventive measures by healthcare professionals and community groups. A multi-pronged approach involving awareness programme for pilgrims and their health advisers, supported by rapid diagnosis, timely treatment, prevention by vaccine, community measures, infection prevention and control practices are necessary. The benefits from such measures go beyond the Hajj to protect health and reduce inequalities. Establishing an international centre for public health relating to the Hajj will enable co-ordinating international health action and appropriate intervention