The relationship between hand hygiene and rates of acute respiratory infections among Umrah pilgrims: A pilot randomised controlled trial

Background: There is a lack of randomised controlled trials (RCTs) investigating the role of hand hygiene in preventing and containing acute respiratory infections (ARIs) in mass gatherings. In this pilot RCT, we assessed the feasibility of establishing a large-scale trial to explore the relationshi...

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Main Authors: Aqel Albutti, Hashim A. Mahdi, Ameen S. Alwashmi, Mohammad Alfelali, Osamah Barasheed, Elizabeth H. Barnes, Ramon Z. Shaban, Robert Booy, Harunor Rashid
Format: Article
Language:English
Published: Elsevier 2024-04-01
Series:Journal of Infection and Public Health
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1876034123001223
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author Aqel Albutti
Hashim A. Mahdi
Ameen S. Alwashmi
Mohammad Alfelali
Osamah Barasheed
Elizabeth H. Barnes
Ramon Z. Shaban
Robert Booy
Harunor Rashid
author_facet Aqel Albutti
Hashim A. Mahdi
Ameen S. Alwashmi
Mohammad Alfelali
Osamah Barasheed
Elizabeth H. Barnes
Ramon Z. Shaban
Robert Booy
Harunor Rashid
author_sort Aqel Albutti
collection DOAJ
description Background: There is a lack of randomised controlled trials (RCTs) investigating the role of hand hygiene in preventing and containing acute respiratory infections (ARIs) in mass gatherings. In this pilot RCT, we assessed the feasibility of establishing a large-scale trial to explore the relationship between practising hand hygiene and rates of ARI in Umrah pilgrimage amidst the COVID-19 pandemic. Methods: A parallel RCT was conducted in hotels in Makkah, Saudi Arabia, between April and July 2021. Domestic adult pilgrims who consented to participate were randomised 1:1 to the intervention group who received alcohol-based hand rub (ABHR) and instructions, or to the control group who did not receive ABHR or instructions but were free to use their own supplies. Pilgrims in both groups were then followed up for seven days for ARI symptoms. The primary outcome was the difference in the proportions of syndromic ARIs among pilgrims between the randomised groups. Results: A total of 507 (control: intervention = 267: 240) participants aged between 18 and 75 (median 34) years were randomised; 61 participants were lost to follow-up or withdrew leaving 446 participants (control: intervention = 237:209) for the primary outcome analysis; of whom 10 (2.2 %) had developed at least one respiratory symptom, three (0.7 %) had ‘possible ILI’ and two (0.4 %) had ‘possible COVID-19′. The analysis of the primary outcome found no evidence of difference in the proportions of ARIs between the randomised groups (odds ratio 1.1 [0.3–4.0] for intervention relative to control). Conclusion: This pilot trial suggests that conducting a future definitive RCT to assess the role of hand hygiene in the prevention of ARIs is feasible in Umrah setting amidst such a pandemic; however, outcomes from this trial are inconclusive, and such a study would need to be very large given the low rates of outcomes observed here. Trial registration: This trial was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12622001287729), the full protocol can be accessed there.
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spelling doaj.art-23e43b9d753148bd8cac4e18be7a67442024-03-21T05:36:06ZengElsevierJournal of Infection and Public Health1876-03412024-04-01173441The relationship between hand hygiene and rates of acute respiratory infections among Umrah pilgrims: A pilot randomised controlled trialAqel Albutti0Hashim A. Mahdi1Ameen S. Alwashmi2Mohammad Alfelali3Osamah Barasheed4Elizabeth H. Barnes5Ramon Z. Shaban6Robert Booy7Harunor Rashid8Department of Medical Biotechnology, College of Applied Medical Sciences, Qassim University, Buraydah 51452, Saudi Arabia; Corresponding author.National Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, Westmead, NSW 2145, Australia; Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, NSW 2145, Australia; Department of Public Health, College of Health Sciences, Saudi Electronic University, Jeddah 23442, Saudi ArabiaDepartment of Medical Laboratories, College of Applied Medical Sciences, Qassim University, Buraydah 51452, Saudi ArabiaFamily and Community Medicine Department, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah 25732, Saudi ArabiaThe Executive Administration of Research and Innovation, King Abdullah Medical City in Holy Capital (KAMC-HC), Makkah 24246, Saudi ArabiaNHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2006, AustraliaNew South Wales Biocontainment Centre, New South Wales Ministry of Health, Westmead, NSW 2151, Australia; Faculty of Medicine and Health Susan Wakil School of Nursing, The University of Sydney, Sydney, NSW 2006, Australia; Public Health Unit, Centre for Population Health, Western Sydney Local Health District, North Parramatta, NSW 2151, Australia; Sydney Infectious Diseases Institute, The University of Sydney, Westmead, NSW 2145, AustraliaNational Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, Westmead, NSW 2145, Australia; Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, NSW 2145, Australia; Sydney Infectious Diseases Institute, The University of Sydney, Westmead, NSW 2145, AustraliaNational Centre for Immunisation Research and Surveillance, The Children’s Hospital at Westmead, Westmead, NSW 2145, Australia; Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, NSW 2145, Australia; Sydney Infectious Diseases Institute, The University of Sydney, Westmead, NSW 2145, AustraliaBackground: There is a lack of randomised controlled trials (RCTs) investigating the role of hand hygiene in preventing and containing acute respiratory infections (ARIs) in mass gatherings. In this pilot RCT, we assessed the feasibility of establishing a large-scale trial to explore the relationship between practising hand hygiene and rates of ARI in Umrah pilgrimage amidst the COVID-19 pandemic. Methods: A parallel RCT was conducted in hotels in Makkah, Saudi Arabia, between April and July 2021. Domestic adult pilgrims who consented to participate were randomised 1:1 to the intervention group who received alcohol-based hand rub (ABHR) and instructions, or to the control group who did not receive ABHR or instructions but were free to use their own supplies. Pilgrims in both groups were then followed up for seven days for ARI symptoms. The primary outcome was the difference in the proportions of syndromic ARIs among pilgrims between the randomised groups. Results: A total of 507 (control: intervention = 267: 240) participants aged between 18 and 75 (median 34) years were randomised; 61 participants were lost to follow-up or withdrew leaving 446 participants (control: intervention = 237:209) for the primary outcome analysis; of whom 10 (2.2 %) had developed at least one respiratory symptom, three (0.7 %) had ‘possible ILI’ and two (0.4 %) had ‘possible COVID-19′. The analysis of the primary outcome found no evidence of difference in the proportions of ARIs between the randomised groups (odds ratio 1.1 [0.3–4.0] for intervention relative to control). Conclusion: This pilot trial suggests that conducting a future definitive RCT to assess the role of hand hygiene in the prevention of ARIs is feasible in Umrah setting amidst such a pandemic; however, outcomes from this trial are inconclusive, and such a study would need to be very large given the low rates of outcomes observed here. Trial registration: This trial was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12622001287729), the full protocol can be accessed there.http://www.sciencedirect.com/science/article/pii/S1876034123001223Acute respiratory infectionsCOVID-19Hand hygieneMass gatheringPilgrimsRandomised controlled trial
spellingShingle Aqel Albutti
Hashim A. Mahdi
Ameen S. Alwashmi
Mohammad Alfelali
Osamah Barasheed
Elizabeth H. Barnes
Ramon Z. Shaban
Robert Booy
Harunor Rashid
The relationship between hand hygiene and rates of acute respiratory infections among Umrah pilgrims: A pilot randomised controlled trial
Journal of Infection and Public Health
Acute respiratory infections
COVID-19
Hand hygiene
Mass gathering
Pilgrims
Randomised controlled trial
title The relationship between hand hygiene and rates of acute respiratory infections among Umrah pilgrims: A pilot randomised controlled trial
title_full The relationship between hand hygiene and rates of acute respiratory infections among Umrah pilgrims: A pilot randomised controlled trial
title_fullStr The relationship between hand hygiene and rates of acute respiratory infections among Umrah pilgrims: A pilot randomised controlled trial
title_full_unstemmed The relationship between hand hygiene and rates of acute respiratory infections among Umrah pilgrims: A pilot randomised controlled trial
title_short The relationship between hand hygiene and rates of acute respiratory infections among Umrah pilgrims: A pilot randomised controlled trial
title_sort relationship between hand hygiene and rates of acute respiratory infections among umrah pilgrims a pilot randomised controlled trial
topic Acute respiratory infections
COVID-19
Hand hygiene
Mass gathering
Pilgrims
Randomised controlled trial
url http://www.sciencedirect.com/science/article/pii/S1876034123001223
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