Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001287729
Ethics application status
Approved
Date submitted
25/09/2022
Date registered
4/10/2022
Date last updated
4/10/2022
Date data sharing statement initially provided
4/10/2022
Date results information initially provided
4/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The relationship between hand hygiene and rates of acute respiratory infections (ARI) among Umrah pilgrims: A pilot randomised controlled trial
Scientific title
Effect of hand hygiene on rates of respiratory-tract infection transmission among Umrah and Hajj pilgrims: a feasibility trial
Secondary ID [1] 308029 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory infections 327708 0
COVID-19 327709 0
Influenza-like illness 327710 0
Condition category
Condition code
Infection 324787 324787 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a pilot trial to test the efficacy of hand hygiene (HH) in preventing acute viral respiratory tract infections (RTIs) including influenza and COVID-19. The intervention is 'supervised HH'.
The study setting is the hotels in Makkah where pilgrims reside. A bottle of 100 ml of antibacterial hand rub (ABHR) that is locally available and approved by the Saudi Food and Drug Authority (Pure & Clean Hand Sanitizer Gel [70% Ethanol], Manufacture: Alkhuraiji factory for Perfumes and Cosmetic, KSA) was supplied for free to each participant in the intervention group to use for 7 days. In addition, study members practically demonstrated the correct method on how to use the product to participants and helped them to clean their hands for the first time. The method of delivery was face-face, with direct demonstration of how to clean hands with ABHR over a single half an hour session.
The compliance with the intervention was categorised based on the frequency of using HH per day: 'less frequently' was defined as <5 times/day, or 'more frequently' as 5 times or more/day.
Adherence to HH was followed up for one week (7 days) starting from the next day of enrolment by using the computer-assisted telephone interview (CATI) technique, any development of respiratory symptoms and hand allergy were also collected .
Intervention code [1] 324482 0
Prevention
Comparator / control treatment
The comparator is ‘no use of supervised HH’ (i.e., standard care where researchers would not provide HH products but the participants may use their own). I.e,, the participants in this arm were not provided any HH solution or any active advice to use HH, but they were allowed to use their own supply of HH products if they wished. In this case they were requested to report it.
The participants were followed up for one week (7 days) starting from the next day of enrolment by using the computer-assisted telephone interview (CATI) technique. They were asked if the developed any respiratory symptom and whether they used any HH product (from their own) including the frequency and duration of use.
Control group
Active

Outcomes
Primary outcome [1] 332613 0
The primary outcome was the difference in the point prevalence of RTIs between pilgrims in the randomised groups.

A study-specific questionnaire was administered to capture development of respiratory symptoms other symptoms during the study period. To estimate the relationship between HH and rates of RTIs among Umrah pilgrims, we used broad clinical criteria to define a new case of RTI. It was defined as the development of at least one respiratory symptom, including cough, sore throat, rhinitis, dyspnoea, and smell or taste dysfunction, within the study period (i.e., from the next day following the enrolment until the day of follow-up). Additionally, we estimated the point prevalence of ‘possible ILI’ and ‘possible COVID-19’ cases among our trial participants by applying syndromic definitions. The ILI definition was described by Rashid et al. as ‘a triad of subjective fever, cough, and sore throat’ (Rashid et al. Int J Infect Dis 2008;12:102-3). A syndromic definition of COVID-19 used by Adorni et al. as the ‘concomitant presence of three or more of the following symptoms: fever, myalgia, cough, and smell or taste dysfunction’ was applied (Adorni et al. JMIR Public Health Surveill 2020;6:e21866).
Timepoint [1] 332613 0
1 week after enrolment
Secondary outcome [1] 414055 0
To evaluate the efficacy of HH against laboratory-confirmed viral RTIs by using pharyngeal swabs for viral detection by RCT-PCR.
Timepoint [1] 414055 0
1 week after enrolment
Secondary outcome [2] 414218 0
Compliance of HH use.

During CATI interview, participants were asked to report compliance with HH over 7 days. The compliance with the intervention was categorised based on the frequency of using ABHR per day: ‘less frequently’ was defined as <5 times/day, or ‘more frequently’ as 5 times or more/day. Lastly, information about facilitators of, and barriers to HH practice, and any skin reactions were also collected.
Timepoint [2] 414218 0
Within 7 days of enrolment

Eligibility
Key inclusion criteria
Inclusion criteria:
• Domestic Umrah and Hajj pilgrims (i.e., residents of Saudi Arabia) of all genders aged 18 years or above .
• Have provided signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Children aged <18 years.
• Participation in another clinical trial investigating a medical intervention that may interfere with study outcome measures like proven viral RTI.
• Those who have flu-like symptoms during the time of recruitment.
• Known contraindication to HH product (e.g., allergy to any component of HH product).
• Individuals not having a full mental capacity to comprehend the consent form.
• Those who refuse to sign the consent form

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to study arm could not be concealed as the the subjects knew to which group they were assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
With random numbers that were generated beforehand for each hotel by using an online random number allocation software application ( https://www.sealedenvelope.com/simple-randomiser/v1/lists ).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To ensure the confidentiality of participants, all responses from the baseline questionnaires and daily health forms will be recorded and stored on a highly protected cloud-based survey application (Microsoft Forms). Apart from investigators or their authorised delegates, no one else will have access to the records.
All the collected data in the software will be exported to a master Excel spreadsheet for cleaning and coding before importing to Statistical Package for Social Sciences (SPSS) software (IBM SPSS Statistics for Windows, version 26.0, IBM Corp, Armonk, NY, USA).
Frequencies and percentages will be used to present the categorical variables, while the mean (or median with range) ± standard deviation (SD) will be used to summarise continuous variables. A p-value = 0.05 will be considered to be statistically significant. Exploratory multivariable analyses will examine the effect of randomised treatment on outcomes in models adjusted for demographic factors, HH use and compliance with treatment. Subgroup analyses will be attempted to compare the effect of treatment between groups of participants: male vs. female, those with known risk factors vs. those without risk factors or risk status unknown for viral respiratory infections, vaccinated against influenza and COVID-19 vs. unvaccinated (or vaccination status reported as unknown), smoker vs. non-smoker, and by pilgrim’s country of origin.
Data available from questionnaires, diaries and laboratory tests will be analysed anonymously to examine whether HH use makes a significant difference in reducing the frequency of laboratory-confirmed respiratory virus infection (including influenza, coronavirus or other respiratory viruses). The primary endpoints (effectiveness and efficacy of HH against clinical and laboratory-confirmed viruses respectively) will be analysed by intention to treat.
The self-reported uptake rates of vaccination against influenza and COVID-19 will be determined and vaccine effectiveness will be estimated based on the case-negative case-control methodology. The results from the genomic sequencing of influenza and SARS-CoV-2 viruses will assist us in understanding the genetic relatedness of circulating virus strains at Hajj and the transmission pattern of these viruses among pilgrims.
Sample size calculation
Assuming that the prevalence of symptomatic RTIs is 30% in the controls and the prevalence of laboratory-proven viral RTIs in controls is approximately 12% the HH arm could be considered clinically worthwhile if it can reduce the prevalence of syndromic or proven viral RTI by 50% (Al-Tawfiq JA et al. Curr Opin Pulm Med 2013; 19:192-7; Memish ZA, et al. J Travel Med 2012;19:15-21).
Assuming a moderate intra-cluster correlation of 10% and a mean of 75 participants per cluster, and inflating the sample by a factor of 8.4 to account for clustering, the sample size required for an ideal cluster RCT to detect a reduction from 12% to 6% with 80% power at 5% significance is 3000 per arm. However, this being a pilot trial, from our previous experience, one-tenth of it i.e., about 300 participants in each arm (totaling 600) would provide just sufficient sample for pilot analysis. It is expected that about 15% of these will be symptomatic thus roughly about 100 samples will be available for virological analysis.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Logistic issues arose during COVID-19 pandemic
Date of first participant enrolment
Anticipated
Actual
22/04/2021
Date of last participant enrolment
Anticipated
Actual
1/07/2021
Date of last data collection
Anticipated
Actual
15/07/2021
Sample size
Target
600
Accrual to date
Final
446
Recruitment outside Australia
Country [1] 25018 0
Saudi Arabia
State/province [1] 25018 0

Funding & Sponsors
Funding source category [1] 312291 0
University
Name [1] 312291 0
Qassim University, Saudi Arabia
Country [1] 312291 0
Saudi Arabia
Primary sponsor type
Other Collaborative groups
Name
Sydney Infectious Diseases Institute
Address
Sydney Infectious Diseases Institute, Westmead Hospital, Level 5, Block K , Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 313836 0
University
Name [1] 313836 0
Qassim University
Address [1] 313836 0
Qassim University, Deanship of Scientific Research, P.O.Box 6688, Buraydah, Post Code 51452, Al Qaseem, Saudi Arabia
Country [1] 313836 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311660 0
King Abdulla Medical City in Holy capital
Ethics committee address [1] 311660 0
Al Mashair, Mecca 24246. Mecca. 21955, Saudi Arabia
Ethics committee country [1] 311660 0
Saudi Arabia
Date submitted for ethics approval [1] 311660 0
Approval date [1] 311660 0
11/04/2021
Ethics approval number [1] 311660 0
IRB Reg no. H-02-K-001

Summary
Brief summary
The aim of this pilot RCT trial was to test the relationship between practising HH and rates of ARI among Hajj and Umrah pilgrims in order to assess feasibility of establishing a large-scale HH trial in preventing RTIs. A parallel pilot RCT was conducted in hotels in Makkah, the Kingdom of Saudi Arabia, between April and July 2021. Domestic adult pilgrims who were free from respiratory symptoms at the time of recruitment and agreed to participate were eligible. Consented pilgrims 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 but were free to use their supplies. Pilgrims in both groups were then followed up after seven days to report the development of symptoms. The primary outcome was the difference in the point prevalence incidence of ARIs between pilgrims in the randomised groups. A case of ARI was defined by applying broad clinical criteria, while possible influenza-like illnesses and COVID-19 were diagnosed by syndromic definitions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121894 0
Dr Harunor Rashid
Address 121894 0
National Centre for Immunisation Research and Surveillance (NCIRS)
Kids Research at The Children's Hospital at Westmead
& Sydney Infectious Diseases Institute
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001, Westmead NSW 2145, Australia

Westmead Hospital, Level 5, Block K , Westmead NSW 2145
Country 121894 0
Australia
Phone 121894 0
+61298451489
Fax 121894 0
+6129845 1418
Email 121894 0
harunor.rashid@health.nsw.gov.au
Contact person for public queries
Name 121895 0
Dr Harunor Rashid
Address 121895 0
National Centre for Immunisation Research and Surveillance (NCIRS)
Kids Research at The Children's Hospital at Westmead
& Sydney Infectious Diseases Institute
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001, Westmead NSW 2145, Australia

Westmead Hospital, Level 5, Block K , Westmead NSW 2145
Country 121895 0
Australia
Phone 121895 0
+61298451489
Fax 121895 0
+6129845 1418
Email 121895 0
harunor.rashid@health.nsw.gov.au
Contact person for scientific queries
Name 121896 0
Dr Harunor Rashid
Address 121896 0
National Centre for Immunisation Research and Surveillance (NCIRS)
Kids Research at The Children's Hospital at Westmead
& Sydney Infectious Diseases Institute
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001, Westmead NSW 2145, Australia

Westmead Hospital, Level 5, Block K , Westmead NSW 2145
Country 121896 0
Australia
Phone 121896 0
+61298451489
Fax 121896 0
+6129845 1418
Email 121896 0
harunor.rashid@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17181Study protocol    384709-(Uploaded-25-09-2022-15-53-40)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe relationship between hand hygiene and rates of acute respiratory infections among Umrah pilgrims: A pilot randomised controlled trial.2023https://dx.doi.org/10.1016/j.jiph.2023.04.003
N.B. These documents automatically identified may not have been verified by the study sponsor.