None listed
Conditions
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.
Interventions
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 Cosmet
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 .
Sponsors
Sydney Infectious Diseases Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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
Outcome results
None listed