Clinical trial NCT05197673: Identifying Risks of COVID-19 Outbreaks in Work Settings and the Implications for Control Measures
Official title: Identifying Risks of Outbreaks in Work Settings and the Implications for Control Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intention to Get SARS-CoV-2 Vaccination
Intention to Get SARS-CoV-2 Antibody Test
Keywords: workplace hazards
exposure prevention
vaccination
SARS-CoV-2
control measures
willingness
attitude
antibody testing
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group will receive theory-based educational intervention using the Theory of Planned Behaviours (TPB) PLUS general health information; Control group will receive only general health information.
Primary purpose: PREVENTION

Brief summary: Objectives: To identify core and cross-time workplace hazards and worker's exposure prevention profile towards outbreaks in three non-healthcare work settings; to evaluate effectiveness of a theory-based educational programme on improving attitude to vaccination and virus testing in workplace; to longitudinally compare attitude of willingness to vaccination, testing of SARS-CoV-2 and changes of risk profile toward outbreaks among workers.

Design: A 5-year study comprising a randomized controlled trial (RCT) and 3 parallel longitudinal studies with baseline and follow-up repeated measurements.

Setting: Non-office, mobile and office work settings. Participants: Part I is a RCT, 294 workers will be randomised to an intervention group (a theory-based education programme) and a control group with measurements repeated at 3rd, 6th and 9th month. Part II is a longitudinal quantitative study (i.e., prospective cohort study) involving 1,495 workers recruited at the baseline and followed up for 2 years. Part III is a longitudinal qualitative study involving 26 management and frontline workers. Part IV is a longitudinal workplace hygiene study involving 6 workplaces enrolled at the baseline and followed up to conduct ventilation investigation.

Intervention: Theory-based education intervention to build positive attitude of control measures towards SARS-CoV-2 outbreak.

Main outcome measure: Workplace hygiene data (airflow, air volume, etc.); willingness to vaccination and virus tests; actual uptake of SARS-CoV-2 antibody testing.

Data analyses: Multivariate regression logistic model and thematically analysed will be performed for quantitative and qualitative analysis. Intention-to-treat analysis will be employed for RCT.

Expected results: Large dataset of longitudinal measurement of willingness to vaccination/testing and actual uptake will be documented to inform policy. Educational intervention will be developed to mitigate risks of outbreaks in workplace.


Eligibility criteria: Inclusion Criteria:

* currently being employed in Hong Kong

Exclusion Criteria:

* who have history of physician-diagnosed cancer and sever chronic diseases

Primary outcomes:
measure: Change of intention to get vaccination of SARS-CoV-2
timeFrame: 3rd, 6th and 9th month
Secondary outcomes:
measure: Change of intention to uptake SARS-CoV-2 antibody test
timeFrame: 3rd, 6th and 9th month
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Lap Ah Tse
role: PRINCIPAL_INVESTIGATOR
References: