Intention to Get SARS-CoV-2 VaccinationNCT05197673
Identifying Risks of COVID-19 Outbreaks in Work Settings and the Implications for Control Measures
A study testing Theory of planned behaviours (TPB) based intervention in people with Intention to Get SARS-CoV-2 Vaccination and Intention to Get SARS-CoV-2 Antibody Test, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intention to Get SARS-CoV-2 Vaccination, Intention to Get SARS-CoV-2 Antibody Test
- What is being tested?
- Theory of planned behaviours (TPB) based intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Mar 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- currently being employed in Hong Kong
Who cannot join
- who have history of physician-diagnosed cancer and sever chronic diseases
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong
Shatin, New Territories, 00000
About this study
Official title: Identifying Risks of Outbreaks in Work Settings and the Implications for Control Measures
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.
Read more
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.
- Being tested
- Theory of planned behaviours (TPB) based intervention
- Keywords
- workplace hazards, exposure prevention, vaccination, SARS-CoV-2, control measures, willingness, attitude, antibody testing
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory of planned behaviours (TPB) based interventionBehavioural
Intervention group will receive TPB-based education program to improve workers' attitude toward SARS-CoV-2 and raise their intention to vaccination and virus testing. The intervention will be implemented at the baseline with measurements repeated at the 3rd month, 6th month and 9th month. The standardized mode of intervention includes face-to-face/online seminar (depends on the COVID-19 situation), message via mobile phone, promotion pamphlet, etc.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This arm will receive TPB intervention to build positive attitudes towards COVID-19 related preventive behaviour (e.g., good compliance with infection control measures, encouraging uptake of testing and vaccination), subjective norms (tackling strategies for perceived social pressure from others or normative beliefs), and improve perceived behavioural control towards risks of outbreaks in workplace. Receives: Behavioral: Theory of planned behaviours (TPB) based intervention |
| Control group | No intervention | Control group will receive only general health information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of intention to get vaccination of SARS-CoV-2
A questionnaire will be used to evaluate the intention to get vaccination quantitively. This assessment will be repeated in the 3rd, 6th and 9th month. Change will be assessed among these time points.
Measured: 3rd, 6th and 9th month
Secondary outcomes (1)
Change of intention to uptake SARS-CoV-2 antibody test
A questionnaire will be used to evaluate the intention to get rapid antibody test quantitively. This assessment will be repeated in the 3rd, 6th and 9th month. Change will be assessed among these time points.
Measured: 3rd, 6th and 9th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start15 Mar 2022
- Primary completion30 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intention to Get SARS-CoV-2 VaccinationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tse Lap Ah, Chinese University of Hong Kong
- Investigators
- Lap Ah Tse, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197673
- Sponsor's protocol ID
- 2021.531-T
- Status last verified
- Feb 2024
- First submitted
- 30 Nov 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tse LA, Wang F, Mo PKH, Wan CCM, Tang NHY, Yang S, Dong D, Ho KF, Wong SY. Does enhanced educational intervention reduce breakthrough infection and mental health problems via improving acceptance of COVID-19 booster shots in Chinese non-healthcare workers: A randomized controlled trial? J Infect Public Health. 2025 May;18(5):102719. doi: 10.1016/j.jiph.2025.102719. Epub 2025 Feb 21.
PubMed 40056893Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
PubMed 38597249
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Risks of Outbreaks in Work Settings and the Implications for Control Measures
- ClinicalTrials.gov ID
- NCT05197673
- Acronym / sponsor ID
- 2021.531-T
- Keywords
- workplace hazards, exposure prevention, vaccination, SARS-CoV-2, control measures, willingness, attitude, antibody testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Theory of planned behaviours (TPB) based interventionThis arm will receive TPB intervention to build positive attitudes towards COVID-19 related preventive behaviour (e.g., good compliance with infection control measures, encouraging uptake of testing and vaccination), subjective norms (tackling strategies for perceived social pressure from others or normative beliefs), and improve perceived behavioural control towards risks of outbreaks in workplace. |
| Control group | No intervention | –Control group will receive only general health information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- currently being employed in Hong Kong
Key exclusion criteria (1 listed)
- who have history of physician-diagnosed cancer and sever chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theory of planned behaviours (TPB) based interventionIntervention group will receive TPB-based education program to improve workers' attitude toward SARS-CoV-2 and raise their intention to vaccination and virus testing. The intervention will be implemented at the baseline with measurements repeated at the 3rd month, 6th month and 9th month. The standardized mode of intervention includes face-to-face/online seminar (depends on the COVID-19 situation), message via mobile phone, promotion pamphlet, etc. | Behavioural | Intervention group |
Primary outcome
Change of intention to get vaccination of SARS-CoV-2
Time frame: 3rd, 6th and 9th month
A questionnaire will be used to evaluate the intention to get vaccination quantitively. This assessment will be repeated in the 3rd, 6th and 9th month. Change will be assessed among these time points.
1 secondary outcome
Change of intention to uptake SARS-CoV-2 antibody test
Time frame: 3rd, 6th and 9th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 40056893Tse LA, Wang F, Mo PKH, Wan CCM, Tang NHY, Yang S, Dong D, Ho KF, Wong SY. Does enhanced educational intervention reduce breakthrough infection and mental health problems via improving acceptance of COVID-19 booster shots in Chinese non-healthcare workers: A randomized controlled trial? J Infect Public Health. 2025 May;18(5):102719. doi: 10.1016/j.jiph.2025.102719. Epub 2025 Feb 21.
- Derived from this study: PubMed 38597249Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lap Ah Tse principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory of planned behaviours (TPB) based intervention in people with Intention to Get SARS-CoV-2 Vaccination and Intention to Get SARS-CoV-2 Antibody Test, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of intention to get vaccination of SARS-CoV-2 (time frame: 3rd, 6th and 9th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197673, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.