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AzTrials

COVID-19NCT05539482

Community-Based Health Education Programs for the Early Detection of, and Vaccination Against, COVID-19 and the Adoption of Self-Protective Measures of Hong Kong Residents

A study testing Community-based Health Education based on core intervention package and Health Information Sharing Group in people with COVID-19, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the community-based health education program in improving early testing for COVID-19, increasing vaccination acceptability and enhancing emergency preparedness and self-protection measures against COVID-19 in HK. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Community-based Health Education based on core intervention package and Health Information Sharing Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteHong Kong
Study dates
1 Nov 2022to 31 Oct 2025
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 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

For participants recruited by NGOs and companies, the Inclusion Criteria will be:

  • HK resident aged 18 years or above;
  • Agreement to participate in the study and provide written informed consent.

The Exclusion Criteria will be:

  • Cognitive impairment that inhibits communication with the investigators;
  • Inability or unwillingness to provide written informed consent.

For participants recruited by schools, the Inclusion Criteria will be:

  • HK students aged 12 to 18 years and their parents.

The Exclusion Criteria will be:

  • Cannot provide written informed consent (or assent for the younger students).

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Hong Kong Polytechnic University

    Hung Hom

Other trials in Hong Kong

About this study

Official title: A Multicenter, Cluster-Randomized, Active-Controlled, Single-Blind Trial of Community-Based Health Education Programs for the Early Detection of, and Vaccination Against, COVID-19 and the Adoption of Self-Protective Measures of Hong Kong Residents

This study evaluates the community-based health education program in improving early testing for COVID-19, increasing vaccination acceptability and enhancing emergency preparedness and self-protection measures against COVID-19 in HK. We established a partnership with several local community stakeholders and they will be responsible for recruiting participants and implementing educational programs. Half of the community collaborators will receive the core intervention package, and use it as education material. The other half will be encouraged to self-collect and send health information to the participants.

Read the detailed description

This health education program is based on a Community-based Participants Research (CBPR) approach, which is a partnership approach that equitably involves community members and researchers in all aspects of the research process. Given the different cultural, professional or living background of Hong Kong residents, we think this simple, flexible and sustainable approach will effectively mitigate the COVID-19 risk in HK society,

An academic-community collaboration platform with several nongovernmental organizations (NGOs), companies and schools will be established before this study. They will work together to recruit participants, design and implement a series of educational programs aimed at controlling the spread of COVID-19 in the community.

Conditions
COVID-19
Being tested
Community-based Health Education based on core intervention package, Health Information Sharing Group
Keywords
CBPR, health education, vaccination rate, early-testing, self-protection, Hong Kong residents
Medical subject headings
COVID-19, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community-based Health Education based on core intervention packageBehavioural

    Community-based Health Education will potentially include the following three components:

    1. A manual of emergency preparedness and self-protection against COVID-19 infection. The main content will include hand washing, mask wearing and social distancing guidelines.
    2. Early testing. Participants will be trained on how to recognize the early symptoms of COVID-19 and appropriate practice to take in a response, and they will be provided with testing resources.
    3. Knowledge of vaccines and their benefits and resources for vaccination.

    Collaborators should design and implement health programs based on the core intervention package.

  • Health Information Sharing GroupBehavioural

    Collaborators are encouraged to collect and share health information to the participants. Shared information should be previewed by researchers.

Study groups in NCT05539482
Study groupRoleWhat they receive
Community-Based Health Education GroupExperimentalThe collaborators will design the Community-based education approach (based on the core intervention package). Collaborators will be required to submit a brief standardized proposal to the academic investigators for review and approval, to ensure that all intervention programs have the same core intervention content and can be implemented appropriately. Collaborators will be able to use any reasonable strategies, such as social media platforms, information technology, posters, leaflets, and videos, to implement the programs . The use of incentives will be encouraged to improve participation. Each programs will last for 3 months. A booster session will be conducted at the mid of the intervention.
Receives: Behavioral: Community-based Health Education based on core intervention package
Health Information Sharing GroupActive comparatorThe collaborators will design the community-based education approach and deliver health information to the participants. Researchers will provide some information, while collaborators need to self-collect the rest. Collaborators also need to submit a proposal to ensure the feasibility of intervention programs and the accuracy of health information. Collaborators can use any reasonable strategies to implement the programs . The use of incentives will be encouraged to improve participation. Each programs will last for 3 months. A booster session will be conducted at the mid of the intervention.
Receives: Behavioral: Health Information Sharing Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccination rates

    The number of participants who received a new dose of COVID-19 vaccine over the total number of participants.

    Measured: 3 months

Secondary outcomes (13)

  1. The knowledge towards COVID-19 vaccine

    The knowledge towards COVID-19 vaccine will be measured by 15 items in the self-administered questionnaire. All the items are binary- choice Items (1=Ture, 2= False). The total score ranged from 15 to 30 and a higher score indicates poorer knowledge towards COVID-19 vaccine.

    Measured: 3 months

  2. The hesitancy towards COVID-19 vaccine

    The hesitancy towards COVID-19 vaccine will be measured by Chinese version of adult Vaccine Hesitancy Scale (aVAS), which includes 10 items of 5-point Likert scale, ranging from least hesitant (1) to most hesitant (5). In total 3 of aVAS are negatively worded and 7 are positively worded. The total score of aVAS is 50 with a score higher than 25 indicated high vaccine hesitancy.

    Measured: 3 months

  3. Perceived confidence of COVID-19 vaccine

    The confidence of COVID-19 vaccine will be measured by 11 items with 5-point Likert scale with "strongly disagree", "disagree", "neither agree nor disagree", "agree" and "strongly agree". The total score ranges from 11 to 55 with higher score indicating higher confidence of COVID-19 vaccine..

    Measured: 3 months

  4. Perceived barriers of receiving COVID-19 vaccine

    The perceived barriers of COVID-19 vaccine will be measured by 4 items with 5-point Likert scale with "strongly disagree", "disagree", "neither agree nor disagree", "agree" and "strongly agree". The total score ranges from 4 to 20 with higher score indicating higher perceived barriers of COVID-19 vaccine..

    Measured: 3 months

  5. The amount of early testing

    The amount of early testing will be measured by self-reported number of early-testing with rapid antigen testing (RAT) in a month.

    Measured: 3 months

  6. The levels of acceptability for early testing

    The levels of acceptability for early testing will be measured by 3 items with 5-point Likert scale with "strongly disagree", "disagree", "neither agree nor disagree", "agree" and "strongly agree". The total score ranges from 3 to 15 with higher score indicating higher acceptability of early testing.

    Measured: 3 months

  7. The frequency of washing hands with soap or hand sanitizer

    The amount of early testing will be measured by self-reported number of hand-washing behaviors with soap or hand sanitizer per day in the past week.

    Measured: 3 months

  8. The frequency of washing hands with alcohol-based hand rub

    The amount of early testing will be measured by self-reported number of hand-washing behaviors with alcohol-based hand rub per day in the past week.

    Measured: 3 months

  9. The knowledge of proper self-protection

    The knowledge of proper self-protection correctly will be measured 13 items in the self-administered questionnaire. All the items are binary- choice Items (1=Ture, 2= False). The total score ranged from 13 to 26 and a higher score indicates poorer knowledge of self-protection.

    Measured: 3 months

  10. Stress status

    The Perceived Stress Scale (PSS-4) will be used to measure the stress level.

    Measured: 3 months

  11. Anxiety status

    Generalized Anxiety Disorder (GAD-2) will be used to measure the level of anxiety.

    Measured: 3 months

  12. Depression status

    The Patient Health Questionnaire-2 (PHQ-2) will be used to measure the depression status.

    Measured: 3 months

  13. Participants' satisfactory level

    The participants' satisfactory level will be measured by asking the degree of satisfaction (1-10) in terms of vaccination, early-testing and self-protection.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start1 Nov 2022
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

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
The participants recruited by one collaborator will be considered as one cluster. A research assistant will randomly assign the clusters from the NGOs, Schools, and Companies to either the intervention group or the active control group, respectively. After allocation, there will be four clusters in both the intervention and control groups from the NGOs, schools and companies, respectively. This will result in 3 × 4 = 12 clusters for each group (intervention/control). A active control group will be used instead of a standard control group to help motivate the collaborators to implement the program and to avoid a high participant dropout rate.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05539482
Sponsor's protocol ID
P0039048
Other IDs
COVID1903006-A
Status last verified
Sep 2026
First submitted
4 Sep 2022
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Constantin 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

Questions about this trial

What is this clinical trial studying?

A study testing Community-based Health Education based on core intervention package and Health Information Sharing Group in people with COVID-19, run by The Hong Kong Polytechnic University 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?

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 10 Sep 2026. 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?

Vaccination rates (time frame: 3 months). 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 NCT05539482, which also lists 1 linked publication.

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 10 Sep 2026.

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