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NCT Number: NCT05539482

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.

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Key information

Conditions

COVID-19 Adherence Interventions Behavior Coronaviridae Infections Coronavirus Infections Health Behavior Health Education Infections Lung Diseases Medication Adherence Nidovirales Infections Patient Acceptance of Health Care Patient Compliance Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

Location status: Recruiting

Location contact

Yao Jie Xie, PhD

CONTACT

[email protected]

(852) 3400 3798

Yao Jie Xie, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Community-based Health Education based on core intervention package

Behavioral

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

  • 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.
  • 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.
  • 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 Group

Behavioral

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

Primary outcomes

  1. Vaccination rates

    Time frame: 3 months

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

Secondary outcomes

  1. The knowledge towards COVID-19 vaccine

    Time frame: 3 months

    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.

  2. The hesitancy towards COVID-19 vaccine

    Time frame: 3 months

    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.

  3. Perceived confidence of COVID-19 vaccine

    Time frame: 3 months

    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..

  4. Perceived barriers of receiving COVID-19 vaccine

    Time frame: 3 months

    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..

  5. The amount of early testing

    Time frame: 3 months

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

  6. The levels of acceptability for early testing

    Time frame: 3 months

    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.

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

    Time frame: 3 months

    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.

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

    Time frame: 3 months

    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.

  9. The knowledge of proper self-protection

    Time frame: 3 months

    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.

  10. Stress status

    Time frame: 3 months

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

  11. Anxiety status

    Time frame: 3 months

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

  12. Depression status

    Time frame: 3 months

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

  13. Participants' satisfactory level

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yao Jie Xie, PhD

CONTACT

[email protected]

3400 3798 ext. 852

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Food and Health Bureau, Hong Kong

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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