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Recruiting 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

No phase Interventional COVID-19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Community-based Health Education based on core intervention package, Health Information Sharing Group.
Who it may be relevant to
Registry conditions: COVID-19. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Interventions

  • Behavioral Community-based Health Education based on core intervention package
    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 b
  • Behavioral Health Information Sharing Group
    Collaborators are encouraged to collect and share health information to the participants. Shared information should be previewed by researchers.

Primary outcome measures

  • Vaccination rates [Time frame: 3 months]
Secondary outcome measures (12)
  • The knowledge towards COVID-19 vaccine [Time frame: 3 months]
  • The hesitancy towards COVID-19 vaccine [Time frame: 3 months]
  • Perceived confidence of COVID-19 vaccine [Time frame: 3 months]
  • Perceived barriers of receiving COVID-19 vaccine [Time frame: 3 months]
  • The amount of early testing [Time frame: 3 months]
  • The levels of acceptability for early testing [Time frame: 3 months]
  • The frequency of washing hands with soap or hand sanitizer [Time frame: 3 months]
  • The frequency of washing hands with alcohol-based hand rub [Time frame: 3 months]
  • The knowledge of proper self-protection [Time frame: 3 months]
  • Stress status [Time frame: 3 months]
  • Anxiety status [Time frame: 3 months]
  • Depression status [Time frame: 3 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hung Hom

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. PMID 38597249

Identifiers

NCT: NCT05539482 · P0039048 · COVID1903006-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗