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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 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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05539482
Enrollment
1200
Registered
2022-09-14
Start date
2022-11-01
Completion date
2025-10-31
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

CBPR, health education, vaccination rate, early-testing, self-protection, Hong Kong residents

Brief 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. 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

BEHAVIORALCommunity-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 benefits and resources for vaccination. Collaborators should design and implement health programs based on the core intervention package.

BEHAVIORALHealth Information Sharing Group

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

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER
Food and Health Bureau, Hong Kong
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

All the participants will be blind to the allocation. Participants in the intervention group will receive intervention based on core package, while participants in the control will receive health information which are collected and provided by collaborators. The collaborator also will be told to avoid discussing allocation with the participants.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Vaccination rates3 monthsThe number of participants who received a new dose of COVID-19 vaccine over the total number of participants.

Secondary

MeasureTime frameDescription
The knowledge towards COVID-19 vaccine3 monthsThe 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.
The hesitancy towards COVID-19 vaccine3 monthsThe 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.
Perceived confidence of COVID-19 vaccine3 monthsThe 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..
Perceived barriers of receiving COVID-19 vaccine3 monthsThe 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..
The amount of early testing3 monthsThe amount of early testing will be measured by self-reported number of early-testing with rapid antigen testing (RAT) in a month.
The levels of acceptability for early testing3 monthsThe 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.
The frequency of washing hands with soap or hand sanitizer3 monthsThe 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.
The frequency of washing hands with alcohol-based hand rub3 monthsThe 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.
The knowledge of proper self-protection3 monthsThe 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.
Stress status3 monthsThe Perceived Stress Scale (PSS-4) will be used to measure the stress level.
Anxiety status3 monthsGeneralized Anxiety Disorder (GAD-2) will be used to measure the level of anxiety.
Depression status3 monthsThe Patient Health Questionnaire-2 (PHQ-2) will be used to measure the depression status.
Participants' satisfactory level3 monthsThe participants' satisfactory level will be measured by asking the degree of satisfaction (1-10) in terms of vaccination, early-testing and self-protection.

Countries

Hong Kong

Contacts

PRINCIPAL_INVESTIGATORYao Jie Xie, PhD

The Hong Kong Polytechnic University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026