Back to resultsCommunity-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
Primary Purpose
COVID-19
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Community-based Health Education based on core intervention package
Health Information Sharing Group
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring CBPR, health education, vaccination rate, early-testing, self-protection, Hong Kong residents
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).
Sites / Locations
- The Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Community-Based Health Education Group
Health Information Sharing Group
Arm Description
The 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.
The 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.
Outcomes
Primary Outcome Measures
Vaccination rates
The number of participants who received a new dose of COVID-19 vaccine over the total number of participants.
Secondary Outcome Measures
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.
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.
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..
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..
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.
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.
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.
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.
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.
Stress status
The Perceived Stress Scale (PSS-4) will be used to measure the stress level.
Anxiety status
Generalized Anxiety Disorder (GAD-2) will be used to measure the level of anxiety.
Depression status
The Patient Health Questionnaire-2 (PHQ-2) will be used to measure the depression status.
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.
Full Information
NCT ID
NCT05539482
First Posted
September 4, 2022
Last Updated
September 13, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
Food and Health Bureau, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05539482
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Food and Health Bureau, Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
CBPR, health education, vaccination rate, early-testing, self-protection, Hong Kong residents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
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.
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Community-Based Health Education Group
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Health Information Sharing Group
Arm Type
Active Comparator
Arm Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Community-based Health Education based on core intervention package
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Information Sharing Group
Intervention Description
Collaborators are encouraged to collect and share health information to the participants. Shared information should be previewed by researchers.
Primary Outcome Measure Information:
Title
Vaccination rates
Description
The number of participants who received a new dose of COVID-19 vaccine over the total number of participants.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The knowledge towards COVID-19 vaccine
Description
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.
Time Frame
3 months
Title
The hesitancy towards COVID-19 vaccine
Description
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.
Time Frame
3 months
Title
Perceived confidence of COVID-19 vaccine
Description
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..
Time Frame
3 months
Title
Perceived barriers of receiving COVID-19 vaccine
Description
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..
Time Frame
3 months
Title
The amount of early testing
Description
The amount of early testing will be measured by self-reported number of early-testing with rapid antigen testing (RAT) in a month.
Time Frame
3 months
Title
The levels of acceptability for early testing
Description
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.
Time Frame
3 months
Title
The frequency of washing hands with soap or hand sanitizer
Description
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.
Time Frame
3 months
Title
The frequency of washing hands with alcohol-based hand rub
Description
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.
Time Frame
3 months
Title
The knowledge of proper self-protection
Description
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.
Time Frame
3 months
Title
Stress status
Description
The Perceived Stress Scale (PSS-4) will be used to measure the stress level.
Time Frame
3 months
Title
Anxiety status
Description
Generalized Anxiety Disorder (GAD-2) will be used to measure the level of anxiety.
Time Frame
3 months
Title
Depression status
Description
The Patient Health Questionnaire-2 (PHQ-2) will be used to measure the depression status.
Time Frame
3 months
Title
Participants' satisfactory level
Description
The participants' satisfactory level will be measured by asking the degree of satisfaction (1-10) in terms of vaccination, early-testing and self-protection.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Jie Xie, PhD
Phone
3400 3798
Ext
852
Email
grace.yj.xie@poly.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yao Jie Xie, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hung Hom
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Jie Xie, PhD
Phone
(852) 3400 3798
Email
grace.yj.xie@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Yao Jie Xie, PhD
12. IPD Sharing Statement
Learn more about this trial
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
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