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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539482
• Other study ID #: P0039048
• Secondary ID: COVID1903006-A
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 2025

Study information

• Verified date: September 2022
• Source: The Hong Kong Polytechnic University
• Contact: Yao Jie Xie, PhD
• Phone: 3400 3798
• Email: grace.yj.xie[@]poly.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hung Hom

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Food and Health Bureau, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccination rates	The number of participants who received a new dose of COVID-19 vaccine over the total number of participants.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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..	3 months
Secondary	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..	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Stress status	The Perceived Stress Scale (PSS-4) will be used to measure the stress level.	3 months
Secondary	Anxiety status	Generalized Anxiety Disorder (GAD-2) will be used to measure the level of anxiety.	3 months
Secondary	Depression status	The Patient Health Questionnaire-2 (PHQ-2) will be used to measure the depression status.	3 months
Secondary	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.	3 months