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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: Community-based Health Education based on core intervention package; Behavioral: Health Information Sharing Group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yao Jie Xie, PhD; Phone Number: 852 3400 3798; Email: grace.yj.xie@poly.edu.hk

Study Locations

• Hong Kong
  • Hung Hom, Hong Kong
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Yao Jie Xie, PhD; Phone Number: (852) 3400 3798; Email: grace.yj.xie@polyu.edu.hk
    • Principal Investigator: Yao Jie Xie, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community-Based Health Education Group; 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.	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.
Active Comparator: Health Information Sharing Group; 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.	Behavioral: Health Information Sharing Group; Collaborators are encouraged to collect and share health information to the participants. Shared information should be previewed by researchers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccination rates	The number of participants who received a new dose of COVID-19 vaccine over the total number of participants.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
Stress status	The Perceived Stress Scale (PSS-4) will be used to measure the stress level.	3 months
Anxiety status	Generalized Anxiety Disorder (GAD-2) will be used to measure the level of anxiety.	3 months
Depression status	The Patient Health Questionnaire-2 (PHQ-2) will be used to measure the depression status.	3 months
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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Food and Health Bureau, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: health education; CBPR; vaccination rate; early-testing; self-protection; Hong Kong residents
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: P0039048; COVID1903006-A (Other Grant/Funding Number: HMRF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No