Clinical trial 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
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
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: CBPR
health education
vaccination rate
early-testing
self-protection
Hong Kong residents
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
First posted: 2022-09-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Vaccination rates
timeFrame: 3 months
Secondary outcomes:
measure: The knowledge towards COVID-19 vaccine
timeFrame: 3 months
measure: The hesitancy towards COVID-19 vaccine
timeFrame: 3 months
measure: Perceived confidence of COVID-19 vaccine
timeFrame: 3 months
measure: Perceived barriers of receiving COVID-19 vaccine
timeFrame: 3 months
measure: The amount of early testing
timeFrame: 3 months
measure: The levels of acceptability for early testing
timeFrame: 3 months
measure: The frequency of washing hands with soap or hand sanitizer
timeFrame: 3 months
measure: The frequency of washing hands with alcohol-based hand rub
timeFrame: 3 months
measure: The knowledge of proper self-protection
timeFrame: 3 months
measure: Stress status
timeFrame: 3 months
measure: Anxiety status
timeFrame: 3 months
measure: Depression status
timeFrame: 3 months
measure: Participants' satisfactory level
timeFrame: 3 months
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yao Jie Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References: