NCT05539482

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Nov 2022

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

September 4, 2022

Last Update Submit

April 1, 2025

Conditions

Keywords

CBPRhealth educationvaccination rateearly-testingself-protectionHong Kong residents

Outcome Measures

Primary Outcomes (1)

  • Vaccination rates

    The number of participants who received a new dose of COVID-19 vaccine over the total number of participants.

    3 months

Secondary Outcomes (13)

  • The knowledge towards COVID-19 vaccine

    3 months

  • The hesitancy towards COVID-19 vaccine

    3 months

  • Perceived confidence of COVID-19 vaccine

    3 months

  • Perceived barriers of receiving COVID-19 vaccine

    3 months

  • The amount of early testing

    3 months

  • +8 more secondary outcomes

Study Arms (2)

Community-Based Health Education Group

EXPERIMENTAL

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

Health Information Sharing Group

ACTIVE COMPARATOR

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

Interventions

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.

Community-Based Health Education Group

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

Health Information Sharing Group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HK resident aged 18 years or above;
  • Agreement to participate in the study and provide written informed consent.

You may not qualify if:

  • Cognitive impairment that inhibits communication with the investigators;
  • Inability or unwillingness to provide written informed consent.
  • HK students aged 12 to 18 years and their parents.
  • Cannot provide written informed consent (or assent for the younger students).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

RECRUITING

Related Publications (1)

  • Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.

MeSH Terms

Conditions

COVID-19Health Education

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Yao Jie Xie, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Jie Xie, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 4, 2022

First Posted

September 14, 2022

Study Start

November 1, 2022

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

April 3, 2025

Record last verified: 2025-04

Locations