NCT05531058

Brief Summary

Vaccine hesitancy is defined as 'delay in acceptance or refusal of vaccines, despite the availability of vaccine service' and was named one of the top ten global health threats by the World Health Organization in 2019. Our proposed study will aim to develop and evaluate the effectiveness of a Web-based psychoeducation programme to address Covid-19 vaccine hesitancy, 'AI-driven Vaccine Communicator' (including educational materials, animations of vaccine research and development, and an MI communication skills-based AI, digital assistant). Our goal is to standardise our intervention so that it can serve as an effective toolkit for clinicians/healthcare providers to increase Hong Kong residents' motivation to vaccinate and to ensure that the programme can be adapted to viral mutations and newly developed vaccines in the medium/long term.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 11, 2025

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

August 28, 2022

Last Update Submit

March 6, 2025

Conditions

Keywords

Vaccine HesitancyCOVID-19Motivational InterventionAI ChatbotArtificial Intelligence

Outcome Measures

Primary Outcomes (4)

  • Vaccine hesitancy at pre-test

    Vaccine hesitancy measured by Adult Vaccine Hesitancy scale and a single question 'plan for next dose'

    Vaccine hesitancy will be assessed at pre-intervention.

  • Vaccine hesitancy at post-intervention

    Vaccine hesitancy measured by Adult Vaccine Hesitancy scale and a single question 'plan for next dose'

    Vaccine hesitancy will be assessed five weeks post the commencement of the intervention (at post-intervention).

  • Vaccine hesitancy at three months follow-up

    Vaccine hesitancy measured by Adult Vaccine Hesitancy scale and a single question 'plan for next dose'

    Vaccine hesitancy will be assessed after three months follow-up.

  • Vaccine hesitancy at six months follow-up

    Vaccine hesitancy measured by Adult Vaccine Hesitancy scale and a single question 'plan for next dose'

    Vaccine hesitancy will be assessed after six months follow-up.

Secondary Outcomes (16)

  • Vaccine confidence at pre-test

    Vaccine confidence will be assessed at pre-intervention.

  • Vaccine confidence at post-intervention

    Vaccine confidence will be assessed five weeks post the commencement of the intervention (at post-intervention).

  • Vaccine confidence at three months follow-up

    Vaccine confidence will be assessed after three months follow-up.

  • Vaccine confidence at six months follow-up

    Vaccine confidence will be assessed after six months follow-up.

  • Vaccine readiness at pre-test

    Vaccine readiness will be assessed at pre-intervention.

  • +11 more secondary outcomes

Study Arms (2)

AI-driven vaccine communicator intervention group

EXPERIMENTAL

The intervention will include five modules web-based psychoeducation programme (two modules sessions weekly, each module lasts for 15-20 minutes) which includes educational materials, animations of vaccine research and development, and an MI communication skills-based AI, digital assistant.

Behavioral: AI-driven Vaccine Communicator

Self-learning of COVID-19 vaccine knowledge control group

ACTIVE COMPARATOR

Participants in the control group will be given HK government websites in COVID-19 vaccine and invite to join the online examination in relation to Covid-19 vaccine knowledge.

Behavioral: Self-learning of COVID-19 vaccine knowledge

Interventions

The intervention will include five modules web-based psychoeducation programme (two module sessions weekly, each module lasts for 15-20 minutes) and interact with an MI communication skills-based AI, digital assistant.

AI-driven vaccine communicator intervention group

Participants in the control group will be given HK government websites in COVID-19 vaccine and invite to join the online examination in relation to Covid-19 vaccine knowledge (using multiple choices questions similar to the intervention group), and this is to ensure that participants from the control group also use time to search relevant information of covid-19 vaccines, also this is to control the time effects.

Self-learning of COVID-19 vaccine knowledge control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or above;
  • Hong Kong residents;
  • Show vaccine hesitancy (not taking COVID-19 vaccines or receiving involuntary COVID-19 vaccines);
  • have internet access
  • able to read Chinese or English. Recruitment involved social media promotion and collaborating with community organizations

You may not qualify if:

  • People with self-reported cognitive impairments or mental disorders that might interfere with their understanding of the intervention content;
  • People who currently engaged in another clinical trial in relation to Covid-19 vaccines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic Unviersity

Hong Kong, Hong Kong

Location

Related Publications (5)

  • Jarrett C, Wilson R, O'Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy. Strategies for addressing vaccine hesitancy - A systematic review. Vaccine. 2015 Aug 14;33(34):4180-90. doi: 10.1016/j.vaccine.2015.04.040. Epub 2015 Apr 18.

    PMID: 25896377BACKGROUND
  • MacDonald NE; SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161-4. doi: 10.1016/j.vaccine.2015.04.036. Epub 2015 Apr 17.

    PMID: 25896383BACKGROUND
  • Taylor S, Landry CA, Paluszek MM, Groenewoud R, Rachor GS, Asmundson GJG. A Proactive Approach for Managing COVID-19: The Importance of Understanding the Motivational Roots of Vaccination Hesitancy for SARS-CoV2. Front Psychol. 2020 Oct 19;11:575950. doi: 10.3389/fpsyg.2020.575950. eCollection 2020.

    PMID: 33192883BACKGROUND
  • Gagneur A, Lemaitre T, Gosselin V, Farrands A, Carrier N, Petit G, Valiquette L, De Wals P. A postpartum vaccination promotion intervention using motivational interviewing techniques improves short-term vaccine coverage: PromoVac study. BMC Public Health. 2018 Jun 28;18(1):811. doi: 10.1186/s12889-018-5724-y.

    PMID: 29954370BACKGROUND
  • Leung SF, Ma J, Russell J. Enhancing motivation to change in eating disorders with an online self-help program. Int J Ment Health Nurs. 2013 Aug;22(4):329-39. doi: 10.1111/j.1447-0349.2012.00870.x. Epub 2012 Aug 6.

    PMID: 22882349BACKGROUND

MeSH Terms

Conditions

Vaccination HesitancyCOVID-19

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yan Li, Dr

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: We aim to have two study group, including the AI-driven vaccine communicator intervention group and the self-learning of COVID-19 vaccine knowledge control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2022

First Posted

September 7, 2022

Study Start

October 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

March 11, 2025

Record last verified: 2022-08

Locations