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Vaccine HesitancyNCT05531058

The Impact of a Web-based Psychoeducation Programme with a Motivational AI Chatbot on Covid-19 Vaccine Hesitancy

A study testing AI-driven Vaccine Communicator and Self-learning of COVID-19 vaccine knowledge in people with Vaccine Hesitancy and COVID-19, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Vaccine Hesitancy, COVID-19
What is being tested?
AI-driven Vaccine Communicator and Self-learning of COVID-19 vaccine knowledge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteHong Kong
Study dates
1 Oct 2022to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • School of Nursing, The Hong Kong Polytechnic Unviersity

    Hong Kong

Other trials in Hong Kong

About this study

Official title: [AI-driven Vaccine Communicator: the Impact of a Web-based Psychoeducation Programme with a Motivational AI-based Digital Assistant on Covid-19 Vaccine Hesitancy in Hong Kong's Population

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.

Read the detailed description

This study is a two-arm, single-blind pilot randomized controlled trial, and it will be adopted to evaluate the efficacy of the 'AI-driven Vaccine Communicator' relative to being self-informed about Covid-19 vaccines.

Also, to address the widespread hesitancy among Hong Kong residents toward Covid-19 vaccines, we will develop a Web-based psychoeducation programme, 'AI-driven Vaccine Communicator,' driven by artificial intelligence (AI) techniques based on the Vaccine Hesitancy Determinants Matrix Model and MI communication skills and concepts (theoretical underpinnings). After developing and piloting this programme, we will test its effectiveness among members of the population who are hesitant about Covid-19 vaccines. The programme will then be refined further and standardised to use the most relevant information and effective communication skills to promote acceptance of Covid-19 vaccines among a wider Hong Kong population. Clinicians and healthcare providers will be able to utilise our programme as a toolkit in their usual practice when working with clients who are hesitant about Covid-19 vaccines.

Being tested
AI-driven Vaccine Communicator, Self-learning of COVID-19 vaccine knowledge
Keywords
Vaccine Hesitancy, COVID-19, Motivational Intervention, AI Chatbot, Artificial Intelligence
Medical subject headings
Vaccination Hesitancy, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-driven Vaccine CommunicatorBehavioural

    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.

  • Self-learning of COVID-19 vaccine knowledgeBehavioural

    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.

Study groups in NCT05531058
Study groupRoleWhat they receive
AI-driven vaccine communicator intervention groupExperimentalThe 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.
Receives: Behavioral: AI-driven Vaccine Communicator
Self-learning of COVID-19 vaccine knowledge control groupActive comparatorParticipants 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.
Receives: Behavioral: Self-learning of COVID-19 vaccine knowledge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccine hesitancy at pre-test

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

    Measured: Vaccine hesitancy will be assessed at pre-intervention.

  2. Vaccine hesitancy at post-intervention

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

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

  3. Vaccine hesitancy at three months follow-up

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

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

  4. Vaccine hesitancy at six months follow-up

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

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

Secondary outcomes (16)
  1. Vaccine confidence at pre-test

    Vaccine confidence assessed by Vaccine Confidence Index scale

    Measured: Vaccine confidence will be assessed at pre-intervention.

  2. Vaccine confidence at post-intervention

    Vaccine confidence assessed by Vaccine Confidence Index scale

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

  3. Vaccine confidence at three months follow-up

    Vaccine confidence assessed by Vaccine Confidence Index scale

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

  4. Vaccine confidence at six months follow-up

    Vaccine confidence assessed by Vaccine Confidence Index scale

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

  5. Vaccine readiness at pre-test

    Participants' perception of their degree of attitudinal change using three one-item measures of readiness for vaccine perception: How important is it for you to receive a COVID-19 vaccine?; How ready are you to receive a COVID-19 vaccine?; How confident are you about receiving a COVID-19 vaccine?

    Measured: Vaccine readiness will be assessed at pre-intervention.

  6. Vaccine readiness at post-intervention

    Participants' perception of their degree of attitudinal change using three one-item measures of readiness for vaccine perception: How important is it for you to receive a COVID-19 vaccine?; How ready are you to receive a COVID-19 vaccine?; How confident are you about receiving a COVID-19 vaccine?

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

  7. Vaccine readiness at three months follow up

    Participants' perception of their degree of attitudinal change using three one-item measures of readiness for vaccine perception: How important is it for you to receive a COVID-19 vaccine?; How ready are you to receive a COVID-19 vaccine?; How confident are you about receiving a COVID-19 vaccine?

    Measured: Vaccine readiness will be assessed after three months follow-up.

  8. Vaccine readiness at six months follow up

    Participants' perception of their degree of attitudinal change using three one-item measures of readiness for vaccine perception: How important is it for you to receive a COVID-19 vaccine?; How ready are you to receive a COVID-19 vaccine?; How confident are you about receiving a COVID-19 vaccine?

    Measured: Vaccine readiness will be assessed after six months follow-up.

  9. Vaccine-Related Health Literacy at pre-test

    Vaccine-Related Health Literacy assessed by Chinese version of the European Health Literacy Survey Questionnaire

    Measured: Vaccine-Related Health Literacy will be assessed at pre-intervention.

  10. Vaccine-Related Health Literacy at post-intervention

    Vaccine-Related Health Literacy assessed by Chinese version of the European Health Literacy Survey Questionnaire

    Measured: Vaccine-Related Health Literacy will be assessed five weeks post the commencement of the intervention (at post-intervention).

  11. Vaccine-Related Health Literacy at three months follow up

    Vaccine-Related Health Literacy assessed by Chinese version of the European Health Literacy Survey Questionnaire

    Measured: Vaccine-Related Health Literacy will be assessed after three months follow-up.

  12. Vaccine-Related Health Literacy at six months follow up

    Vaccine-Related Health Literacy assessed by Chinese version of the European Health Literacy Survey Questionnaire

    Measured: Vaccine-Related Health Literacy will be assessed after six months follow-up.

  13. Trust in government at pre-test

    Trust in government will be measured with the four-item Vaccine Confidence Index.

    Measured: Trust in government will be assessed at pre-intervention.

  14. Trust in government at post-test

    Trust in government will be measured with the four-item Vaccine Confidence Index.

    Measured: Trust in government will be assessed five weeks post the commencement of the intervention (at post-intervention).

  15. Trust in government at three-months follow up

    Trust in government will be measured with the four-item Vaccine Confidence Index.

    Measured: Trust in government will be assessed after three-months follow up.

  16. Trust in government at six-months follow up

    Trust in government will be measured with the four-item Vaccine Confidence Index.

    Measured: Trust in government will be assessed after six-months follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2022
  2. Study start1 Oct 2022
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05531058
Sponsor's protocol ID
P0039051
Status last verified
Aug 2022
First submitted
28 Aug 2022
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25896377
  • 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.

    PubMed 25896383
  • 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.

    PubMed 33192883
  • 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.

    PubMed 29954370
  • 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.

    PubMed 22882349

Questions about this trial

What is this clinical trial studying?

A study testing AI-driven Vaccine Communicator and Self-learning of COVID-19 vaccine knowledge in people with Vaccine Hesitancy and COVID-19, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccine hesitancy at pre-test (time frame: Vaccine hesitancy will be assessed at pre-intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05531058, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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