Communicating Human Papillomavirus Vaccine With Japanese Parents and Caregivers With Daughters Aged 12-18

NCT ID: NCT06347627

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-22

Study Completion Date

2024-12-31

Brief Summary

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This study aims to comprehensively assess confidence in and acceptance of human papillomavirus (HPV) vaccines among Japanese parents and caregivers with daughters aged 12-18 and their decision-making process.

Detailed Description

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This study will implement an experiment as a sixteen-arm randomized controlled trial in an online survey environment. Before the experiment, participants, who are Japanese caregivers with daughters aged 12-18 who have not received an HPV vaccine, will first answer a pre-experiment survey. The survey will collect information on participants' socio-demographic data and key decision-making factors for HPV vaccine acceptance and confidence. Then, the study will randomly assign the participants to view one digital communication message using a 2 × 2 × 2 × 2 between-person factorial experiment on 'components of message.' The sixteen experimental messages will be developed based on real social media messages posted between November 2021 and April 2022, when the Japanese government prepared to reinstate an active recommendation of HPV vaccines for eligible girls after eight and a half years of suspension.

The sixteen messages will assess four factors: messenger, style, content, and misinformation. Each message will be similar except for one variable in consideration. The messenger component will be whether the message is from an individual or an organization. As individual messengers, the study will set a fictional male or female with common Japanese names who actively communicate about HPV vaccines. As organizational messengers, the study will use the existing accounts of the Ministry of Health, Labour and Welfare or the Japan Cancer Society or a fictional account of an anti-vaccine group. The style component will be whether the message conveys information through storytelling or scientific data. Messages will include personal stories for the storytelling style and statistics for the scientific data style. The content component will be whether the message conveys information about the effectiveness of the HPV vaccine in preventing diseases or the safety of the HPV vaccine. The contents will be built on both factual information and misconceptions about HPV vaccine safety and effectiveness that are often mentioned in the actual social media posts. The misinformation component will be whether the message conveys misinformation or factual information. The study will debrief all respondents exposed to misinformation after the survey.

Lastly, the study will collect data as a post-experiment survey to evaluate how an online message influenced caregivers' trust, confidence, and motivation to vaccinate.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1 (I x S x S x F)

Participants in Group 1 will view a message in an X (former Twitter) format composed of "Individual x Safety x Storytelling x Factual" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 1 (I x S x S x F)

Intervention Type BEHAVIORAL

Experimental message: Individual x Safety x Storytelling x Factual

Group 2 (O x S x S x F)

Participants in Group 2 will view a message in an X (former Twitter) format composed of "Organization x Safety x Storytelling x Factual" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 2 (O x S x S x F)

Intervention Type BEHAVIORAL

Experimental message: Organization x Safety x Storytelling x Factual

Group 3 (I x E x S x F)

Participants in Group 3 will view a message in an X (former Twitter) format composed of "Individual x Effectiveness x Storytelling x Factual" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 3 (I x E x S x F)

Intervention Type BEHAVIORAL

Experimental message: Individual x Effectiveness x Storytelling x Factual

Group 4 (O x E x S x F)

Participants in Group 4 will view a message in an X (former Twitter) format composed of "Organization x Effectiveness x Storytelling x Factual" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 4 (O x E x S x F)

Intervention Type BEHAVIORAL

Experimental message: Organization x Effectiveness x Storytelling x Factual

Group 5 (I x S x S x M)

Participants in Group 5 will view a message in an X (former Twitter) format composed of "Individual x Safety x Storytelling x Misinformation" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 5 (I x S x S x M)

Intervention Type BEHAVIORAL

Experimental message: Individual x Safety x Storytelling x Misinformation

Group 6 (O x S x S x M)

Participants in Group 6 will view a message in an X (former Twitter) format composed of "Organization x Safety x Storytelling x Misinformation" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 6 (O x S x S x M)

Intervention Type BEHAVIORAL

Experimental message: Organization x Safety x Storytelling x Misinformation

Group 7 (I x E x S x M)

Participants in Group 7 will view a message in an X (former Twitter) format composed of "Individual x Effectiveness x Storytelling x Misinformation" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 7 (I x E x S x M)

Intervention Type BEHAVIORAL

Experimental message: Individual x Effectiveness x Storytelling x Misinformation

Group 8 (O x E x S x M)

Participants in Group 8 will view a message in an X (former Twitter) format composed of "Organization x Effectiveness x Storytelling x Misinformation" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 8 (O x E x S x M)

Intervention Type BEHAVIORAL

Experimental message: Organization x Effectiveness x Storytelling x Misinformation

Group 9 (I x S x D x F)

Participants in Group 9 will view a message in an X (former Twitter) format composed of "Individual x Safety x Scientific data x Factual" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 9 (I x S x D x F)

Intervention Type BEHAVIORAL

Experimental message: Individual x Safety x Scientific data x Factual

Group 10 (O x S x D x F)

Participants in Group 10 will view a message in an X (former Twitter) format composed of "Organization x Safety x Scientific data x Factual" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 10 (O x S x D x F)

Intervention Type BEHAVIORAL

Experimental message: Organization x Safety x Scientific data x Factual

Group 11 (I x E x D x F)

Participants in Group 11 will view a message in an X (former Twitter) format composed of "Individual x Effectiveness x Scientific data x Factual" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 11 (I x E x D x F)

Intervention Type BEHAVIORAL

Experimental message: Individual x Effectiveness x Scientific data x Factual

Group 12 (O x E x D x F)

Participants in Group 12 will view a message in an X (former Twitter) format composed of "Organization x Effectiveness x Scientific data x Factual" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 12 (O x E x D x F)

Intervention Type BEHAVIORAL

Experimental message: Organization x Effectiveness x Scientific data x Factual

Group 13 (I x S x D x M)

Participants in Group 13 will view a message in an X (former Twitter) format composed of "Individual x Safety x Scientific data x Misinformation" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 13 (I x S x D x M)

Intervention Type BEHAVIORAL

Experimental message: Individual x Safety x Scientific data x Misinformation

Group 14 (O x S x D x M)

Participants in Group 14 will view a message in an X (former Twitter) format composed of "Organization x Safety x Scientific data x Misinformation" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 14 (O x S x D x M)

Intervention Type BEHAVIORAL

Experimental message: Organization x Safety x Scientific data x Misinformation

Group 15 (I x E x D x M)

Participants in Group 15 will view a message in an X (former Twitter) format composed of "Individual x Effectiveness x Scientific data x Misinformation" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 15 (I x E x D x M)

Intervention Type BEHAVIORAL

Experimental message: Individual x Effectiveness x Scientific data x Misinformation

Group 16 (O x E x D x M)

Participants in Group 16 will view a message in an X (former Twitter) format composed of "Organization x Effectiveness x Scientific data x Misinformation" factors. The message will be available for participants to view while answering five questions that evaluate how it influenced caregivers' trust, confidence, and motivation to vaccinate.

Group Type EXPERIMENTAL

Group 16 (O x E x D x M)

Intervention Type BEHAVIORAL

Experimental message: Organization x Effectiveness x Scientific data x Misinformation

Interventions

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Group 1 (I x S x S x F)

Experimental message: Individual x Safety x Storytelling x Factual

Intervention Type BEHAVIORAL

Group 2 (O x S x S x F)

Experimental message: Organization x Safety x Storytelling x Factual

Intervention Type BEHAVIORAL

Group 3 (I x E x S x F)

Experimental message: Individual x Effectiveness x Storytelling x Factual

Intervention Type BEHAVIORAL

Group 4 (O x E x S x F)

Experimental message: Organization x Effectiveness x Storytelling x Factual

Intervention Type BEHAVIORAL

Group 5 (I x S x S x M)

Experimental message: Individual x Safety x Storytelling x Misinformation

Intervention Type BEHAVIORAL

Group 6 (O x S x S x M)

Experimental message: Organization x Safety x Storytelling x Misinformation

Intervention Type BEHAVIORAL

Group 7 (I x E x S x M)

Experimental message: Individual x Effectiveness x Storytelling x Misinformation

Intervention Type BEHAVIORAL

Group 8 (O x E x S x M)

Experimental message: Organization x Effectiveness x Storytelling x Misinformation

Intervention Type BEHAVIORAL

Group 9 (I x S x D x F)

Experimental message: Individual x Safety x Scientific data x Factual

Intervention Type BEHAVIORAL

Group 10 (O x S x D x F)

Experimental message: Organization x Safety x Scientific data x Factual

Intervention Type BEHAVIORAL

Group 11 (I x E x D x F)

Experimental message: Individual x Effectiveness x Scientific data x Factual

Intervention Type BEHAVIORAL

Group 12 (O x E x D x F)

Experimental message: Organization x Effectiveness x Scientific data x Factual

Intervention Type BEHAVIORAL

Group 13 (I x S x D x M)

Experimental message: Individual x Safety x Scientific data x Misinformation

Intervention Type BEHAVIORAL

Group 14 (O x S x D x M)

Experimental message: Organization x Safety x Scientific data x Misinformation

Intervention Type BEHAVIORAL

Group 15 (I x E x D x M)

Experimental message: Individual x Effectiveness x Scientific data x Misinformation

Intervention Type BEHAVIORAL

Group 16 (O x E x D x M)

Experimental message: Organization x Effectiveness x Scientific data x Misinformation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female adult caregivers, older than 20, with daughters aged 12-18 who have received none or only one shot of HPV vaccine.

Exclusion Criteria

* Caregivers who do not agree to participate in survey, experiment, or both.
* Caregivers with daughters who have already received two or more HPV vaccines.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Nagasaki University

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leesa Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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London School of Hygiene and Tropical Medicine

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Kobayashi K, Masuda K, Wu JT, Lin L. Impact of digital communication message on HPV vaccine decision-making among Japanese mothers: A randomized controlled trial. Vaccine. 2025 Aug 13;61:127327. doi: 10.1016/j.vaccine.2025.127327. Epub 2025 Jun 3.

Reference Type DERIVED
PMID: 40466485 (View on PubMed)

Other Identifiers

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UW23139

Identifier Type: -

Identifier Source: org_study_id

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