NCT06347627

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

December 22, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 4, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

March 17, 2024

Last Update Submit

April 2, 2024

Conditions

Keywords

HPV Vaccine

Outcome Measures

Primary Outcomes (1)

  • Willingness to receive HPV vaccines for daughters

    A degree of a change in willingness to receive HPV vaccines after viewing an experimental message will be scored on a 5-point scale. The options are 1) much less willing to get the HPV vaccine for my daughter, 2) somewhat less, 3) neither more or less, 4) somewhat more, and 5) much more, with higher scores indicating a better outcome.

    This experiment is expected to take 20-30 minutes to complete. The study will assess the outcome measure immediately after participants are exposed to the experimental messages.

Secondary Outcomes (1)

  • Confidence in HPV vaccine safety

    This experiment is expected to take 20-30 minutes to complete. The study will assess the outcome measure immediately after participants are exposed to the experimental messages.

Study Arms (16)

Group 1 (I x S x S x F)

EXPERIMENTAL

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.

Behavioral: Group 1 (I x S x S x F)

Group 2 (O x S x S x F)

EXPERIMENTAL

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.

Behavioral: Group 2 (O x S x S x F)

Group 3 (I x E x S x F)

EXPERIMENTAL

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.

Behavioral: Group 3 (I x E x S x F)

Group 4 (O x E x S x F)

EXPERIMENTAL

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.

Behavioral: Group 4 (O x E x S x F)

Group 5 (I x S x S x M)

EXPERIMENTAL

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.

Behavioral: Group 5 (I x S x S x M)

Group 6 (O x S x S x M)

EXPERIMENTAL

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.

Behavioral: Group 6 (O x S x S x M)

Group 7 (I x E x S x M)

EXPERIMENTAL

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.

Behavioral: Group 7 (I x E x S x M)

Group 8 (O x E x S x M)

EXPERIMENTAL

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.

Behavioral: Group 8 (O x E x S x M)

Group 9 (I x S x D x F)

EXPERIMENTAL

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.

Behavioral: Group 9 (I x S x D x F)

Group 10 (O x S x D x F)

EXPERIMENTAL

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.

Behavioral: Group 10 (O x S x D x F)

Group 11 (I x E x D x F)

EXPERIMENTAL

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.

Behavioral: Group 11 (I x E x D x F)

Group 12 (O x E x D x F)

EXPERIMENTAL

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.

Behavioral: Group 12 (O x E x D x F)

Group 13 (I x S x D x M)

EXPERIMENTAL

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.

Behavioral: Group 13 (I x S x D x M)

Group 14 (O x S x D x M)

EXPERIMENTAL

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.

Behavioral: Group 14 (O x S x D x M)

Group 15 (I x E x D x M)

EXPERIMENTAL

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.

Behavioral: Group 15 (I x E x D x M)

Group 16 (O x E x D x M)

EXPERIMENTAL

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.

Behavioral: Group 16 (O x E x D x M)

Interventions

Experimental message: Individual x Safety x Storytelling x Factual

Group 1 (I x S x S x F)

Experimental message: Organization x Safety x Storytelling x Factual

Group 2 (O x S x S x F)

Experimental message: Individual x Effectiveness x Storytelling x Factual

Group 3 (I x E x S x F)

Experimental message: Organization x Effectiveness x Storytelling x Factual

Group 4 (O x E x S x F)

Experimental message: Individual x Safety x Storytelling x Misinformation

Group 5 (I x S x S x M)

Experimental message: Organization x Safety x Storytelling x Misinformation

Group 6 (O x S x S x M)

Experimental message: Individual x Effectiveness x Storytelling x Misinformation

Group 7 (I x E x S x M)

Experimental message: Organization x Effectiveness x Storytelling x Misinformation

Group 8 (O x E x S x M)

Experimental message: Individual x Safety x Scientific data x Factual

Group 9 (I x S x D x F)

Experimental message: Organization x Safety x Scientific data x Factual

Group 10 (O x S x D x F)

Experimental message: Individual x Effectiveness x Scientific data x Factual

Group 11 (I x E x D x F)

Experimental message: Organization x Effectiveness x Scientific data x Factual

Group 12 (O x E x D x F)

Experimental message: Individual x Safety x Scientific data x Misinformation

Group 13 (I x S x D x M)

Experimental message: Organization x Safety x Scientific data x Misinformation

Group 14 (O x S x D x M)

Experimental message: Individual x Effectiveness x Scientific data x Misinformation

Group 15 (I x E x D x M)

Experimental message: Organization x Effectiveness x Scientific data x Misinformation

Group 16 (O x E x D x M)

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London School of Hygiene and Tropical Medicine

London, United Kingdom

Location

Related Publications (1)

  • 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.

Study Officials

  • Leesa Lin, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2024

First Posted

April 4, 2024

Study Start

December 22, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 4, 2024

Record last verified: 2024-03

Locations