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

Healthy Clinical Trial

Official title:

Communicating Human Papillomavirus Vaccine With Japanese Parents and Caregivers With Daughters Aged 12-18: a Mixed-methods Assessment of Acceptance of HPV Vaccine With Experiments on Communication Strategies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06347627
• Other study ID #: UW23139
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 22, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1600
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Group 1 (I x S x S x F)
Experimental message: Individual x Safety x Storytelling x Factual
• Group 2 (O x S x S x F)
Experimental message: Organization x Safety x Storytelling x Factual
• Group 3 (I x E x S x F)
Experimental message: Individual x Effectiveness x Storytelling x Factual
• Group 4 (O x E x S x F)
Experimental message: Organization x Effectiveness x Storytelling x Factual
• Group 5 (I x S x S x M)
Experimental message: Individual x Safety x Storytelling x Misinformation
• Group 6 (O x S x S x M)
Experimental message: Organization x Safety x Storytelling x Misinformation
• Group 7 (I x E x S x M)
Experimental message: Individual x Effectiveness x Storytelling x Misinformation
• Group 8 (O x E x S x M)
Experimental message: Organization x Effectiveness x Storytelling x Misinformation
• Group 9 (I x S x D x F)
Experimental message: Individual x Safety x Scientific data x Factual
• Group 10 (O x S x D x F)
Experimental message: Organization x Safety x Scientific data x Factual
• Group 11 (I x E x D x F)
Experimental message: Individual x Effectiveness x Scientific data x Factual
• Group 12 (O x E x D x F)
Experimental message: Organization x Effectiveness x Scientific data x Factual
• Group 13 (I x S x D x M)
Experimental message: Individual x Safety x Scientific data x Misinformation
• Group 14 (O x S x D x M)
Experimental message: Organization x Safety x Scientific data x Misinformation
• Group 15 (I x E x D x M)
Experimental message: Individual x Effectiveness x Scientific data x Misinformation
• Group 16 (O x E x D x M)
Experimental message: Organization x Effectiveness x Scientific data x Misinformation

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene and Tropical Medicine	London

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	London School of Hygiene and Tropical Medicine, Nagasaki University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Confidence in HPV vaccine safety	A degree of a change in confidence regarding HPV vaccine safety after viewing an experimental message will be scored on a 5-point scale. The options are 1) much less confident that the HPV vaccine is safe, 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.