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OpenTrials
Completed

NCT Number: NCT06702423

AI Chatbot for HPV Vaccine Literacy Among Caregivers in Japan

The goal of this study is to learn if an innovative digital artificial intelligence (AI)-based communication tool works to enhance health literacy among Japanese caregivers regarding Human Papillomavirus (HPV) vaccination.

Participants will:

* Answer a pre-intervention survey, get information regarding HPV vaccination from an AI-based chatbot or leaflet, and answer a post-intervention survey. * Continue interacting with the chatbot or leaflet for two weeks. * Answer a follow-up survey.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

London School of Hygiene and Tropical Medicine

London, United Kingdom

About this study

This study will evaluate the efficacy and feasibility of an AI-driven chatbot in enhancing caregivers' health literacy about HPV vaccination and examines its impact on informed decision-making concerning their daughters' vaccination through a randomized controlled trial (RCT). To achieve this, the study will undertake the following interconnected activities:

  • Randomized Controlled Trial Participants will be randomly assigned to either the control or intervention group. Those in the control group will spend 5-10 minutes reading a publicly accessible HPV vaccination leaflet prepared by the MHLW, serving as the standard of care. Conversely, participants in the intervention group will be invited to interact with the chatbot for 5-10 minutes, posing inquiries (n>10) about HPV vaccination policies and related topics in Japan. Pre- and post-intervention assessments, as detailed below, will be administered to evaluate the chatbot's effectiveness and feasibility to counter HPV vaccine misinformation and support caregivers' vaccination decision-making processes.
  • Pre- and post-intervention assessments Following informed consent and enrollment, participants will complete a pre-intervention survey to establish baseline data. Post-intervention survey will be introduced at two touchpoints: the first is directly after spending time with either a leaflet (control) or a chatbot (intervention), and the second is two weeks after the first touchpoint.

The surveys are designed to assess the chatbot's effectiveness in enhancing caregivers' digital health literacy about HPV vaccination and facilitating informed vaccine decision-making.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A nationally representative sample of female caregivers with daughters aged 12-18 who have not received any HPV vaccine.
  • Those who have access to a smartphone or computer with internet connectivity to interact with experiment materials (chatbot or online leaflet).
  • Those who provide informed consent and agree to participate in the study.

Exclusion criteria

  • Those who need help reading through the participant information sheet, providing consent online, accessing experiment materials (chatbot or online leaflet), or answering surveys will be excluded. This may include people who do not have access to an online environment or people with severe cognitive impairments who cannot interact with the experiment materials. Also, those who have participated or are participating in similar studies regarding vaccination or experiments that utilize chatbots will be excluded.

Treatment and study plan

AI-based chatbot

Behavioral

A tailored Japanese HPV vaccination chatbot.

Leaflet

Behavioral

A publicly accessible HPV vaccination leaflet prepared by the Ministry of Health, Labour, and Welfare.

Primary outcomes

  1. health literacy

    Time frame: 2 weeks

    Health literacy related to HPV vaccination will be measured by changes in caregivers' scores on questions concerning facts about HPV vaccines and associated health information. The score consists of 7 factual questions, with total scores ranging from 0 to 7 based on the number of correct responses. Higher scores indicate greater literacy. This metric will be evaluated by determining the proportion of respondents who correctly answer these questions, reflecting their understanding and knowledge.

Secondary outcomes

  1. decision-making

    Time frame: 2 weeks

    Decision-making regarding HPV vaccination will be evaluated based on changes in the uptake status of HPV vaccines among caregivers' daughters. This will be measured by the proportion of respondents who answer 'Yes' to the question, 'Have you decided to vaccinate your daughter against HPV?' Response options will include 'Yes' and 'No.'

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • Nagasaki University

Registry information

Official study title

Enhancing Health Literacy Through Artificial Intelligence-Powered Chatbot: A Randomized Controlled Trial on Addressing Human Papillomavirus Vaccination Misinformation Among Caregivers in Japan

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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