Skip to content

Enhancing Health Literacy Through AI-Powered Chatbot: a Randomized Controlled Trial

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06702423
Enrollment
844
Registered
2024-11-25
Start date
2024-11-25
Completion date
2025-12-31
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

HPV vaccine, AI, chatbot, Randomized Controlled Trial

Brief summary

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.

Detailed description

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: 1. 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. 2. 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.

Interventions

BEHAVIORALAI-based chatbot

A tailored Japanese HPV vaccination chatbot.

BEHAVIORALLeaflet

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

Sponsors

London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Nagasaki University
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
health literacy2 weeksHealth literacy related to HPV vaccination will be measured by changes in caregivers' scores on questions concerning facts about HPV vaccines and associated health information. This metric will be evaluated by determining the proportion of respondents who correctly answer these questions, reflecting their understanding and knowledge.

Secondary

MeasureTime frameDescription
decision-making2 weeksDecision-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.'

Countries

United Kingdom

Contacts

Primary ContactLeesa Lin, PhD
Leesa.Lin@lshtm.ac.uk+44 (0)20 7636 8636
Backup ContactKana Kobayashi, MSPH
Kana.Kobayashi@lshtm.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026