Enhancing Health Literacy Through AI-Powered Chatbot

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Behavioral: AI-based chatbot; Behavioral: Leaflet

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.

• Study Type: Interventional
• Enrollment (Estimated): 844
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leesa Lin, PhD; Phone Number: +44 (0)20 7636 8636; Email: Leesa.Lin@lshtm.ac.uk
• Study Contact Backup: Name: Kana Kobayashi, MSPH; Email: Kana.Kobayashi@lshtm.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • London School of Hygiene and Tropical Medicine
    • Contact: Leesa Lin, PhD; Phone Number: +44 (0)20 7636 8636; Email: Leesa.Lin@lshtm.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-based chatbot; A chatbot that was developed using information related to HPV vaccines from authoritative sources such as the Japanese Ministry of Health, Labour, and Welfare, World Health Organization, Centers for Disease Control and Prevention, and other reputable public health organizations and validated survey questions from published research.	Behavioral: AI-based chatbot; A tailored Japanese HPV vaccination chatbot.
Active Comparator: Leaflet; A leaflet which is a publicly accessible HPV vaccination document prepared by the Ministry of Health, Labour, and Welfare.	Behavioral: Leaflet; A publicly accessible HPV vaccination leaflet prepared by the Ministry of Health, Labour, and Welfare.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the knowledge level regarding HPV vaccines	The participants will be asked the same seven true or false questions concerning facts about HPV vaccines and associated health information before and after they interact with the HPV vaccine chatbot or leaflet. The metric will be evaluated by assessing the percentage of questions each respondent answers correctly before and after exposure to the communication tools, reflecting a degree of a change in their understanding and knowledge of HPV vaccines.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the decision regarding the provision of HPV vaccines for daughters	The participants will be asked whether they have decided to provide their daughters with HPV vaccines after being exposed to the communication tools. The answer options will include: 1) "Yes, my daughter has received a shot," 2) "No, but I got an appointment for my daughter," and 3) "No."	2 weeks

Collaborators and Investigators

• Sponsor: Nagasaki University
• Collaborators: London School of Hygiene and Tropical Medicine; The University of Hong Kong
• Investigators: Principal Investigator: Leesa Lin, PhD, London School of Hygiene and Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 2, 2024
• Primary Completion (Estimated): December 23, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; AI; HPV vaccine; chatbot
• Other Study ID Numbers: UW231392

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No