NCT06702423

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
844

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 25, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

20 days

First QC Date

November 20, 2024

Last Update Submit

November 20, 2024

Conditions

Healthy

Keywords

HPV vaccineAIchatbotRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • health literacy

    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. This metric will be evaluated by determining the proportion of respondents who correctly answer these questions, reflecting their understanding and knowledge.

    2 weeks

Secondary Outcomes (1)

  • decision-making

    2 weeks

Study Arms (2)

AI-based chatbot

EXPERIMENTAL

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

Leaflet

ACTIVE COMPARATOR

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

Behavioral: Leaflet

Interventions

AI-based chatbotBEHAVIORAL

A tailored Japanese HPV vaccination chatbot.

AI-based chatbot
LeafletBEHAVIORAL

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

Leaflet

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London School of Hygiene and Tropical Medicine

London, United Kingdom

Location

Study Officials

  • Leesa Lin, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leesa Lin, PhD

CONTACT

+44 (0)20 7636 8636Leesa.Lin@lshtm.ac.uk

Kana Kobayashi, MSPH

CONTACT

Kana.Kobayashi@lshtm.ac.uk

Study Design

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

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 25, 2024

Study Start

November 25, 2024

Primary Completion

December 15, 2024

Study Completion

December 31, 2025

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

GB(1)