NCT05884697

Brief Summary

The goal of this clinical trial is to test the feasibility, acceptability, and preliminary efficacy of a storytelling video-based intervention using AI chatbot technology (K-Talk) to promote HPV vaccination behavior among Korean Americans aged 18 to 45. The main questions this study aims to answer are:

  • Is the K-Talk intervention feasible for use among Korean Americans aged 18 to 45?
  • Is the K-Talk intervention acceptable to the target population?
  • What is the preliminary efficacy of the K-Talk intervention in promoting HPV vaccination uptake? Participants will be Korean Americans aged 18 to 45 who are at risk for HPV infection. Participants will be asked to complete a baseline survey and then will be "randomized" into one of four groups: Group 1 (chatbot + storytelling intervention), Group 2 (chatbot only), Group 3 (storytelling only), and Group 4 will be only exposed to written didactic HPV education materials. All groups will receive written didactic HPV education materials. Researchers will compare how Group 1, a combination of AI Chatbot and storytelling intervention is more effective than other intervention groups in promoting HPV vaccination uptake among underserved, hard-to-reach Korean Americans.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress93%
May 2023Jul 2026

First Submitted

Initial submission to the registry

April 3, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

April 3, 2023

Last Update Submit

August 12, 2025

Conditions

Keywords

Korean immigrantsHPV VaccinesStorytelling InterventionKorean AmericansArtificial Intelligence Chatbot

Outcome Measures

Primary Outcomes (5)

  • Number of participants who completed 3 doses of HPV vaccines at 12-months

    Completion of 3 doses of HPV vaccines

    12 months after the baseline

  • Number of participants who completed 3 doses of HPV vaccines at 6-months

    Completion of 3 doses of HPV vaccines

    6 months after the baseline

  • Number of participants who received at least one dose of HPV vaccine at 3-month

    Participants who received at least one dose of HPV vaccine at 3-month

    3-months after the baseline

  • Number of participants who received at least one dose of HPV vaccine at 6-month

    Participants who received at least one dose of HPV vaccine at 6-month

    6-months after the baseline

  • Number of participants who received at least one dose of HPV vaccine at 12-month

    Participants who received at least one dose of HPV vaccine at 12-month

    12-months after the baseline

Secondary Outcomes (3)

  • Assessment of Knowledge about HPV and HPV Vaccines: A 34-Item Survey (True/False/I don't know)

    at baseline and 3-month follow-up

  • Assessing Perceived Risk of HPV and Other STIs: A 17-Item Survey (on a 1-5 Likert scale)

    at baseline and 3-month follow-up

  • Assessment of Intention to Receive HPV Vaccine: Two Items Self-Report

    at baseline, 3-month, 6-month, and 12-month follow-up

Study Arms (4)

K-Talk Intervention: Storytelling and AI Chatbot

EXPERIMENTAL

After completing the pre-test survey, participants from all intervention groups will receive the written information. Subsequently, they will be randomly assigned to one of the intervention groups. The K-Talk group will receive a series of weekly storytelling videos, and access to the chatbot via the web-based platform KakaoTalk for 3 months.

Other: K-Talk Intervention (Storytelling and K-Bot)Other: Written Information

Storytelling Intervention

EXPERIMENTAL

After completing the pre-test survey, participants from all intervention groups will receive the written information. Subsequently, they will be randomly assigned to one of the intervention groups. The storytelling intervention group will only be exposed to periodic release of stories via email for 3 months.

Other: Storytelling InterventionOther: Written Information

K-Bot (AI Chatbot Intervention) Intervention

EXPERIMENTAL

After completing the pre-test survey, participants from all intervention groups will receive the written information. Subsequently, they will be randomly assigned to one of the intervention groups. The K-Bot group will only interact with the chatbot via the web-based platform or KakaoTalk for 3 months.

Other: K-Bot InterventionOther: Written Information

Written Information

ACTIVE COMPARATOR

This group will only be exposed to written, didactic HPV education materials after the pre-test.

Other: Written Information

Interventions

The K-Talk intervention group receives a combination of a storytelling intervention and an artificial intelligence chatbot (K-Bot) education.

K-Talk Intervention: Storytelling and AI Chatbot

The storytelling intervention features 12 authentic stories from young Korean immigrants and Americans. Each video is about 3 minutes long and includes stories from 1st, 1.5, and 2nd generation young Korean individuals, highlighting their perceptions of HPV and HPV vaccines, and their experiences with HPV vaccination.

Storytelling Intervention

The K-Bot intervention is a conversational and button-based artificial intelligence Chatbot that is available in both English and Korean.

K-Bot (AI Chatbot Intervention) Intervention

The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.

K-Bot (AI Chatbot Intervention) InterventionK-Talk Intervention: Storytelling and AI ChatbotStorytelling InterventionWritten Information

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Identify as a Korean ethnic person
  • Reside in the U.S.
  • between the ages of 18 and 45
  • be able to speak or read English
  • not have been vaccinated against HPV
  • use a mobile device.

You may not qualify if:

  • Participants who do not identify as a Korean ethnic person
  • Participants who do not reside in the U.S.
  • Participants who are not between the ages of 18 and 45.
  • Participants who cannot speak or read English.
  • Participants who have been vaccinated against HPV.
  • Participants who do not use a mobile device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minjin Kim

Cincinnati, Ohio, 45221-0038, United States

Location

Study Officials

  • Minjin Kim, PhD., RN

    UC College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Qualtrics is an online survey software used by researchers. It can randomly assign participants to different groups without revealing the assignments to participants or researchers, blinding them to the assignment. This ensures unbiased treatment and assessment of participants.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Participants will be randomized to one of four experimental conditions using a 2x2 factorial design with two factors (Storytelling and Chatbot) and two levels (Yes/On and No/Off). Acceptability and feasibility outcomes include recruitment/retention rates, obtaining photographic documentation, and perceived satisfaction with the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 3, 2023

First Posted

June 1, 2023

Study Start

May 10, 2023

Primary Completion

March 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Sharing only aggregated data will be presented in a summary format without any identifying information about individual participants.

Locations