Let's K-Talk - HPV Study for Ethnic Koreans

Let's K-Talk: A Storytelling Intervention Leveraging Chatbot Technology to Prevent HPV and HPV Associated Cancers for Ethnic Koreans Living in the U.S.

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 26.

The main questions this study aims to answer are:

• Is the K-Talk intervention feasible for use among Korean Americans aged 18 to 26?
• 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 26 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.

Study Overview

• Status: Recruiting
• Conditions: Papillomavirus Vaccines; Human Papillomavirus Viruses
• Intervention / Treatment: Other: K-Talk Intervention (Storytelling and K-Bot); Other: Written Information; Other: Storytelling Intervention; Other: K-Bot Intervention

Detailed Description

The objective of this study is to conduct a pilot Multiphase Optimization Strategy trial (MOST) to evaluate the acceptability, feasibility, and preliminary efficacy of K-Talk as an intervention to improve HPV vaccination initiation and completion among Korean American men and women. K-Talk is a user-centered intervention that combines AI chatbot technology with storytelling to enhance health communication, foster connection, and provide accurate advice related to HPV vaccination. The study design follows an optimization phase of the MOST, utilizing a 2 x 2 factorial design with two factors (storytelling and chatbot) and two levels (Yes/On and No/Off). The study aims to recruit a total of 160 participants, with 40 participants assigned to each experimental condition. The sample will consist of 80 males and 80 females who are eligible for participation in factorial experimentation using the MOST design. Interested individuals will undergo an online eligibility screening survey. If eligible for the study, participants will receive an online survey link containing informed consent, a baseline survey, written HPV information, and random assignment to an intervention group.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minjin Kim, PhD., RN; Phone Number: 5135575258; Email: kim3m4@ucmail.uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45221-0038
      • Recruiting
      • Minjin Kim
      • Contact: Minjin Kim; Phone Number: 513-557-5258; Email: kim3m4@ucmail.uc.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Identify as a Korean ethnic person
2. Reside in the U.S.
3. between the ages of 18 and 26
4. be able to speak or read English
5. not have been vaccinated against HPV
6. use a mobile device.

Exclusion Criteria:

1. Participants who do not identify as a Korean ethnic person
2. Participants who do not reside in the U.S.
3. Participants who are not between the ages of 18 and 26.
4. Participants who cannot speak or read English.
5. Participants who have been vaccinated against HPV.
6. Participants who do not use a mobile device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: K-Talk Intervention: Storytelling and AI Chatbot; 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); The K-Talk intervention group receives a combination of a storytelling intervention and an artificial intelligence chatbot (K-Bot) education.; Other: Written Information; The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.
Experimental: Storytelling Intervention; 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: Written Information; The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.; Other: Storytelling Intervention; 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.
Experimental: K-Bot (AI Chatbot Intervention) Intervention; 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: Written Information; The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.; Other: K-Bot Intervention; The K-Bot intervention is a conversational and button-based artificial intelligence Chatbot that is available in both English and Korean.
Active Comparator: Written Information; This group will only be exposed to written, didactic HPV education materials after the pre-test.	Other: Written Information; The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Knowledge about HPV and HPV Vaccines: A 34-Item Survey (True/False/I don't know)	Higher scores represent better knowledge.	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)	Higher scores indicate higher risk perceptions about HPV and STI	at baseline and 3-month follow-up
Assessment of Intention to Receive HPV Vaccine: Two Items Self-Report	Two questions will be used to assess participants' intention to receive HPV vaccines: "Do you intend to get the HPV vaccine?" and "How likely is it that you will get an HPV vaccine in the next 3 months?"	at baseline, 3-month, 6-month, and 12-month follow-up

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Minjin Kim, PhD., RN, UC College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: HPV Vaccines; Korean Americans; Korean immigrants; Storytelling Intervention; Artificial Intelligence Chatbot
• Other Study ID Numbers: HPV Study for Ethnic Koreans

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing only aggregated data will be presented in a summary format without any identifying information about individual participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No