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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Human Papillomavirus Viruses, Papillomavirus Vaccines

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identify as a Korean ethnic person Reside in the U.S. between the ages of 18 and 26 be able to speak or read English not have been vaccinated against HPV use a mobile device. Exclusion Criteria: 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 26. Participants who cannot speak or read English. Participants who have been vaccinated against HPV. Participants who do not use a mobile device.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Korean immigrants, HPV Vaccines, Storytelling Intervention, Korean Americans, Artificial Intelligence Chatbot