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

Papillomavirus Vaccines Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884697
• Other study ID #: HPV Study for Ethnic Koreans
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: University of Cincinnati
• Contact: Minjin Kim, PhD., RN
• Phone: 5135575258
• Email: kim3m4[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Identify as a Korean ethnic person

2. Reside in the U.S.

3. between the ages of 18 and 45

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 45.

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.

Related Conditions & MeSH terms

• Human Papillomavirus Viruses
• Papillomavirus Vaccines

Intervention

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.
• 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.
• K-Bot Intervention
The K-Bot intervention is a conversational and button-based artificial intelligence Chatbot that is available in both English and Korean.
• Written Information
The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.

Locations

Country	Name	City	State
United States	Minjin Kim	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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