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

Trial Title: Let's K-Talk - HPV Study for Ethnic Koreans

NCT ID: NCT05884697

Condition: Human Papillomavirus Viruses
Papillomavirus Vaccines

Conditions: Keywords:
Korean immigrants
HPV Vaccines
Storytelling Intervention
Korean Americans
Artificial Intelligence Chatbot

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Factorial Assignment

Intervention 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.

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: 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.

Intervention:

Intervention type: Other
Intervention name: K-Talk Intervention (Storytelling and K-Bot)
Description: The K-Talk intervention group receives a combination of a storytelling intervention and an artificial intelligence chatbot (K-Bot) education.
Arm group label: K-Talk Intervention: Storytelling and AI Chatbot

Intervention type: Other
Intervention name: Storytelling Intervention
Description: 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.
Arm group label: Storytelling Intervention

Intervention type: Other
Intervention name: K-Bot Intervention
Description: The K-Bot intervention is a conversational and button-based artificial intelligence Chatbot that is available in both English and Korean.
Arm group label: K-Bot (AI Chatbot Intervention) Intervention

Intervention type: Other
Intervention name: Written Information
Description: The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.
Arm group label: K-Bot (AI Chatbot Intervention) Intervention
Arm group label: K-Talk Intervention: Storytelling and AI Chatbot
Arm group label: Storytelling Intervention
Arm group label: Written Information

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.

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Minjin Kim

Address:
City: Cincinnati
Zip: 45221-0038
Country: United States

Status: Recruiting

Contact:
Last name: Minjin Kim

Phone: 513-557-5258
Email: kim3m4@ucmail.uc.edu

Start date: May 10, 2023

Completion date: July 31, 2025

Lead sponsor:
Agency: University of Cincinnati
Agency class: Other

Source: University of Cincinnati

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05884697