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

Not Applicable

Recruiting

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

• Registration Number: NCT05884697
• Lead Sponsor: University of Cincinnati

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.

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 Timeline

• Study First Submitted: 2023-04-03
• Study Start: 2023-05-10
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Storytelling Intervention	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.
K-Talk Intervention: Storytelling and AI Chatbot	Written Information	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.
Written Information	Written Information	This group will only be exposed to written, didactic HPV education materials after the pre-test.
K-Talk Intervention: Storytelling and AI Chatbot	K-Talk Intervention (Storytelling and K-Bot)	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.
K-Bot (AI Chatbot Intervention) Intervention	Written Information	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.
K-Bot (AI Chatbot Intervention) Intervention	K-Bot 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.
Storytelling Intervention	Written Information	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who received at least one dose of HPV vaccine at 3-month	3-months after the baseline	Participants who received at least one dose of HPV vaccine at 3-month
Number of participants who completed 3 doses of HPV vaccines at 12-months	12 months after the baseline	Completion of 3 doses of HPV vaccines
Number of participants who completed 3 doses of HPV vaccines at 6-months	6 months after the baseline	Completion of 3 doses of HPV vaccines
Number of participants who received at least one dose of HPV vaccine at 6-month	6-months after the baseline	Participants who received at least one dose of HPV vaccine at 6-month
Number of participants who received at least one dose of HPV vaccine at 12-month	12-months after the baseline	Participants who received at least one dose of HPV vaccine at 12-month

Secondary Outcome Measures

Name	Time	Method
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	Higher scores represent better knowledge.
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	Higher scores indicate higher risk perceptions about HPV and STI
Assessment of Intention to Receive HPV Vaccine: Two Items Self-Report	at baseline, 3-month, 6-month, and 12-month follow-up	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?"

Trial Locations

Locations (1)

Minjin Kim; 🇺🇸 Cincinnati, Ohio, United States