Clinical trial NCT05884697: Let's K-Talk - HPV Study for Ethnic Koreans
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papillomavirus Viruses
Papillomavirus Vaccines
Keywords: Korean immigrants
HPV Vaccines
Storytelling Intervention
Korean Americans
Artificial Intelligence Chatbot
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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

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.

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.

Primary outcomes:
measure: Number of participants who completed 3 doses of HPV vaccines at 12-months
timeFrame: 12 months after the baseline
measure: Number of participants who completed 3 doses of HPV vaccines at 6-months
timeFrame: 6 months after the baseline
measure: Number of participants who received at least one dose of HPV vaccine at 3-month
timeFrame: 3-months after the baseline
measure: Number of participants who received at least one dose of HPV vaccine at 6-month
timeFrame: 6-months after the baseline
measure: Number of participants who received at least one dose of HPV vaccine at 12-month
timeFrame: 12-months after the baseline
Secondary outcomes:
measure: Assessment of Knowledge about HPV and HPV Vaccines: A 34-Item Survey (True/False/I don't know)
timeFrame: at baseline and 3-month follow-up
measure: Assessing Perceived Risk of HPV and Other STIs: A 17-Item Survey (on a 1-5 Likert scale)
timeFrame: at baseline and 3-month follow-up
measure: Assessment of Intention to Receive HPV Vaccine: Two Items Self-Report
timeFrame: at baseline, 3-month, 6-month, and 12-month follow-up
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Minjin Kim
state: Ohio
Study officials:
affiliation: UC College of Nursing
name: Minjin Kim, PhD., RN
role: PRINCIPAL_INVESTIGATOR
References: