Human Papillomavirus VirusesNCT05884697
Let's K-Talk - HPV Study for Ethnic Koreans
A study testing K-Talk Intervention (Storytelling and K-Bot), Storytelling Intervention and K-Bot Intervention in people with Human Papillomavirus Viruses and Papillomavirus Vaccines, run by University of Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Viruses, Papillomavirus Vaccines
- What is being tested?
- K-Talk Intervention (Storytelling and K-Bot), Storytelling Intervention and K-Bot Intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Identify as a Korean ethnic person
- Reside in the U.S.
- between the ages of 18 and 45
- be able to speak or read English
- not have been vaccinated against HPV
- use a mobile device.
Who cannot join
- 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 45.
- Participants who cannot speak or read English.
- Participants who have been vaccinated against HPV.
- Participants who do not use a mobile device.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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:
Read more
- 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.
Read the 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.
- Being tested
- K-Talk Intervention (Storytelling and K-Bot), Storytelling Intervention, K-Bot Intervention, Written Information
- Keywords
- Korean immigrants, HPV Vaccines, Storytelling Intervention, Korean Americans, Artificial Intelligence Chatbot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-Talk Intervention (Storytelling and K-Bot)Other
The K-Talk intervention group receives a combination of a storytelling intervention and an artificial intelligence chatbot (K-Bot) education.
Storytelling InterventionOther
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 InterventionOther
The K-Bot intervention is a conversational and button-based artificial intelligence Chatbot that is available in both English and Korean.
Written InformationOther
The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.
| Study group | Role | What they receive |
|---|---|---|
| K-Talk Intervention: Storytelling and AI Chatbot | Experimental | 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. Receives: Other: K-Talk Intervention (Storytelling and K-Bot); Other: Written Information |
| Storytelling Intervention | Experimental | 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. Receives: Other: Storytelling Intervention; Other: Written Information |
| K-Bot (AI Chatbot Intervention) Intervention | Experimental | 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. Receives: Other: K-Bot Intervention; Other: Written Information |
| Written Information | Active comparator | This group will only be exposed to written, didactic HPV education materials after the pre-test. Receives: Other: Written Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who completed 3 doses of HPV vaccines at 12-months
Completion of 3 doses of HPV vaccines
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12-months after the baseline
Secondary outcomes (3)
Assessment of Knowledge about HPV and HPV Vaccines: A 34-Item Survey (True/False/I don't know)
Higher scores represent better knowledge.
Measured: 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
Measured: 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?"
Measured: at baseline, 3-month, 6-month, and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start10 May 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VirusesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjin Kim, University of Cincinnati
- Investigators
- Minjin Kim, PhD., RN, Principal investigator, UC College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884697
- Sponsor's protocol ID
- HPV Study for Ethnic Koreans
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing only aggregated data will be presented in a summary format without any identifying information about individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05884697
- Acronym / sponsor ID
- HPV Study for Ethnic Koreans
- Keywords
- Korean immigrants, HPV Vaccines, Storytelling Intervention, Korean Americans, Artificial Intelligence Chatbot
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| K-Talk Intervention: Storytelling and AI Chatbot | Experimental | Other: K-Talk Intervention (Storytelling and K-Bot), Other: Written InformationAfter 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. |
| Storytelling Intervention | Experimental | Other: Storytelling Intervention, Other: Written InformationAfter 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-Bot (AI Chatbot Intervention) Intervention | Experimental | Other: K-Bot Intervention, Other: Written InformationAfter 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. |
| Written Information | Active comparator | Other: Written InformationThis group will only be exposed to written, didactic HPV education materials after the pre-test. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Identify as a Korean ethnic person
- Reside in the U.S.
- between the ages of 18 and 45
- be able to speak or read English
- not have been vaccinated against HPV
Key exclusion criteria (6 listed)
- 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 45.
- Participants who cannot speak or read English.
- Participants who have been vaccinated against HPV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | K-Talk Intervention: Storytelling and AI Chatbot |
| Storytelling InterventionThe 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. | Other | Storytelling Intervention |
| K-Bot InterventionThe K-Bot intervention is a conversational and button-based artificial intelligence Chatbot that is available in both English and Korean. | Other | K-Bot (AI Chatbot Intervention) Intervention |
| Written InformationThe written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines. | Other | K-Bot (AI Chatbot Intervention) Intervention, K-Talk Intervention: Storytelling and AI Chatbot, Storytelling Intervention, Written Information |
Primary outcome
Number of participants who completed 3 doses of HPV vaccines at 12-months
Time frame: 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
Time frame: 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 3-month
Time frame: 3-months after the baseline
Participants who received at least one dose of HPV vaccine at 3-month
Number of participants who received at least one dose of HPV vaccine at 6-month
Time frame: 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
Time frame: 12-months after the baseline
Participants who received at least one dose of HPV vaccine at 12-month
3 secondary outcomes
Assessment of Knowledge about HPV and HPV Vaccines: A 34-Item Survey (True/False/I don't know)
Time frame: 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)
Time frame: at baseline and 3-month follow-up
Assessment of Intention to Receive HPV Vaccine: Two Items Self-Report
Time frame: at baseline, 3-month, 6-month, and 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No. Sharing only aggregated data will be presented in a summary format without any identifying information about individual participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minjin Kim, PhD., RN principal investigator
UC College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K-Talk Intervention (Storytelling and K-Bot), Storytelling Intervention and K-Bot Intervention in people with Human Papillomavirus Viruses and Papillomavirus Vaccines, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who completed 3 doses of HPV vaccines at 12-months (time frame: 12 months after the baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.