K-Talk Intervention for HPV Vaccination

Overseen By Minjin Kim, PhD., RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Non-Korean, Outside U.S., Age, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on promoting HPV vaccination through educational interventions, so it's unlikely that your current medications will be affected.

Is the K-Talk Intervention for HPV Vaccination safe for humans?

The studies on the K-Talk Intervention, which uses conversational agents and storytelling videos for HPV vaccine counseling, show that participants found these tools easy to use and effective in improving their knowledge and attitudes towards the HPV vaccine. There are no reported safety concerns in the available research. ^{1 2 3 4 5}

How is the K-Talk Intervention treatment for HPV vaccination different from other treatments?

The K-Talk Intervention is unique because it uses storytelling videos and an AI chatbot to educate and encourage people to get the HPV vaccine, making it more engaging and interactive compared to traditional information-based methods. ^{1 3 6 7 8}

What data supports the effectiveness of the K-Talk Intervention for HPV Vaccination?

Research shows that using conversational agents (like chatbots) for HPV vaccine counseling can positively impact beliefs about the vaccine and improve its uptake. Additionally, storytelling video interventions have been found to significantly increase the likelihood of getting the HPV vaccine, especially in specific groups like Korean American college women. ^{1 2 3 4 6}

Who Is on the Research Team?

Minjin Kim, PhD., RN

Principal Investigator

UC College of Nursing

Are You a Good Fit for This Trial?

This trial is for Korean Americans aged 18 to 26 who live in the U.S., speak or read English, have not received an HPV vaccine, and use a mobile device. It's designed to see if a video and chatbot program can increase HPV vaccination rates.

Inclusion Criteria

Identify as a Korean ethnic person

Reside in the U.S.

Be able to speak or read English

Exclusion Criteria

Participants who do not identify as a Korean ethnic person

Participants who do not reside in the U.S.

Participants who cannot speak or read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Online eligibility screening survey

Baseline Assessment

Participants complete a baseline survey and are randomized into intervention groups

1 week

Online survey

Intervention

Participants receive their assigned intervention (chatbot, storytelling, or both) for 3 months

3 months

Weekly interactions via web-based platform or email

Follow-up

Participants are monitored for HPV vaccination uptake and knowledge assessment

12 months

Follow-up surveys at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• K-Bot Intervention
• K-Talk Intervention
• Storytelling Intervention
• Written Information

Trial Overview The study tests K-Talk, which combines storytelling videos and AI chatbot technology to encourage HPV vaccinations. Participants are split into four groups: one with both chatbot and storytelling, one with just the chatbot, one with only storytelling, and one receiving written information.

How Is the Trial Designed?

Group I: Storytelling Intervention Experimental Treatment 2 Interventions

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.

Group II: K-Talk Intervention: Storytelling and AI Chatbot Experimental Treatment 2 Interventions

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.

Group III: K-Bot (AI Chatbot Intervention) Intervention Experimental Treatment 2 Interventions

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.

Group IV: Written Information Active Control 1 Intervention

This group will only be exposed to written, didactic HPV education materials after the pre-test.

K-Talk Intervention is already approved in United States for the following indications:

Approved in United States as K-Talk for:

• Promotion of HPV vaccination behavior among Korean Americans aged 18 to 45

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Published Research Related to This Trial

The study evaluated a conversational agent designed to provide HPV vaccine counseling to young college adults (n=24), showing that participants found it to have high usability, comparable to other voice interactive systems.

There is evidence suggesting that the conversational agent positively influenced participants' beliefs about the HPV vaccine, potentially addressing concerns about its safety and effectiveness, which could help improve vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining Potential Usability and Health Beliefs Among Young Adults Using a Conversational Agent for HPV Vaccine Counseling. Amith, M., Lin, R., Cunningham, R., et al.[2020]

A pilot study involving 104 Korean American college women found that a storytelling video intervention significantly improved knowledge and attitudes towards the HPV vaccine compared to traditional written materials.

At a 2-month follow-up, women who viewed the storytelling video were twice as likely to receive the HPV vaccine, indicating the potential effectiveness of this intervention in promoting vaccination in a population with low screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Storytelling Intervention in a Mobile, Web-Based Platform: A Pilot Randomized Controlled Trial to Evaluate the Preliminary Effectiveness to Promote Human Papillomavirus Vaccination in Korean American College Women. Kim, M., Lee, H., Kiang, P., et al.[2022]

Training providers to use presumptive 'announcements' significantly increased HPV vaccination initiation by 5.4% among adolescents aged 11 or 12 years compared to control clinics, indicating that this approach is effective in improving vaccination rates.

Conversational training did not lead to any significant changes in HPV vaccination coverage, suggesting that the method of recommendation plays a crucial role in influencing parents' decisions to vaccinate their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Brewer, NT., Hall, ME., Malo, TL., et al.[2022]

A systematic review of 12 randomized controlled trials involving 38,945 participants found that communication technology interventions significantly improve the initiation and completion rates of HPV vaccinations compared to control groups.

Various methods such as text messaging, automated phone calls, and electronic health record prompts were effective in increasing vaccination coverage, suggesting that these technologies can play a crucial role in future HPV vaccination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication technologies to improve HPV vaccination initiation and completion: A systematic review. Francis, DB., Cates, JR., Wagner, KPG., et al.[2022]

In a study involving 18 parents, a conversational agent was tested for communicating health information about the HPV vaccine, showing that non-vaccine hesitant parents found it easy to use and effective for conveying information.

The research suggests that using conversational agents may enhance communication about vaccines compared to traditional methods, indicating potential for increased vaccine uptake in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Usability Assessment of a Conversational Agent for HPV Vaccination. Amith, M., Zhu, A., Cunningham, R., et al.[2020]

The study demonstrated that virtual digital storytelling (DST) workshops are a feasible and well-accepted method for engaging Vietnamese American and Korean American mothers in discussions about HPV vaccination, with high satisfaction ratings (mean 4.2-5).

The workshops revealed six major themes related to mothers' experiences and attitudes towards HPV vaccination, highlighting the importance of culturally relevant health communication in improving vaccination rates among these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Culturally and Linguistically Congruent Digital Storytelling Intervention in Vietnamese and Korean American Mothers of Human Papillomavirus-Vaccinated Children: Feasibility and Acceptability Study. Kim, SW., Chen, AC., Ou, L., et al.[2023]

A study involving 22 parents of children aged 11-13 revealed that barriers like misinformation and facilitators such as pediatrician recommendations significantly influence HPV vaccination decisions.

The research identified 11 recommendations for improving HPV vaccination interventions, emphasizing the need for trusted information sources, family-oriented messaging, and an enhanced clinic experience to support parents in making informed decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing Content and Feature Design of a Parent-Focused Human Papillomavirus Vaccination Digital Behavior Change Intervention: Synchronous Text-Based Focus Group Study. Becker, ER., Shegog, R., Savas, LS., et al.[2022]

Only 22% of sexual and reproductive health (SRH) professionals viewed AI-enabled chatbots as effective for providing advice, indicating a significant level of skepticism about their utility in this field.

While chatbots were accepted for tasks like appointment booking and general advice, there was considerable hesitancy regarding their use for sensitive areas such as safeguarding and emotional support, primarily due to concerns about patient safety and unfamiliarity with the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"But can chatbots understand sex?" Attitudes towards artificial intelligence chatbots amongst sexual and reproductive health professionals: An exploratory mixed-methods study. Nadarzynski, T., Lunt, A., Knights, N., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Examining Potential Usability and Health Beliefs Among Young Adults Using a Conversational Agent for HPV Vaccine Counseling. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A Storytelling Intervention in a Mobile, Web-Based Platform: A Pilot Randomized Controlled Trial to Evaluate the Preliminary Effectiveness to Promote Human Papillomavirus Vaccination in Korean American College Women. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Communication technologies to improve HPV vaccination initiation and completion: A systematic review. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Early Usability Assessment of a Conversational Agent for HPV Vaccination. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Developing a Culturally and Linguistically Congruent Digital Storytelling Intervention in Vietnamese and Korean American Mothers of Human Papillomavirus-Vaccinated Children: Feasibility and Acceptability Study. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Informing Content and Feature Design of a Parent-Focused Human Papillomavirus Vaccination Digital Behavior Change Intervention: Synchronous Text-Based Focus Group Study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

"But can chatbots understand sex?" Attitudes towards artificial intelligence chatbots amongst sexual and reproductive health professionals: An exploratory mixed-methods study. [2023]