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临床试验/NCT05884697
NCT05884697进行中(未招募)不适用

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.

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
2
主要终点
Number of participants who received at least one dose of HPV vaccine at 3-month

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • Participants who cannot speak or read English.
  • Participants who have been vaccinated against HPV.
  • Participants who do not use a mobile device.

结局指标

主要结局

Number of participants who received at least one dose of HPV vaccine at 3-month

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 12-months after the baseline

Participants who received at least one dose of HPV vaccine at 12-month

次要结局

  • 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)
  • 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)
  • Assessment of Intention to Receive HPV Vaccine: Two Items Self-Report(at baseline, 3-month, 6-month, and 12-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Minjin Kim

Assistant Professor

University of Cincinnati

研究点 (2)

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Let's K-Talk - HPV Study for Ethnic Koreans | 临床试验