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临床试验/NCT06290206
NCT06290206已完成不适用

PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - BootCamp Translation

University of Utah2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Number of Parents Participating in BCT

研究概览

简要总结

This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, this intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States.

The proposed study will determine the components of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. This study is a boot camp translation to tailor messaging based on patient and provider input.

This study will refine intervention components and messages to increase HPV vaccination among rural children and adolescents (C/A). The research team will use a validated patient-engaged approach for parents/caregivers (P/Cs), Bootcamp Translation (BCT), with separate sessions conducted in English and Spanish.

详细描述

The PREVENT BootCamp Translation (BCT) study will determine the components and messages of reminders to encourage parents to obtain an HPV vaccine for their age-eligible children and adolescents (C/A)

This study will design format and content of an intervention to promote adolescent HPV vaccine coverage that will consider unique information needs of diverse rural parents/caregivers. The study team will use BCT to develop locally relevant intervention materials (e.g., reminder phone scripts for automated calls, text messages, and patient portal messages for P/C). Targeted promotional materials for HPV vaccination are available in Spanish and could be translated into other languages, as needed. Newly designed messages and materials will seek to counter anti-vaccination sentiment by leveraging cancer prevention, vaccine effectiveness, and vaccine safety messages. BCT methods will provide the framework to tailor HPV vaccination messages for rural and Hispanic IMW P/C.

Bootcamp Translation (BCT), a method for engaging diverse stakeholders in a consensus-building process, has been used by this research team to actively develop and adapt study interventions. It uses an iterative, flexible schedule of face-to-face meetings combined with short, focused teleconferences in a process that addresses 2 questions: "What do we need to say in our message to the community (newly HPV vaccine-eligible adolescents and adolescents who have not completed the HPV vaccination series)?" and "How do we deliver that message to our community?" BCT emphasizes no wrong answers and no hierarchy of expertise. The process requires up to nine (9) hours of participant time over 3-6 months. Participants will be surveyed before and after the in-person session to assess learning outcomes and capture basic sociodemographic information.

With Sea Mar's project manager and/or Sea Mar's designated team member(s), this study will recruit P/C (i.e., participants) for BCT sessions by generating a list of potential P/C of patients across 4 clinics. This study will recruit 6 participants from each clinic (24 total): 12 whose preferred language is English and 12 whose preferred language is Spanish. About two Sea Mar staff members will participate in BCT.

Two parallel sessions will be conducted, one in English and one in Spanish, with approximately 12 study participants per session. The in-person or live Zoom presentation will consist of an expert presentation, and/or subject matter experts. They will share research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. They will educate participants about the six different types of cancers that are prevented by the HPV vaccine among women and men in the United States. The study Investigators and/or subject matter experts to whom they delegate this responsibility will also present up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) as well as novel formats for educational messages (e.g., digital videos, narratives).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None (Participant, Care Provider)

入排标准

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

入选标准

  • Parents/Caregivers (P/C) of children/adolescents (C/A) ages 9-17 years of age (i.e., age-eligible for HPV vaccination);
  • P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 months); and
  • P/C who speak either English or Spanish.

排除标准

  • P/C of C/A with previous excluding HPV vaccination history (e.g., completed vaccination, or not due);
  • P/C of C/A with clinical conditions that influence the CDC HPV vaccination recommendations (e.g., pregnancy);
  • P/C of C/A with other factors that would influence CDC HPV recommendations; and
  • P/C that does not speak Spanish or English.

结局指标

主要结局

Number of Parents Participating in BCT

时间窗: 1 day after study enrollment

This outcome measure will report the number of participants who participant in the BCT English sessions and number of participants who participant in the BCT Spanish sessions. BCT is a community-based research approach to develop and evaluate messaging for health related issues. This study will employ BCT to determine the frequency and content of HPV messaging for future research.

次要结局

  • Likelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This Year(After the in-person session (1 day))
  • Satisfaction With BCT Session(After the in-person session (1 day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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