跳至主要内容
临床试验/NCT05841810
NCT05841810进行中(未招募)不适用

Scaling and Sustaining COVID-19 Vaccination Through Meaningful Community Engagement and Care Coordination for Underserved Communities

University of California, San Diego8 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2024年8月20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
398
试验地点
8
主要终点
COVID-19 vaccination rate

研究概览

简要总结

This study will optimize, implement, and test the impact of our multicomponent health program that includes three primary implementation strategies (Cultural Weavers and co-creation, mHealth strategies using culturally meaningful text and voice messages, and care coordination). The investigators will use a participatory approach to engage community members in co-creating and optimizing our mHealth outreach and enhanced care coordination program components. The investigators will use a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (SMART) design to assess the impact of our multicomponent health program on implementation and outcome measures.

详细描述

This is an adaptive intervention which utilizes a multi-component messaging and care coordination to increase COVID19 vaccine uptake.

Aim 1: Optimize a multicomponent health program to promote COVID-19 vaccine uptake and engagement in preventive healthcare using our established co-creation approach to address multi-level (individual, community, systemic) barriers to vaccine uptake and preventive care engagement.

Community engagement through Community Advisory Boards and Community Weavers. The multicomponent health program will be developed and optimized using our established co-creation approach with guidance from Community Weavers and engagement of the community through Community Advisory Boards (CABs). Hiring criteria for Community Weavers will include that they are fluent in at least one of the three priority languages (i.e., Spanish, Arabic, Vietnamese) and have at least six months of community organizing, leading, or community engagement experience. Community Weavers will have a critical role in developing and refining the tailored mHealth messages. They will also be instrumental in facilitating the existing care coordination efforts at the FQHC by focusing on immigrant and refugee communities that can be difficult to engage in care. The Community Weavers will also lead three CABs that each include five members inclusive of the three primary languages spoken by community members of our clinics of interest will be invited to participate.

During the first year, each CAB will meet monthly or twice monthly up to four times (two hours per meeting). These initial CAB meetings will be charged with co-creating content and frequency for the mHealth outreach (SMS and voice messages) and identifying topics to be covered in and strategies and processes for the care coordination program. To facilitate mHealth message development, Cultural Weavers will use a story telling/narrative framework approach inviting residents to join open dialogue and share their journey through the decision-making process towards getting vaccinated, reflecting on the anxieties they navigated, the misinformation they were confronted with, and any structural or technological barriers they had to overcome to enhance the cultural resonance and tailoring of the mHealth messages.90 In subsequent years, the CABs will continue meeting quarterly to revise and update mHealth content and engage in an Appreciative Inquiry Process to evaluate the implementation of the multicomponent health program and determine when refinements for optimization are needed to both the mHealth and care coordination components. The co-creation and optimization of the program components will be guided by the contextual domains of PRISM (i.e., Intervention characteristics, Recipient characteristics, Implementation and sustainability infrastructure, External environment) and will build on our prior work with the community and the CAB members' lived experience as members of the respective communities.

Throughout the project, the investigators will evaluate the quality and extent of stakeholder engagement using a concurrent (QUAN + QUAL) mixed methods approach that the investigators developed through our NIH funded COVID-19 projects. The investigators will implement a stakeholder engagement survey completed via online distribution by all stakeholders following each CAB meeting using the Goodman et al. 9-item measure inquiring about how well and how frequently eight engagement principles were perceived during the meeting and an open-ended reflection question. Ethnographic documentations of the CAB process will be conducted by trained research staff and will use our structured documentation form that identifies various aspects of engagement (e.g., topics covered, interruptions, time spent contributing). Survey data will be summarized as simple frequencies and text responses will be coded using an open coding approach. Data from the documentation rubrics will be abstracted using a matrix approach the investigators developed in our prior work and will be triangulated with information from the survey. Survey information will be reviewed after each CAB meeting and used to support the iterative improvement of the CAB processes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
Single (Participant)

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

  • Age 18 years or older.
  • Speaks Spanish, Arabic and/or Vietnamese.
  • Current San Ysidro Health patient and receives care at select clinics in study locations (Escondido, El Cajon, Community Heights).

排除标准

  • Not able to provide informed consent.
  • < 18 years old
  • Does not speak Spanish, Arabic or Vietnamese
  • Is not a current San Ysidro Health patient or is a current San Ysidro Health patient but does not receive care at select clinics in study locations (Escondido, El Cajon, Community Heights).

结局指标

主要结局

COVID-19 vaccination rate

时间窗: 36 months after 2nd stage randomization

Clinical assessment of COVID-19 vaccine status based on the total number of COVID-19 vaccines received (initial + boosters).

次要结局

  • Preventive services engagement rate(36 months after 2nd stage randomization)

研究者

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

Nicole Stadnick

Assistant Professor

University of California, San Diego

研究点 (8)

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