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临床试验/NCT06469788
NCT06469788招募中不适用

Improving COVID-19 Vaccine Uptake Among Racial and Ethnic Minority Groups With Rheumatic Diseases

University of Alabama at Birmingham6 个研究点 分布在 1 个国家目标入组 1,170 人开始时间: 2024年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,170
试验地点
6
主要终点
Receipt of updated COVID-19 vaccination.

研究概览

简要总结

The overall goal of this study is to determine whether a novel, multi-modal, patient-directed behavioral intervention initiated in rheumatology clinics is an effective approach to improve uptake of updated COVID-19 vaccine.

详细描述

Black and Latinx persons are at higher risk for certain autoimmune and inflammatory rheumatic diseases (AIRD) and have experienced worse COVID-19 outcomes compared to their white counterparts. Given the risks of severe COVID-19 outcomes such as hospitalization and death in people with AIRD, COVID-19 vaccine is recommended in this population. Historically, overall vaccine uptake among people with AIRDs has been low, and this vaccine reluctance has extended to COVID-19 vaccination. While additional COVID-19 vaccine doses have offered considerable added protection against severe outcomes, only 20% of all vaccinated persons in Alabama (AL) and 45% in Massachusetts have obtained an additional dose of COVID-19 vaccine as of October 2022. Racial and ethnic minority groups have faced disparities in obtaining subsequent COVID-19 vaccines, particularly in under-resourced communities, including those in Alabama and Massachusetts. Together, these obstacles exacerbate existing health inequities among people of color and perpetuate worse COVID-19 outcomes.

We will conduct a randomized controlled study to test an intervention that seeks to address gaps in COVID-19 vaccine information and access inequities common in Black and Latinx populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Care Provider, Investigator)

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

  • Adults (18+ years) with known AIRD
  • Black race and/or Latinx ethnicity
  • Individuals who have not obtained the updated COVID-19 vaccine series (self-report)

排除标准

  • Lack of access to phone

研究组 & 干预措施

"Storytelling" video including patient narratives, brochure and patient navigation

Experimental

Participants will review video with narratives on COVID-19 vaccination in patients with AIRD, receive brochure on the same topic; and interact with patient navigators.

干预措施: Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences (Behavioral)

"Storytelling" video including patient narratives, brochure and patient navigation

Experimental

Participants will review video with narratives on COVID-19 vaccination in patients with AIRD, receive brochure on the same topic; and interact with patient navigators.

干预措施: Brochure on COVID-19 vaccination in AIRD patients (Behavioral)

"Storytelling" video including patient narratives, brochure and patient navigation

Experimental

Participants will review video with narratives on COVID-19 vaccination in patients with AIRD, receive brochure on the same topic; and interact with patient navigators.

干预措施: Patient Navigation (Behavioral)

Attention Control: "Oral Health" video and "Oral Health" brochure

Active Comparator

Participants will review video on the importance of oral health in patients with AIRD and receive brochure on the same topic.

干预措施: Video on the importance of good oral health for patients with AIRD (Behavioral)

Attention Control: "Oral Health" video and "Oral Health" brochure

Active Comparator

Participants will review video on the importance of oral health in patients with AIRD and receive brochure on the same topic.

干预措施: Brochure on the importance of good oral health in AIRD patients (Behavioral)

结局指标

主要结局

Receipt of updated COVID-19 vaccination.

时间窗: 3 months

We will measure rates of receipt of updated COVID-19 vaccination.

次要结局

未报告次要终点

研究者

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

Maria Danila, MD, MSc, MSPH

Professor of Medicine

University of Alabama at Birmingham

研究点 (6)

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