Testimonials and Navigation in Rheumatology

Not Applicable

Recruiting

• Conditions: Autoimmune Diseases; Rheumatologic Disease

• Registration Number: NCT06469788
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-24
• Status Verified: 2024-12
• Study Start: 2024-12-18
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2027-04-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1170

Inclusion Criteria

• 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)

Exclusion Criteria

-Lack of access to phone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Receipt of updated COVID-19 vaccination.	3 months	We will measure rates of receipt of updated COVID-19 vaccination.

Trial Locations

Locations (3)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Brigham Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Massachusetts Chan Medical School; 🇺🇸 Worcester, Massachusetts, United States