Testimonials and Navigation in Rheumatology

Not Applicable

Recruiting

• Conditions: Autoimmune Diseases; Rheumatologic Disease
• Interventions: Behavioral: Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences; Behavioral: Video on the importance of good oral health for patients with AIRD; Behavioral: Brochure on the importance of good oral health in AIRD patients; Behavioral: Brochure on COVID-19 vaccination in AIRD patients; Behavioral: Patient Navigation

• 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

Arm && Interventions

Group	Intervention	Description
Attention Control: "Oral Health" video and "Oral Health" brochure	Brochure on the importance of good oral health in AIRD patients	Participants will review video on the importance of oral health in patients with AIRD and receive brochure on the same topic.
"Storytelling" video including patient narratives, brochure and patient navigation	Patient Navigation	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.
"Storytelling" video including patient narratives, brochure and patient navigation	Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences	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.
"Storytelling" video including patient narratives, brochure and patient navigation	Brochure on COVID-19 vaccination in AIRD patients	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.
Attention Control: "Oral Health" video and "Oral Health" brochure	Video on the importance of good oral health for patients with AIRD	Participants will review video on the importance of oral health in patients with AIRD and receive brochure on the same topic.

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