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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Double (Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
"Storytelling" video including patient narratives, brochure and 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.
  • Behavioral: Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences
    Participants will watch video focused on the importance of receipt of updated COVID-19 vaccination in patients with AIRD
  • Behavioral: Brochure on COVID-19 vaccination in AIRD patients
    Participants
  • Behavioral: Patient Navigation
    Participants will receive phone calls from patient navigators to provide support and information for receipt of updated COVID-19 vaccination in patients with AIRD
Active Comparator
Attention Control: "Oral Health" video and "Oral Health" brochure 		Participants will review video on the importance of oral health in patients with AIRD and receive brochure on the same topic.
  • Behavioral: Video on the importance of good oral health for patients with AIRD
    Participants will watch video on the importance of good oral health in AIRD patients.
    Other names:
    • Attention Control
  • Behavioral: Brochure on the importance of good oral health in AIRD patients
    Participants will receive a brochure on the importance of good oral health in AIRD patients.

Recruiting Locations

More Details

NCT ID
NCT06469788
Status
Not yet recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Stephanie S Ford, Clinical Research Administration Manager, MS
2059347423
sledbetter@uabmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.