Testimonials and Navigation in Rheumatology (TANGO)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Rheumatologic Disease; Autoimmune Diseases

Treatments: 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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06469788

IRB-300012168

5R01MD019235 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,170 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Patient Navigation

Behavioral: Brochure on COVID-19 vaccination in AIRD patients

Behavioral: Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences

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

Active Comparator group

Description:

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

Treatment:

Behavioral: Brochure on the importance of good oral health in AIRD patients

Behavioral: Video on the importance of good oral health for patients with AIRD