Testimonials and Navigation in Rheumatology (TANGO)

May 1, 2026 updated by: Maria Danila, MD, MSc, MSPH, University of Alabama at Birmingham

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mary A Wilkenson, Clinical Research Coordinator, BS
  • Phone Number: 205-996-7875
  • Email: mawilkenson@uabmc.edu

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Maria Danila, MD MSc MSPH
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Brigham Women's Hospital
        • Contact:
      • Worcester, Massachusetts, United States, 01655
        • Not yet recruiting
        • University of Massachusetts Chan Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of updated COVID-19 vaccination.
Time Frame: 3 months
We will measure rates of receipt of updated COVID-19 vaccination.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Maria I Danila, MD, MSc, MSPH, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300012168
  • 5R01MD019235 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autoimmune Diseases

Clinical Trials on Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe