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Testimonials and Navigation in Rheumatology

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06469788
Acronym
TANGO
Enrollment
1170
Registered
2024-06-24
Start date
2024-12-18
Completion date
2028-05-31
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Rheumatologic Disease

Keywords

COVID-19 vaccination, Rheumatic Diseases

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.

Interventions

BEHAVIORALVideo 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

BEHAVIORALVideo 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.

BEHAVIORALBrochure on COVID-19 vaccination in AIRD patients

Participants

BEHAVIORALPatient 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

BEHAVIORALBrochure 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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Receipt of updated COVID-19 vaccination.3 monthsWe will measure rates of receipt of updated COVID-19 vaccination.

Countries

United States

Contacts

CONTACTMary A Wilkenson, Clinical Research Coordinator, BS
mawilkenson@uabmc.edu205-996-7875
CONTACTPaolo Rusconi, Project Director, PhD
paolorusconi@uabmc.edu
PRINCIPAL_INVESTIGATORMaria I Danila, MD, MSc, MSPH

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026