Testimonials and Navigation in Rheumatology

Official title

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

Overview

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

• 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 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.
• 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
• 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.

Primary outcome measures

• Receipt of updated COVID-19 vaccination. [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

United States · 3 centers

• University of Alabama at Birmingham — Birmingham
• Brigham Women's Hospital — Boston
• University of Massachusetts Chan Medical School — Worcester

Publications

• Feldman CH, Ramsey-Goldman R. Widening Disparities Among Patients With Rheumatic Diseases in the COVID-19 Era: An Urgent Call to Action. Arthritis Rheumatol. 2020 Sep;72(9):1409-1411. doi: 10.1002/art.41306. Epub 2020 Aug 9. No abstract available. PMID 32379381
• Hmamouchi I, Winthrop K, Launay O, Dougados M. Low rate of influenza and pneumococcal vaccine coverage in rheumatoid arthritis: data from the international COMORA cohort. Vaccine. 2015 Mar 17;33(12):1446-52. doi: 10.1016/j.vaccine.2015.01.065. Epub 2015 Feb 7. PMID 25659279
• Costello R, Winthrop KL, Pye SR, Brown B, Dixon WG. Influenza and Pneumococcal Vaccination Uptake in Patients with Rheumatoid Arthritis Treated with Immunosuppressive Therapy in the UK: A Retrospective Cohort Study Using Data from the Clinical Practice Research Datalink. PLoS One. 2016 Apr 20;11(4):e0153848. doi: 10.1371/journal.pone.0153848. eCollection 2016. PMID 27096429
• Boucher VG, Pelaez S, Gemme C, Labbe S, Lavoie KL. Understanding factors associated with vaccine uptake and vaccine hesitancy in patients with rheumatoid arthritis: a scoping literature review. Clin Rheumatol. 2021 Feb;40(2):477-489. doi: 10.1007/s10067-020-05059-7. Epub 2020 Jul 3. PMID 32621081
• Hua C, Morel J, Ardouin E, Ricard E, Foret J, Mathieu S, Combe B, Lukas C. Reasons for non-vaccination in French rheumatoid arthritis and spondyloarthritis patients. Rheumatology (Oxford). 2015 Apr;54(4):748-50. doi: 10.1093/rheumatology/keu531. Epub 2015 Feb 8. No abstract available. PMID 25667433
• Qendro T, de la Torre ML, Panopalis P, Hazel E, Ward BJ, Colmegna I, Hudson M. Suboptimal Immunization Coverage among Canadian Rheumatology Patients in Routine Clinical Care. J Rheumatol. 2020 May 1;47(5):770-778. doi: 10.3899/jrheum.181376. Epub 2019 Jul 15. PMID 31308211
• Curtis JR, Johnson SR, Anthony DD, Arasaratnam RJ, Baden LR, Bass AR, Calabrese C, Gravallese EM, Harpaz R, Kroger A, Sadun RE, Turner AS, Williams EA, Mikuls TR. American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3. Arthritis Rheumatol. 2021 Oct;73(10):e60-e75. doi: 10.1002/art.41928. Epub 2021 Aug 4. PMID 34346564
• Fernandez-Ruiz R, Masson M, Kim MY, Myers B, Haberman RH, Castillo R, Scher JU, Guttmann A, Carlucci PM, Deonaraine KK, Golpanian M, Robins K, Chang M, Belmont HM, Buyon JP, Blazer AD, Saxena A, Izmirly PM; NYU WARCOV Investigators. Leveraging the United States Epicenter to Provide Insights on COVID-19 in Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2020 Dec;72(12):1971-1980. d PMID 32715660

Identifiers

NCT: NCT06469788 · IRB-300012168 · 5R01MD019235

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗