Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1170 participants
INTERVENTIONAL
2024-12-18
2027-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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"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.
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
Brochure on COVID-19 vaccination in AIRD patients
Participants
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
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.
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.
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.
Interventions
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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
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.
Brochure on COVID-19 vaccination in AIRD patients
Participants
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Black race and/or Latinx ethnicity
* Individuals who have not obtained the updated COVID-19 vaccine series (self-report)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Maria Danila, MD, MSc, MSPH
Professor of Medicine
Principal Investigators
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Maria I Danila, MD, MSc, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Brigham Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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. doi: 10.1002/art.41450. Epub 2020 Oct 28.
Gianfrancesco MA, Leykina LA, Izadi Z, Taylor T, Sparks JA, Harrison C, Trupin L, Rush S, Schmajuk G, Katz P, Jacobsohn L, Hsu TY, D'Silva KM, Serling-Boyd N, Wallwork R, Todd DJ, Bhana S, Costello W, Grainger R, Hausmann JS, Liew JW, Sirotich E, Sufka P, Wallace ZS, Machado PM, Robinson PC, Yazdany J; COVID-19 Global Rheumatology Alliance. Association of Race and Ethnicity With COVID-19 Outcomes in Rheumatic Disease: Data From the COVID-19 Global Rheumatology Alliance Physician Registry. Arthritis Rheumatol. 2021 Mar;73(3):374-380. doi: 10.1002/art.41567. Epub 2021 Feb 2.
Taylor T, Yazdany J, Gianfrancesco MA. The racial/ethnic and sociocultural aspects of the pandemic in rheumatology. Best Pract Res Clin Rheumatol. 2021 Mar;35(1):101665. doi: 10.1016/j.berh.2021.101665. Epub 2021 Feb 18.
Raiker R, DeYoung C, Pakhchanian H, Ahmed S, Kavadichanda C, Gupta L, Kardes S. Outcomes of COVID-19 in patients with rheumatoid arthritis: A multicenter research network study in the United States. Semin Arthritis Rheum. 2021 Oct;51(5):1057-1066. doi: 10.1016/j.semarthrit.2021.08.010. Epub 2021 Aug 20.
Pablos JL, Galindo M, Carmona L, Lledo A, Retuerto M, Blanco R, Gonzalez-Gay MA, Martinez-Lopez D, Castrejon I, Alvaro-Gracia JM, Fernandez Fernandez D, Mera-Varela A, Manrique-Arija S, Mena Vazquez N, Fernandez-Nebro A; RIER Investigators Group; RIER investigators group. Clinical outcomes of hospitalised patients with COVID-19 and chronic inflammatory and autoimmune rheumatic diseases: a multicentric matched cohort study. Ann Rheum Dis. 2020 Dec;79(12):1544-1549. doi: 10.1136/annrheumdis-2020-218296. Epub 2020 Aug 12.
England BR, Roul P, Yang Y, Kalil AC, Michaud K, Thiele GM, Sauer BC, Baker JF, Mikuls TR. Risk of COVID-19 in Rheumatoid Arthritis: A National Veterans Affairs Matched Cohort Study in At-Risk Individuals. Arthritis Rheumatol. 2021 Dec;73(12):2179-2188. doi: 10.1002/art.41800. Epub 2021 Oct 19.
Other Identifiers
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IRB-300012168
Identifier Type: -
Identifier Source: org_study_id
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