Rheumatologic DiseaseTANGONCT06469788
Testimonials and Navigation in Rheumatology
A study testing Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences, Video on the importance of good oral health for patients with AIRD and Brochure on COVID-19 vaccination in AIRD patients in people with Rheumatologic Disease and Autoimmune Diseases, run by University of Alabama at Birmingham at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatologic Disease, Autoimmune Diseases
- What is being tested?
- Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences, Video on the importance of good oral health for patients with AIRD and Brochure on COVID-19 vaccination in AIRD patients
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,170 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Dec 2024to 31 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- -Lack of access to phone
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Paolo Rusconi, Project Director, PhD contact
United States4 sites, 4 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Leslie R Johnson, 205764-3373, lmroop@uabmc.edu
Maria Danila, MD MSc MSPH
- Recruiting
Brigham Women's Hospital
Boston, Massachusetts, 02115
Candace Feldman, Site Principal Investigator, MD, ScD, cfeldman@bwh.harvard.edu
- Recruiting
Northwestern University
Evanston, Illinois, 60208
Rosalind Ramsey-Goldman, MD, DrPH, 312-503-0542, rgramsey@northwestern.edu
Kathleen Aren, MPH, 312-503-1824, kathleen.aren@northwestern.edu
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Jonathan Kay, Site Principal Investigator, MD, jonathan.kay@umassmemorial.org
About this study
Official title: 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.
Read the 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, Massachusetts, and Illinois. 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.
- Conditions
- Rheumatologic Disease, Autoimmune Diseases
- Being tested
- Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences, Video on the importance of good oral health for patients with AIRD, Brochure on COVID-19 vaccination in AIRD patients, Patient Navigation, Brochure on the importance of good oral health in AIRD patients
- Keywords
- COVID-19 vaccination, Rheumatic Diseases
- Medical subject headings
- Collagen Diseases, Autoimmune Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiencesBehavioural
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 AIRDBehavioural
Also called Attention Control
Participants will watch video on the importance of good oral health in AIRD patients.
Brochure on COVID-19 vaccination in AIRD patientsBehavioural
Participants
Patient NavigationBehavioural
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 patientsBehavioural
Participants will receive a brochure on the importance of good oral health in AIRD patients.
| Study group | Role | What they receive |
|---|---|---|
| "Storytelling" video including patient narratives, brochure and patient navigation | Experimental | 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. Receives: Behavioral: Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences; Behavioral: Brochure on COVID-19 vaccination in AIRD patients; Behavioral: Patient Navigation |
| Attention Control: "Oral Health" video and "Oral Health" brochure | Active comparator | Participants will review video on the importance of oral health in patients with AIRD and receive brochure on the same topic. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of updated COVID-19 vaccination.
We will measure rates of receipt of updated COVID-19 vaccination.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start18 Dec 2024
- Primary completion15 Sep 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Rheumatologic DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 1,170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Maria Danila, MD, MSc, MSPH, University of Alabama at Birmingham
- Investigators
- Maria I Danila, MD, MSc, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469788
- Sponsor's protocol ID
- IRB-300012168
- Other IDs
- 5R01MD019235
- Acronym
- TANGO
- Status last verified
- May 2026
- First submitted
- 14 Jun 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32379381Hmamouchi 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.
PubMed 25659279Costello 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.
PubMed 27096429Boucher 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.
PubMed 32621081Hua 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.
PubMed 25667433Qendro 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.
PubMed 31308211Curtis 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.
PubMed 34346564Fernandez-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.
PubMed 32715660Gianfrancesco 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.
PubMed 33146001Taylor 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.
PubMed 33648855Raiker 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.
PubMed 34450504Pablos 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.
PubMed 32796045England 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.
PubMed 33955209