Testimonials and Navigation in Rheumatology

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06469788
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Alabama at Birmingham
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Maria I Danila, MD, MSc, MSPH
Principal Investigator Affiliation	University of Alabama at Birmingham
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatologic Disease, Autoimmune Diseases

Additional Details

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.

Arms & Interventions

Arms

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.

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Phillip J Foster, MPH

[email protected]

2059966086

Brigham Women's Hospital, Boston, Massachusetts

Status