Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT06469788

Conditions

Rheumatologic Disease

Autoimmune Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Rheumatologic Disease

Autoimmune Diseases

Study ID

NCT06469788

Start date

Dec 18, 2024

Status verified date

May, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mary A Wilkenson, Clinical Research Coordinator, BS

205-996-7875mawilkenson@uabmc.edu

Paolo Rusconi, Project Director, PhD

paolorusconi@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Leslie R Johnson

205764-3373lmroop@uabmc.edu

Principal Investigator:

Maria Danila, MD MSc MSPH

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • COVID-19 vaccination
  • Rheumatic Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-06.