Lupus Education & Alliance Program (LEAP)

University of Alabama at Birmingham, Ochsner Health System, Louisiana State University Health Sciences Center in New Orleans

The purpose of this study is to evaluate the efficacy of a peer-outreach/education intervention to promote COVID-19 testing/vaccination for people living with systemic lupus erythematosus and members of their social networks.

This study uses a wait-list control study design. Participants are randomized to experimental and wait-list control groups. After 1 month, control group participants will be offered the opportunity to participate in the experimental intervention. An exploratory aim will attempt to enroll members of participants' social networks who will be randomized to experimental and wait-list control groups.

Participants in the experimental and wait-list control groups will not be informed of study arm assignment.

The experimental group will be offered the intervention, involving COVID-19 education, testing and vaccination information, as well as scheduling appointments and arranging transportation for testing/vaccination.

The wait-list control group will only receive brief COVID-19 education and information about clinical guidelines for testing and the benefits of vaccination. Control group participants who have not been tested/vaccinated at 1-month follow-up will be asked about their interest in the experimental intervention.

The vaccine concierge intervention involves COVID-19 education, testing, and vaccination information in the context of living with an autoimmune disease. Participants assigned to the experimental group will also receive information on the availability of COVID-19 testing and vaccination, and if desired, study staff will arrange for testing/vaccination appointments or mailing of at-home testing kits, transportation to appointments (if requested), and follow-up of testing/vaccination status.

We will assess COVID-19 test utilization by sending participants follow-up surveys which ask about the use of at-home tests or testing performed at FDA authorized sites. We will also ask the result of their test (positive, negative, inconclusive, did not test) as a secondary outcome.

We will assess COVID-19 vaccination rates among those not fully vaccinated and boosted by sending participants follow-up surveys which ask if any new vaccination doses have been received or scheduled, including the dose type (e.g., initial dose, booster), brand, and location of vaccination appointment.

Inclusion Criteria: Living with systemic lupus erythematosus (SLE), At least 18 years of age, Ability to speak and understand English, and Living in metropolitan Birmingham, Alabama Exclusion Criteria: No confirmed diagnosis of SLE, Younger than 18 years of age, Inability to speak or understand English, and Living outside of metropolitan Birmingham, Alabama

Upon completion of the study and primary analyses, de-identified data will be made available to researchers outside the study team. Data requests, including a list of variables and analytic plan, will be sent to the Project Coordinator and reviewed by the PI, who will approve or deny the data request.