Alabama Lupus Education & Alliance Program

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
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:

  • - 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

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.

NCT05243875
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.

Tulane University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David H Chae, Sc.D., M.A.
Principal Investigator Affiliation Tulane University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus, COVID-19
Arms & Interventions

Arms

Experimental: Vaccine Concierge

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.

Other: Wait-List Control

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.

Interventions

Behavioral: - Vaccine Concierge

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.

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, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama

Birmingham, Alabama, 35233

Site Contact

Kiara Aaron, MSPH

[email protected]

205-996-5025