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Lupus Education Alliance Program

Lupus Education Alliance Program

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05243875
Acronym
LEAP
Enrollment
274
Registered
2022-02-17
Start date
2023-11-01
Completion date
2025-06-15
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Systemic Lupus Erythematosus

Brief summary

Randomized controlled trial of a COVID-19 behavioral and educational intervention for people with systemic lupus erythematosus (SLE).

Detailed description

Randomized controlled trial of a COVID-19 behavioral and educational intervention for people with systemic lupus erythematosus (SLE).

Interventions

BEHAVIORALLEAP Education + Navigation

COVID education involving providing information about COVID for people with SLE and CDC recommendations for testing, testing options (e.g., pharmacies, doctors' offices, at-home), treatment in the event of a positive COVID result, and current recommendations around vaccination for those with SLE; and (2) navigation, which involves individual tailoring of information about where and how to get tested, and where to get vaccinated, and when appropriate, guiding participants in scheduling testing and vaccination appointments.

BEHAVIORALLEAP Education

COVID education involving providing information about COVID for people with SLE and CDC recommendations for testing, testing options (e.g., pharmacies, doctors' offices, at-home), treatment in the event of a positive COVID result, and current recommendations around vaccination for those with SLE.

Sponsors

University of Alabama at Birmingham
CollaboratorOTHER
Ochsner Health System
CollaboratorOTHER
Louisiana State University Health Sciences Center in New Orleans
CollaboratorOTHER
Tulane University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

This is a two-arm study in which participants are randomized to an experimental (education + navigation) or comparison (education only) group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

18 years or older, ability to understand and speak English, diagnosis of SLE

Design outcomes

Primary

MeasureTime frameDescription
Incidence of COVID testing3 monthsParticipant-reported COVID testing
Incidence of COVID-19 Vaccination3 monthsParticipant-reported COVID vaccination

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026