Study Stopped
Early Termination
Lupus Education Alliance Program
LEAP
1 other identifier
interventional
274
1 country
1
Brief Summary
Randomized controlled trial of a COVID-19 behavioral and educational intervention for people with systemic lupus erythematosus (SLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2021
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2025
CompletedAugust 3, 2025
July 1, 2025
1.6 years
November 15, 2021
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of COVID testing
Participant-reported COVID testing
3 months
Incidence of COVID-19 Vaccination
Participant-reported COVID vaccination
3 months
Study Arms (2)
Education / Navigation
EXPERIMENTALCOVID 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.
Education Only
ACTIVE COMPARATORCOVID 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.
Interventions
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.
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.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Tulane Universitylead
- University of Alabama at Birminghamcollaborator
- Ochsner Health Systemcollaborator
- Louisiana State University Health Sciences Center in New Orleanscollaborator
Study Sites (1)
Tulane University
New Orleans, Louisiana, 70112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 15, 2021
First Posted
February 17, 2022
Study Start
November 1, 2023
Primary Completion
June 15, 2025
Study Completion
June 15, 2025
Last Updated
August 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
De-identified data will be made available to researchers outside the study team after completion of the primary analyses. 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.