Systemic Lupus ErythematosusLEAPNCT05243875
Lupus Education Alliance Program
A study testing LEAP Education + Navigation and LEAP Education in people with Systemic Lupus Erythematosus and COVID-19, run by Tulane University at 1 site in United States.
Trial summary
Randomized controlled trial of a COVID-19 behavioral and educational intervention for people with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, COVID-19
- What is being tested?
- LEAP Education + Navigation and LEAP Education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
18 years or older, ability to understand and speak English, diagnosis of SLE
Trial locations and contacts
1 site in 1 country.
About this study
Randomized controlled trial of a COVID-19 behavioral and educational intervention for people with systemic lupus erythematosus (SLE).
Read the detailed description
Randomized controlled trial of a COVID-19 behavioral and educational intervention for people with systemic lupus erythematosus (SLE).
- Conditions
- Systemic Lupus Erythematosus, COVID-19
- Being tested
- LEAP Education + Navigation, LEAP Education
- Medical subject headings
- Lupus Erythematosus, Systemic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEAP Education + NavigationBehavioural
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.
LEAP EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education / Navigation | Experimental | 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. Receives: Behavioral: LEAP Education + Navigation |
| Education Only | Active comparator | 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. Receives: Behavioral: LEAP Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of COVID testing
Participant-reported COVID testing
Measured: 3 months
Incidence of COVID-19 Vaccination
Participant-reported COVID vaccination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Nov 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm study in which participants are randomized to an experimental (education + navigation) or comparison (education only) group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Ochsner Health System, Louisiana State University Health Sciences Center in New Orleans, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243875
- Sponsor's protocol ID
- Pro00073870
- Other IDs
- 3R01AR065493-07S2
- Acronym
- LEAP
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lupus Education Alliance Program
- ClinicalTrials.gov ID
- NCT05243875
- Acronym / sponsor ID
- LEAP / Pro00073870
- Conditions
- Systemic Lupus Erythematosus, COVID-19
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Ochsner Health System, Louisiana State University Health Sciences Center in New Orleans, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-arm study in which participants are randomized to an experimental (education + navigation) or comparison (education only) group.
| Arm | Type | Receives |
|---|---|---|
| Education / Navigation | Experimental | Behavioral: LEAP Education + NavigationCOVID 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 comparator | Behavioral: LEAP EducationCOVID 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEAP Education + NavigationCOVID 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. | Behavioural | Education / Navigation |
| LEAP EducationCOVID 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. | Behavioural | Education Only |
Primary outcome
Incidence of COVID testing
Time frame: 3 months
Participant-reported COVID testing
Incidence of COVID-19 Vaccination
Time frame: 3 months
Participant-reported COVID vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Systemic Lupus Erythematosus
Active, not recruitingPhase 4
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
RecruitingPhase 1
Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis
Lupus Nephritis (LN)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEAP Education + Navigation and LEAP Education in people with Systemic Lupus Erythematosus and COVID-19, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of COVID testing (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.