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Behavioral Intervention

Education and Navigation Program for Lupus (LEAP Trial)

N/A

Recruiting

Led By David H Chae, Sc.D., M.A.

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Living with systemic lupus erythematosus (SLE)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

LEAP Trial Summary

This trial tests if an educational program can increase COVID testing/vaccination among people with lupus and their social networks.

Who is the study for?

This trial is for adults over 18 living with systemic lupus erythematosus (SLE) in metropolitan Birmingham, Alabama. Participants must be able to speak and understand English. Those without a confirmed SLE diagnosis, under 18, or living outside the specified area cannot join.Check my eligibility

What is being tested?

The study aims to compare the effectiveness of two approaches: one that provides only education about COVID-19 testing and vaccination, and another that includes navigation assistance to help people with SLE get tested or vaccinated against COVID-19.See study design

What are the potential side effects?

Since this trial focuses on education and navigation interventions rather than medical treatments, there are no direct side effects associated with drugs or medical procedures.

LEAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have systemic lupus erythematosus (SLE).

LEAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of COVID testing

Incidence of COVID-19 Vaccination

LEAP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NavigationExperimental Treatment1 Intervention

COVID education for people with lupus and tailored guidance in vaccination and testing for COVID and making appointments.

Group II: EducationActive Control1 Intervention

COVID education for people with lupus.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Navigation

2013

Completed Phase 4

~3660

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansOTHER

114 Previous Clinical Trials

43,701 Total Patients Enrolled

Tulane UniversityLead Sponsor

115 Previous Clinical Trials

226,002 Total Patients Enrolled

Xavier University of Louisiana.OTHER

6 Previous Clinical Trials

2,328 Total Patients Enrolled

Media Library

Vaccine Concierge (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05243875 — N/A

Lupus Research Study Groups: Navigation, Education

Lupus Clinical Trial 2023: Vaccine Concierge Highlights & Side Effects. Trial Name: NCT05243875 — N/A

Vaccine Concierge (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05243875 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any more participants being taken into this research trial?

"That is accurate. According to information provided on clinicaltrials.gov, this medical trial began recruiting participants on February 1st 2023 and will continue until 800 patients are recruited from a single research centre."

Answered by AI

What is the current enrollment for this research project?

"Right. Data hosted on clinicaltrials.gov confirms that this study, which was initially posted in February of 2023, is currently recruiting participants. In total, 800 people must be enrolled at one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lupus Education Alliance Program

David Chae 2023. "Lupus Education Alliance Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05243875.

All > Systemic Lupus Erythematosus > Coronavirus