What side effects are associated with this type of intervention?

Common treatments for Lupus include hydroxychloroquine, glucocorticoids, and immunosuppressive agents such as azathioprine, belimumab, and anifrolumab. Hydroxychloroquine is generally well-tolerated but can cause gastrointestinal upset and, rarely, retinal toxicity. Glucocorticoids can lead to side effects like hyperglycemia, increased infection risk, bone loss, and neuropsychiatric issues. Immunosuppressive agents may cause bone marrow suppression, increased infection risk, and liver toxicity. Cyclophosphamide, used in severe cases, can result in bladder toxicity, infertility, and increased cancer risk. These side effects highlight the importance of careful monitoring and individualized treatment plans.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of systemic lupus erythematosus (SLE). Hydroxychloroquine (Plaquenil) is commonly used for its immunomodulatory effects and is considered safe during pregnancy. Belimumab (Benlysta) is a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS) and is used to reduce disease activity. Additionally, corticosteroids like prednisone and immunosuppressive agents such as mycophenolate mofetil (CellCept) and azathioprine (Imuran) are frequently used to manage severe symptoms and organ involvement. These treatments are relevant to the HOP-STEP program as they help control disease activity, which is crucial for pregnancy planning and maternal health in women with Lupus.

What other types of research exist?

One promising alternative to the HOP-STEP program is the implementation of peer mentoring interventions, such as the Peer Approaches to Self-Management (PALS) program. This program focuses on providing peer mentorship to improve self-management, reduce disease activity, and enhance health-related quality of life in African American women with SLE. Additionally, leveraging digital health platforms and telemedicine to provide continuous education and support to both patients and providers could also be a novel approach to improve pregnancy planning and maternal health outcomes in SLE patients.

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HOP-STEP Program for Lupus (HOP-STEPsIRB Trial)

N/A

Recruiting

Led By Megan E Clowse, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Provider Inclusion Criteria: Rheumatology providers who have seen at least 6 females 18-44 years old within the last year (at least 3 if provider has been at UCMC clinics for less than a year).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intervention period, up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to adapt and test the HOP-STEP program at a new location to help women with lupus plan their pregnancies and use contraception more effectively. The program educates healthcare providers and restructures clinics to offer better support, especially in high-minority, high-poverty areas.

Who is the study for?

This trial is for clinical rheumatology providers at the University of Chicago Medical Center. It aims to improve maternal health in women with lupus by educating providers on pregnancy planning and contraception.

What is being tested?

The HOP-STEP program, designed to boost provider confidence and ensure equitable care in pregnancy planning for lupus patients, is being tested against routine care practices to measure its effectiveness.

What are the potential side effects?

Since this intervention focuses on education rather than medication or medical procedures, there are no direct side effects associated with it.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intervention period, up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intervention period, up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and intervention period, up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Contraception Documentation

Secondary study objectives

Adoption: Providers that ever complete the HOP-STEP intervention

Degree of Adoption: Providers' completion of the HOP-STEP intervention

Effectiveness: ACR-aligned contraception

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Routine Care ProvidersExperimental Treatment1 Intervention

Care Providers in this arm will continue seeing patients as normal in clinic.

Group II: HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) ProvidersExperimental Treatment1 Intervention

HOP-STEP providers will inquire and document their patients about contraceptive usage and pregnancy interest, then provide personalized guidance on family planning.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Routine Care

2008

Completed Phase 4

~2270

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lupus include hydroxychloroquine, glucocorticoids, and immunosuppressive agents such as azathioprine and belimumab. Hydroxychloroquine works by modulating the immune system and reducing inflammation, which helps control lupus symptoms and prevent flares. Glucocorticoids are potent anti-inflammatory drugs that quickly reduce inflammation and immune activity but are used cautiously due to potential side effects. Immunosuppressive agents like azathioprine and belimumab help to further suppress the immune system, reducing disease activity and preventing organ damage. These treatments are essential for lupus patients as they help manage symptoms, prevent complications, and improve overall quality of life. In the context of the HOP-STEP trial, understanding these mechanisms is important for healthcare providers to offer tailored and effective pregnancy planning and management for women with lupus.

Response to placebo in non-renal, non-neuropsychiatric systemic lupus erythematosus: a systematic review and pooled analysis.Clinical trials in systemic lupus erythematosus (SLE): lessons from the past as we proceed to the future--the EULAR recommendations for the management of SLE and the use of end-points in clinical trials.