NCT05818254

The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB

The HOP-STEP (Healthy Outcomes in Pregnancy With SLE Through Education of Providers) Intervention: Improving Maternal Health in Women With Lupus Through Improved Pregnancy Prevention and Planning sIRB

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

While the HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) program has been demonstrated to be effective in improving provider confidence, increasing contraception documentation, and facilitating equitable pregnancy planning care in a single sub-specialty clinic here at Duke, the delivery of HOP-STEP may need to be changed to increase its fit with the local context at the University of Chicago Medical Center (UCMC) and subsequent locations. Thus, the investigators will now fit the intervention into a high-minority, high-poverty academic rheumatology center, and later pilot it through a randomized trial to identify and overcome existing barriers to equitable pregnancy prevention and planning at another institution (The University of Chicago Medical Center). The objective of this study is to prepare for a multi-center trial of the HOP-STEP intervention by fitting and then piloting its implementation and measuring its potential impact on maternal outcomes.

Detailed description

The study creates opportunities for SLE (systemic lupus erythematosus) patients seeking reproductive care by restructuring the rheumatology clinic environment. Specifically through: Aim 1: Fit the implementation of the HOP-STEP Intervention to the local Rheumatology specialty clinic context with key stakeholder input. Aim 2: Evaluation of a pilot trial of the HOP-STEP Intervention. At the completion of this study, the investigators will know how to equitably implement and study the HOP-STEP Intervention within an academic rheumatology setting that cares for a high-minority, high-poverty population of women with SLE.

Conditions

• Systemic Lupus Erythematosus
• Contraception

Interventions

Type	Name	Description
BEHAVIORAL	HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention	The HOP-STEP Intervention is simple with 3-steps: (1) ascertain and document current pregnancy intention and contraceptive use, (2) patient and provider collaboratively arrive at her optimal contraceptive and/or pregnancy plan using a Decision Guide directed conversation, and (3) create a warm handoff with a patient-specific SLE risk assessment and guideline-aligned recommendations.
BEHAVIORAL	Routine Care	Providers will continue to provide reproductive healthcare in their current manner.

Timeline

• Start date: 2024-10-07
• Primary completion: 2026-01-31
• Completion: 2026-08-01
• First posted: 2023-04-18
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States