NOT_YET_RECRUITING
The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB
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.
Conditions:
🦠 Systemic Lupus Erythematosus 🦠 Contraception
🗓️ Study Start (Actual) 1 August 2024
🗓️ Primary Completion (Estimated) 31 March 2026
✅ Study Completion (Estimated) 31 March 2026
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * adult and/or pediatric clinical rheumatology providers within UCMC clinics
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 April 2023
  • First Submitted that Met QC Criteria 17 April 2023
  • First Posted 18 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 June 2024
  • Last Update Posted 21 June 2024
  • Last Verified June 2024