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NCT05818254 · ClinicalTrials.gov registry record · NA

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

A NA study of Systemic Lupus Erythematosus and Contraception, sponsored by Duke University.

Active
Registry status
NA
Development phase
14
Enrollment target
1
Study location

NCT05818254 is a NA study of Systemic Lupus Erythematosus and Contraception that is active but no longer recruiting, run by Duke University. The registered enrollment target is 14 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05818254, a NA study of Systemic Lupus Erythematosus and Contraception, is active but no longer recruiting, sponsored by Duke University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
14 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BEHAVIORAL HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention
  • BEHAVIORAL Routine Care

Study Locations (1)

Illinois

  • University of Chicago Medical Center - Chicago

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2024-10-07
Est. Completion 2026-08-01
Phase NA

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT05818254

The ClinicalTrials.gov registry entry for NCT05818254 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (96% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention is the first listed.

NCT05818254 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT05818254 about?

NCT05818254 is a clinical study titled "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 ...

What is the current status of trial NCT05818254?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 14 participants. The study started on 2024-10-07. Estimated completion is 2026-08-01.

What conditions does trial NCT05818254 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Contraception.

What interventions are being tested in trial NCT05818254?

The interventions under investigation include: HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention (BEHAVIORAL), Routine Care (BEHAVIORAL).

Who is sponsoring clinical trial NCT05818254?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05818254 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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