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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: Active NA study of Systemic Lupus Erythematosus and Contraception, sponsored by Duke University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Yes/No: Documentation of contraception use during patient visit; includes if the provider documents that the patient does not use any contraception. This is extracted from the patient's medical record and is part of the HOP-STEP intervention. This will also be analyzed by patient-level characteristics: race, age, teratogen use. Denominator: all eligible patients.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2024-10-07 |
| Est. Completion | 2026-08-01 |
| Phase | NA |
What the registry record for NCT05818254 still lists
NCT05818254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05818254's enrollment target sits among peer trials
14 94th of 99 higher than 6 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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