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NCT05818254: HOP-STEPsIRB
The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB
NA trial testing HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention in Systemic Lupus Erythematosus in 14 participants. Participants enrolled and being followed up; not accepting new ones.
31 January 2026
Quick facts
| Lead sponsor | Duke University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 14 |
| Start date | 7 October 2024 |
| Primary completion | 31 January 2026 |
| Estimated completion | 1 August 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention
- Routine Care
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
- Contraception — all drugs for Contraception →
Sponsor
Duke University
Who can join
18 and older, any sex, with Systemic Lupus Erythematosus or Contraception. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05818254
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05818254 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Duke University
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05818254.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing