NCT05818254

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Oct 2024Aug 2026

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 7, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

April 5, 2023

Last Update Submit

May 4, 2026

Conditions

Systemic Lupus ErythematosusContraception

Keywords

Family PlanningSLEContraception

Outcome Measures

Primary Outcomes (1)

  • Contraception Documentation

    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.

    Intervention Period, up to 12 months

Secondary Outcomes (12)

  • Reach: Pregnancy intention documentation

    Intervention Period, up to 12 months

  • Reach: Contraceptive Counseling

    Intervention Period, up to 12 months

  • Reach: Pregnancy planning

    Intervention Period, up to 12 months

  • Effectiveness: ACR-aligned contraception

    Intervention Period, up to 12 months

  • Effectiveness: Effective and/or highly effective contraception

    Intervention Period, up to 12 months

  • +7 more secondary outcomes

Study Arms (2)

Routine Care Providers

EXPERIMENTAL

Care Providers in this arm will continue seeing patients as normal in clinic.

Behavioral: Routine Care

HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Providers

EXPERIMENTAL

HOP-STEP providers will inquire and document their patients about contraceptive usage and pregnancy interest, then provide personalized guidance on family planning.

Behavioral: HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention

Interventions

Routine CareBEHAVIORAL

Providers will continue to provide reproductive healthcare in their current manner.

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

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.

HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

PregnancyMethods

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaInvestigative Techniques

Study Officials

  • Megan E Clowse, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

October 7, 2024

Primary Completion

January 31, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)