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Systemic Lupus ErythematosusHOP-STEPsIRBNCT05818254

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

A study testing HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention and Routine Care in people with Systemic Lupus Erythematosus and Contraception, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Systemic Lupus Erythematosus, Contraception
What is being tested?
HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention and Routine Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
7 Oct 2024to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Provider Inclusion Criteria: Rheumatology providers who have seen at least 6 females 18-44 years old within the last year (at least 3 if provider has been at UCMC clinics for less than a year).

Exclusion Criteria: Rheumatology Fellows*. Does not consent to join the study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Chicago Medical Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: The HOP-STEP (Healthy Outcomes in Pregnancy With SLE Through Education of Providers) Intervention: Improving Maternal Health in Women With Lupus Through Improved Pregnancy Prevention and Planning 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.

Read the detailed description

The study creates opportunities for SLE (systemic lupus erythematosus) patients seeking reproductive care by restructuring the rheumatology clinic environment. Specifically through:

Aim 1: Fit the implementation of the HOP-STEP Intervention to the local Rheumatology specialty clinic context with key stakeholder input.

Aim 2: Evaluation of a pilot trial of the HOP-STEP Intervention. At the completion of this study, the investigators will know how to equitably implement and study the HOP-STEP Intervention within an academic rheumatology setting that cares for a high-minority, high-poverty population of women with SLE.

Being tested
HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention, Routine Care
Keywords
Family Planning, SLE, Contraception
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • Routine CareBehavioural

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

Study groups in NCT05818254
Study groupRoleWhat they receive
Routine Care ProvidersExperimentalCare Providers in this arm will continue seeing patients as normal in clinic.
Receives: Behavioral: Routine Care
HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) ProvidersExperimentalHOP-STEP providers will inquire and document their patients about contraceptive usage and pregnancy interest, then provide personalized guidance on family planning.
Receives: Behavioral: HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intervention Period, up to 12 months

Secondary outcomes (12)
  1. Reach: Pregnancy intention documentation

    Yes/No: Documentation of the patient's pregnancy intention during patient visit. 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.

    Measured: Intervention Period, up to 12 months

  2. Reach: Contraceptive Counseling

    Yes/No: Documentation of any contraceptive counseling during patient visit. Denominator: all eligible patients.

    Measured: Intervention Period, up to 12 months

  3. Reach: Pregnancy planning

    Yes/No: Documentation of any pregnancy planning during patient visit. Denominator: all eligible patients.

    This is extracted from the patient's medical record. This will also be analyzed by patient-level characteristics: race, age, teratogen use.

    Measured: Intervention Period, up to 12 months

  4. Effectiveness: ACR-aligned contraception

    Yes/No: documentation of use of contraception aligned with ACR RHG a rheumatology clinic visit within 6 months of a visit in the Intervention Period. ACR RHG guidelines recommend:

    1. Any woman with SLE: avoid estrogen-containing patch;
    2. Those with prior blood clot, positive antiphospholipid antibodies, or nephrotic syndrome: avoid contraceptives that increase thrombotic risk (pills with estrogen, ring, patch, or depot-medroxyprogesterone);
    3. Those with highly active SLE: avoid contraceptives that contain estrogen (pills with estrogen, ring, patch); and
    4. Those not medically ready for pregnancy: effective or highly effective contraception. Denominator: Eligible patients excluding pregnant women or women who have a documented pregnancy intention AND are medically optimized for pregnancy. This will be coded based on information extracted from the patient's medical record.

    Measured: Intervention Period, up to 12 months

  5. Effectiveness: Effective and/or highly effective contraception

    Yes/No: documentation of use of an effective or highly effective contraception at a Rheumatology clinic visit in the Intervention Period. Effective and highly effective contraception includes hormonal contraception, long-acting reversible contraception, and permanent contraception or the physical inability to get pregnant (menopause, hysterectomy, oophorectomy). Denominator: Eligible patients excluding pregnant women or women who have a documented pregnancy intention AND are medically optimized for pregnancy. This is extracted from the patient's medical record.

    Measured: Intervention Period, up to 12 months

  6. Effectiveness: Change from no contraception or ineffective contraception to effective and/or highly effective contraception

    Yes/No: documentation of use of an effective or highly effective contraception at any Rheumatology clinic visit within 6 months of a visit in the Intervention Period. Denominator: Eligible non-pregnant women who have documentation of either no contraceptive use or low efficacy contraception at a prior rheumatology visit in the Intervention Period. Women without contraception documentation are excluded from this analysis. Effective and highly effective contraception includes hormonal contraception, long-acting reversible contraception, and permanent contraception or the physical inability to get pregnant (menopause, hysterectomy, oophorectomy). Low Efficacy Contraception includes condom, diaphragm, sponge, cervical cap, spermicide, fertility awareness, withdrawal method. This is extracted from the patient's medical record.

    Measured: Intervention Period, up to 12 months

  7. Effectiveness: Pregnancy when women is medically optimized for pregnancy

    Yes/No: conception is aligned with ACR recommendations. Denominator: All pregnancies conceived within 6 months of a rheumatology visit in the Intervention Period.

    Medically optimized for pregnancy is defined as meeting all 3 criteria:

    1. Urine protein:creatinine ratio measured within 3 months before or after conception and with <1g of proteinuria
    2. Not taking any rheumatic teratogens at conception (mycophenolate or mycophenolic acid, methotrexate, leflunamide, cyclophosphamide, thalidomide or lenalidomide)
    3. Continued pregnancy-compatible SLE medications after conception (most commonly prednisone, hydroxychloroquine, and/or azathioprine; also tacrolimus, cyclosporin, and/or colchicine) This is extracted from the patient's medical record.

    Measured: Intervention Period, up to 12 months

  8. Adoption: Providers that ever complete the HOP-STEP intervention

    Yes/No: provider that has documentation of completing the whole HOP-STEP intervention with one or more of their patients. Completing the whole HOP-STEP Intervention is defined as documenting all three components of the intervention: current contraception, pregnancy intention, and ACR-aligned contraception and/or pregnancy planning counseling. This is extracted from the provider's patients' medical records and will also be examined by the provider's race, age, gender, and proportion of SLE patients within a provider's practice.

    Measured: Intervention Period, up to 12 months

  9. Degree of Adoption: Providers' completion of the HOP-STEP intervention

    Per provider, the number of eligible patients who received the whole HOP-STEP Intervention at one or more of their visits. Denominator: eligible patients cared for by the provider during the Intervention Period. This is extracted from the provider's patients' medical records and will also be examined by the provider's race, age, gender, and proportion of SLE patients within a provider's practice.

    Measured: Intervention Period, up to 12 months

  10. Fidelity to the ACR RHG contraception recommendations

    Yes/No: contraception recommendations aligned with the ACR RHG. Denominator: eligible patients who received any contraception recommendation. This is extracted from the patient's medical record. This will also be analyzed by patient-level characteristics: race, age, teratogen use.

    Measured: Intervention Period, up to 12 months

  11. Fidelity to the ACR RHG pregnancy medications recommendations

    Yes/No: pregnancy planning recommendations aligned with the ACR RHG. Denominator: eligible patients who received any pregnancy planning. This is extracted from the patient's medical record.

    Measured: Intervention Period, up to 12 months

  12. FRAME system to document local changes to the Implementation

    1.) when and how a change is made, 2.) whether the change was planned or not, 3.) who determined that the change could be made, 4.) what the change was, 5.) where within the delivery the change was made, 6.) the type of content- or context-level change, 7.) the degree that the change is consistent with intervention fidelity, and 8.) the reasons for the change, including intended impact on equity of reach, adoption, effectiveness, and/or maintenance of the HOP-STEP intervention.

    Measured: Intervention Period, up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start7 Oct 2024
  3. Primary completion31 Jan 2026
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05818254
Sponsor's protocol ID
Pro00112931
Other IDs
1R01AR082673
Acronym
HOP-STEPsIRB
Status last verified
May 2026
First submitted
5 Apr 2023
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention and Routine Care in people with Systemic Lupus Erythematosus and Contraception, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contraception Documentation (time frame: Intervention Period, up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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