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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Systemic Lupus Erythematosus, Contraception
- 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 group | Role | What they receive |
|---|---|---|
| Routine Care Providers | Experimental | Care 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) Providers | Experimental | HOP-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.
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)
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
Reach: Contraceptive Counseling
Yes/No: Documentation of any contraceptive counseling during patient visit. Denominator: all eligible patients.
Measured: Intervention Period, up to 12 months
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
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:
- Any woman with SLE: avoid estrogen-containing patch;
- 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);
- Those with highly active SLE: avoid contraceptives that contain estrogen (pills with estrogen, ring, patch); and
- 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
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
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
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:
- Urine protein:creatinine ratio measured within 3 months before or after conception and with <1g of proteinuria
- Not taking any rheumatic teratogens at conception (mycophenolate or mycophenolic acid, methotrexate, leflunamide, cyclophosphamide, thalidomide or lenalidomide)
- 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
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
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
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
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
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.
- First posted18 Apr 2023
- Study start7 Oct 2024
- Primary completion31 Jan 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Chicago
- Responsible party
- Sponsor
- Investigators
- Megan E Clowse, MD, Principal investigator, Duke University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05818254
- Acronym / sponsor ID
- HOP-STEPsIRB / Pro00112931
- Conditions
- Systemic Lupus Erythematosus, Contraception
- Keywords
- Family Planning, SLE, Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Chicago
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care Providers | Experimental | Behavioral: Routine CareCare Providers in this arm will continue seeing patients as normal in clinic. |
| HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Providers | Experimental | Behavioral: HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) InterventionHOP-STEP providers will inquire and document their patients about contraceptive usage and pregnancy interest, then provide personalized guidance on family planning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) InterventionThe 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. | Behavioural | HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Providers |
| Routine CareProviders will continue to provide reproductive healthcare in their current manner. | Behavioural | Routine Care Providers |
Primary outcome
Contraception Documentation
Time frame: Intervention Period, up to 12 months
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.
12 secondary outcomes
Reach: Pregnancy intention documentation
Time frame: Intervention Period, up to 12 months
Reach: Contraceptive Counseling
Time frame: Intervention Period, up to 12 months
Reach: Pregnancy planning
Time frame: Intervention Period, up to 12 months
Effectiveness: ACR-aligned contraception
Time frame: Intervention Period, up to 12 months
Effectiveness: Effective and/or highly effective contraception
Time frame: Intervention Period, up to 12 months
Effectiveness: Change from no contraception or ineffective contraception to effective and/or highly effective contraception
Time frame: Intervention Period, up to 12 months
Effectiveness: Pregnancy when women is medically optimized for pregnancy
Time frame: Intervention Period, up to 12 months
Adoption: Providers that ever complete the HOP-STEP intervention
Time frame: Intervention Period, up to 12 months
Degree of Adoption: Providers' completion of the HOP-STEP intervention
Time frame: Intervention Period, up to 12 months
Fidelity to the ACR RHG contraception recommendations
Time frame: Intervention Period, up to 12 months
Fidelity to the ACR RHG pregnancy medications recommendations
Time frame: Intervention Period, up to 12 months
FRAME system to document local changes to the Implementation
Time frame: Intervention Period, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- HOP-STEP websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan E Clowse, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
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.