Opioid-use DisorderSTEPuPNCT04527926
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
A study testing STEPuP Intervention in people with Opioid-use Disorder and Pregnancy Related, run by University of Pittsburgh at 1 site in United States.
Trial summary
This research will test the effectiveness of a prenatal provider education and training program designed to facilitate provider adoption of evidence-based practices for the treatment of OUD during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Pregnancy Related
- What is being tested?
- STEPuP Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,022 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 30 Apr 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
Who may be able to join
- Providers:
- provides prenatal care (i.e. obstetricians, nurse midwives, advanced practice providers) at obstetric sites,
- provides care to pregnant women with OUD
- English speaking
- Patient:
- Maternal and child outcome data will be collected from the Electronic Health Record (EHR) and individual patients will not be recruited to participate in the randomized controlled trial (RCT).
Show all 10Show fewer
- Inclusion criteria for a small subset of pregnant women will be recruited for a one-time qualitative interview (n=50):
- meet The Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for OUD
- received care at participating sites while pregnant during the study time period and
- speak English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Project STEPuP: A Prenatal Provider Education and Training Program to Improve Medication-assisted Treatment Use During Pregnancy and Maternal and Child Health Outcomes
This research will test the effectiveness of a prenatal provider education and training program designed to facilitate provider adoption of evidence-based practices for the treatment of OUD during pregnancy. Findings from this research will provide high quality evidence about how to increase evidence-based treatment for pregnant women with OUD and subsequent maternal-child health outcomes.
Read the detailed description
The prevalence of opioid use disorder (OUD) during pregnancy has quadrupled over the past decade, as have maternal and neonatal morbidity and mortality related to substance use. Medication assisted treatment (MAT) use during pregnancy reduces adverse outcomes and is the recommended, evidence-based practice (EBP) for OUD treatment during pregnancy. Despite this, 40% of pregnant women with OUD do not receive MAT. Currently, there are no effective strategies to expand MAT access and availability for pregnant women, especially in rural, low-resource settings where maternal opioid use is disproportionately high. As an initial step to address this gap, the investigators engaged key stakeholders across a large health system in Pennsylvania to determine barriers and facilitators to expanding treatment services in high need, low-resource obstetric settings. The stakeholders identified a critical need for a women-centered, low resource, sustainable, provider-level intervention to facilitate the adoption of MAT in obstetric settings. Therefore, the investigators objective is to test the effectiveness of a prenatal provider education and training program designed to facilitate the adoption of EBP for OUD during pregnancy called Project STEPuP (Substance abuse Treatment and Education during pregnancy and Postpartum). Project STEPuP, grounded in preliminary and pilot work conducted by the research team, has 4 components designed to address barriers to MAT and EBP adoption: 1) a "hub and spoke," remotely supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs. To achieve this objective, the research team will conduct a cluster-randomized clinical trial across 12 obstetric sites in Pennsylvania and New York. Outcomes among 870 patients will be assessed during pregnancy, at delivery and through 1 year postpartum. The investigators central hypothesis is that Project STEPuP will facilitate EBP adoption, increase MAT utilization and improve health outcomes among pregnant and postpartum women with OUD and their children. Specifically, the investigators aim to: 1) Create organizational readiness to facilitate Project STEPuP implementation; 2) Assess the effect of Project STEPuP on provider adoption of EBP for OUD during pregnancy; and 3) Evaluate the effect of provider adoption of EBP on maternal and child health outcomes. The investigators research is significant by addressing the substantial knowledge gap of how to increase MAT use in pregnancy and innovative by examining the role that prenatal providers can play in expanding treatment access.
Study outcome measures refined in January 2024 to align with grant proposal and increase readability.
- Conditions
- Opioid-use Disorder, Pregnancy Related
- Being tested
- STEPuP Intervention, Usual Care
- Keywords
- Opioid-use Disorder, Medication-assisted Treatment, Pregnancy
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPuP InterventionBehavioural
Also called Project STEPuP(Substance abuse Treatment and Education during Pregnancy and Postpartum)
Project STEPup has 4 components designed to address barriers to MAT and EBP adoption: 1) a "hub and spoke" remotely-supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs.
Usual CareBehavioural
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| STEPuP Intervention | Experimental | STEPuP interventions Receives: Behavioral: STEPuP Intervention |
| Usual Care | Active comparator | Standard of Care Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Medication-assisted treatment (MAT) utilization
As measured by total count of weeks in pregnancy with any Medications for Opioid Use Disorder (MOUD) either buprenorphine or methadone, use during pregnancy
Measured: up to 1 year post delivery
Provider Provision of Buprenorphine
As measured by total number of patients within a prenatal practice with opioid use disorder that receive MOUD treatment (either buprenorphine or methadone)
Measured: up to 1 year post delivery
Secondary outcomes (5)
Hepatitis C Virus (HCV) Screening Rate
Number of participants screened for Hepatitis C Virus (HCV) as measured by related laboratory testing
Measured: during pregnancy (up to 40 weeks)
Human Immunodeficiency Virus (HIV) Screening Rate
Number of participants screened for Human Immunodeficiency Virus (HIV) as measured by related laboratory testing
Measured: during pregnancy (up to 40 weeks)
Mental Health Screening Rate
Number of participants who received a mental health screening test, Patient Health Questionaire-2 or Patient Health Questionaire-9 (PHQ-2 or PHQ-9)
Measured: during pregnancy (up to 40 weeks)
Contraceptive Utilization Rate
Number of participants utilizing postpartum contraceptive as measured by contraception prescription
Measured: delivery up to 1 year post delivery
Breastfeeding Rate
Number of participants breastfeeding as measured by feeding records from infant charts (yes/no)
Measured: delivery up to 1 year post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start30 Sep 2020
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 1,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Elizabeth Krans, MD, University of Pittsburgh
- Investigators
- Elizabeth Krans, MD, Principal investigator, UPMC Magee-Womens HospitalMarian Jarlenski, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527926
- Sponsor's protocol ID
- STUDY19070128
- Other IDs
- 1R01DA049759-01
- Acronym
- STEPuP
- Status last verified
- Jun 2026
- First submitted
- 18 Aug 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project STEPuP: A Prenatal Provider Education and Training Program to Improve Medication-assisted Treatment Use During Pregnancy and Maternal and Child Health Outcomes
- ClinicalTrials.gov ID
- NCT04527926
- Acronym / sponsor ID
- STEPuP / STUDY19070128
- Conditions
- Opioid-use Disorder, Pregnancy Related
- Keywords
- Opioid-use Disorder, Medication-assisted Treatment, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,022 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 Aug 2020 (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.
This research will test the effectiveness of a prenatal provider education and training program designed to facilitate provider adoption of evidence-based practices for the treatment of OUD during pregnancy. Findings from this research will provide high quality evidence about how to increase evidence-based treatment for pregnant women with OUD and subsequent maternal-child health outcomes.
Detailed description
The prevalence of opioid use disorder (OUD) during pregnancy has quadrupled over the past decade, as have maternal and neonatal morbidity and mortality related to substance use. Medication assisted treatment (MAT) use during pregnancy reduces adverse outcomes and is the recommended, evidence-based practice (EBP) for OUD treatment during pregnancy. Despite this, 40% of pregnant women with OUD do not receive MAT. Currently, there are no effective strategies to expand MAT access and availability for pregnant women, especially in rural, low-resource settings where maternal opioid use is disproportionately high. As an initial step to address this gap, the investigators engaged key stakeholders across a large health system in Pennsylvania to determine barriers and facilitators to expanding treatment services in high need, low-resource obstetric settings. The stakeholders identified a critical need for a women-centered, low resource, sustainable, provider-level intervention to facilitate the adoption of MAT in obstetric settings. Therefore, the investigators objective is to test the effectiveness of a prenatal provider education and training program designed to facilitate the adoption of EBP for OUD during pregnancy called Project STEPuP (Substance abuse Treatment and Education during pregnancy and Postpartum). Project STEPuP, grounded in preliminary and pilot work conducted by the research team, has 4 components designed to address barriers to MAT and EBP adoption: 1) a "hub and spoke," remotely supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs. To achieve this objective, the research team will conduct a cluster-randomized clinical trial across 12 obstetric sites in Pennsylvania and New York. Outcomes among 870 patients will be assessed during pregnancy, at delivery and through 1 year postpartum. The investigators central hypothesis is that Project STEPuP will facilitate EBP adoption, increase MAT utilization and improve health outcomes among pregnant and postpartum women with OUD and their children. Specifically, the investigators aim to: 1) Create organizational readiness to facilitate Project STEPuP implementation; 2) Assess the effect of Project STEPuP on provider adoption of EBP for OUD during pregnancy; and 3) Evaluate the effect of provider adoption of EBP on maternal and child health outcomes. The investigators research is significant by addressing the substantial knowledge gap of how to increase MAT use in pregnancy and innovative by examining the role that prenatal providers can play in expanding treatment access.
Study outcome measures refined in January 2024 to align with grant proposal and increase readability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPuP Intervention | Experimental | Behavioral: STEPuP InterventionSTEPuP interventions |
| Usual Care | Active comparator | Behavioral: Usual CareStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- provides prenatal care (i.e. obstetricians, nurse midwives, advanced practice providers) at obstetric sites,
- provides care to pregnant women with OUD
- English speaking
- Maternal and child outcome data will be collected from the Electronic Health Record (EHR) and individual patients will not be recruited to participate in the randomized controlled trial (RCT).
- Inclusion criteria for a small subset of pregnant women will be recruited for a one-time qualitative interview (n=50):
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| STEPuP InterventionAlso: Project STEPuP(Substance abuse Treatment and Education during Pregnancy and Postpartum)Project STEPup has 4 components designed to address barriers to MAT and EBP adoption: 1) a "hub and spoke" remotely-supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs. | Behavioural | STEPuP Intervention |
| Usual CareStandard of Care | Behavioural | Usual Care |
Primary outcome
Patient Medication-assisted treatment (MAT) utilization
Time frame: up to 1 year post delivery
As measured by total count of weeks in pregnancy with any Medications for Opioid Use Disorder (MOUD) either buprenorphine or methadone, use during pregnancy
Provider Provision of Buprenorphine
Time frame: up to 1 year post delivery
As measured by total number of patients within a prenatal practice with opioid use disorder that receive MOUD treatment (either buprenorphine or methadone)
5 secondary outcomes
Hepatitis C Virus (HCV) Screening Rate
Time frame: during pregnancy (up to 40 weeks)
Human Immunodeficiency Virus (HIV) Screening Rate
Time frame: during pregnancy (up to 40 weeks)
Mental Health Screening Rate
Time frame: during pregnancy (up to 40 weeks)
Contraceptive Utilization Rate
Time frame: delivery up to 1 year post delivery
Breastfeeding Rate
Time frame: delivery up to 1 year post delivery
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 4 Jun 2026.
- 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.
Elizabeth Krans, MD principal investigator
UPMC Magee-Womens Hospital
Marian Jarlenski, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPuP Intervention in people with Opioid-use Disorder and Pregnancy Related, run by University of Pittsburgh 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?
The sponsor lists 10 inclusion and 1 exclusion criteria. 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 4 Jun 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?
Patient Medication-assisted treatment (MAT) utilization (time frame: up to 1 year post delivery). The study lists 2 primary outcomes in all. 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 4 Jun 2026.