MyPath Intervention for Postpartum Birth Control Planning in Women with Substance Use Disorder

(IMPACT Trial)

Overseen By Elizabeth Krans, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Fetal death, Jail, Unsafe conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a new decision support tool, MyPath, can assist women with substance use disorders (SUDs) in making birth control decisions after childbirth. Participants will either use the MyPath tool or receive standard contraceptive counseling to compare outcomes. Women who are pregnant or have recently given birth at MWH and have a diagnosed substance use disorder may qualify for this study. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance decision-making tools for women with SUDs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your healthcare provider.

What prior data suggests that the MyPath Intervention is safe for postpartum contraceptive decision-making?

Research shows that the MyPath Intervention is an online tool designed to help people make informed choices about their reproductive health. It is patient-centered, focusing on the user's needs and preferences. Studies on MyPath have not found any safety issues, as it is a decision support tool, not a medication or medical device. This means it is generally safe to use, with no harmful effects reported. Since MyPath provides information and support, it is considered safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MyPath Intervention because it offers a personalized approach to postpartum birth control planning for women with substance use disorders. Unlike the standard of care, which typically involves general contraceptive counseling, MyPath uses a decision tool tailored to individual needs and circumstances. This customized approach aims to improve decision-making and satisfaction with contraceptive choices, potentially leading to better health outcomes for this specific group of women.

What evidence suggests that the MyPath Intervention could be effective for postpartum birth control planning in women with substance use disorder?

Research has shown that the MyPath Intervention is a new online tool designed to help women with substance use issues make informed birth control choices after childbirth. Participants in this trial may receive the MyPath Intervention, which offers personalized information and support to help users achieve their family planning goals. Although limited data exists on MyPath's effectiveness due to its novelty, its user-focused approach aims to enhance decision-making. Early feedback from users suggests that MyPath could aid in planning birth control after childbirth. This innovative tool operates on the principle that better information leads to better decisions. ^{1 3 6 7 8}

Who Is on the Research Team?

Elizabeth Krans, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for new mothers aged 18 or older who have just given birth at Magee-Womens Hospital, speak English, and meet the criteria for substance use disorder as confirmed by medical records or urine tests. Women with fetal or neonatal death, severe psychiatric conditions requiring urgent treatment, or non-DSM-V level substance use are excluded.

Inclusion Criteria

I am a new mother and I am 18 years old or older.

Delivered at Magee-Womens Hospital

Meet DSM-V criteria for substance use disorder confirmed by diagnostic coding in the patient's medical record and/or urine toxicology screen (UDS) found in the medical record

Exclusion Criteria

The baby died before or shortly after birth.

Severe psychiatric condition in need of immediate treatment or legal action that could interfere with participation (e.g. incarceration)

You use substances, like marijuana, for recreational purposes, but you do not meet the criteria for a Substance Use Disorder (SUD) as defined by the DSM-V.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the MyPath contraceptive decision tool or standard of care counseling

Immediate postpartum period

1 visit (in-person)

Follow-up

Participants are monitored for contraceptive utilization and reproductive health outcomes

18 months

Multiple visits (in-person and virtual)

Evaluation

Qualitative interviews and process evaluation data collection to identify barriers and facilitators

Concurrent with follow-up

What Are the Treatments Tested in This Trial?

Interventions

• MyPath Intervention
• Usual care

Trial Overview The study is testing MyPath, a new tool designed to help postpartum women with substance use disorders make decisions about birth control. It will be compared to the usual care these women receive to see if it makes a difference in their contraceptive choices.

How Is the Trial Designed?

Group I: MyPath Intervention Experimental Treatment 1 Intervention

At the first visit participants randomized to this arm receive MyPath contraceptive decision tool.

Group II: Standard of Care Active Control 1 Intervention

At the first visit participants randomized to this arm receive standard of care contraceptive counseling.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Maternal opioid use disorder has significantly increased, leading to a higher risk of unintended pregnancies and poor outcomes for both mothers and babies, highlighting the need for effective family planning strategies.

Women with opioid use disorder face unique barriers to accessing contraception, often resulting in the use of less effective methods; strategies such as integrating family planning services into opioid treatment facilities and enhancing provider education could improve access and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Affecting Contraception Access and Use in Patients With Opioid Use Disorder. Stone, RH., Griffin, B., Fusco, RA., et al.[2021]

Only 36.3% of postpartum women with substance use disorder (SUD) were using contraception, indicating a significant gap in contraceptive use among this population of 353 women studied from 2016 to 2019.

Women who attended postpartum visits and those using medication for opioid use disorder (MOUD) were significantly more likely to use contraception, suggesting that healthcare interventions during the perinatal period can improve contraceptive access and usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with contraceptive use among postpartum women with substance use disorder. Shelton, D., Ramage, M., Hughes, P., et al.[2022]

The peer-led family planning navigation intervention was feasible and well-accepted among women with opioid use disorder (OUD), with 93% of participants completing the first session and 90% finding the topics important.

At six months, 36% of women in the intervention group attended a family planning visit compared to only 14% in the usual care group, indicating the intervention's preliminary efficacy in improving access to family planning services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing access to family planning services among women receiving medications for opioid use disorder: A pilot randomized trial examining a peer-led navigation intervention. Rinehart, DJ., Stowell, M., Collings, A., et al.[2022]

A survey of 83 women in medication-assisted treatment for opioid use disorder revealed low interest in long-acting reversible contraceptives (LARCs), with only 41% likely to use IUDs and 27% for implants, despite high awareness of these methods.

Participants expressed significant concerns about side effects and the insertion/removal process of LARCs, indicating a need for better education on the safety and effectiveness of these contraceptive options, particularly regarding their superior efficacy compared to other methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge of and concerns about long-acting reversible contraception among women in medication-assisted treatment for opioid use disorder. Matusiewicz, AK., Melbostad, HS., Heil, SH.[2018]

Integrating contraceptive services into existing support systems for women with opioid use disorder (OUD) could significantly enhance reproductive health and reduce unintended pregnancies, which are prevalent in this population.

Six key themes were identified for effective integration: addressing unmet needs, providing affordable contraception, ensuring accessibility, offering patient-centered care, employing qualified providers, and utilizing peer educators, highlighting both the potential benefits and challenges of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding Contraception Access for Women With Opioid-Use Disorder: A Qualitative Study of Opportunities and Challenges. Hurley, EA., Duello, A., Finocchario-Kessler, S., et al.[2023]

A systematic review of 24 studies found that women with opioid and other substance use disorders have a median contraceptive use rate of 55%, which is significantly lower than the 81% rate in non-drug-using populations.

Condoms were the most commonly used contraceptive method (62%), but more effective methods like implants and IUDs were used by only 8%, indicating a significant unmet need for effective contraception in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraceptive use and method choice among women with opioid and other substance use disorders: A systematic review. Terplan, M., Hand, DJ., Hutchinson, M., et al.[2022]

Women with opioid use disorder (OUD) often have unmet family planning (FP) needs, expressing ambivalence about unintended pregnancy and a desire for more information on contraceptive methods, based on qualitative interviews with 21 participants.

The study highlighted the importance of a peer-led FP navigation intervention tailored to the specific needs of women in recovery, addressing barriers such as mistrust in the medical system and trauma histories, which can hinder access to FP services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives among women receiving medications for opioid use disorder: Implications for development of a peer navigation intervention to improve access to family planning services. Stowell, MA., Thomas-Gale, T., Jones, HE., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04939012?tab=history&a=14

Record History | ver. 14: 2025-02-07 | NCT04939012 This is a study to determine the effect of a novel patient-centered, reproductive planning decision support tool developed by the research team called MyPath on ...

2. reporter.nih.gov reporter.nih.gov/search/WoJJrOT_EkiAu7fUY5SGXQ/project-details/11067737

RePORT RePORTER - National Institutes of Health (NIH) | This research will determine the effect of a novel, patient-centered, reproductive planning decision support tool called MyPath on postpartum contraceptive ...

3. pcrhp.ucsf.edu pcrhp.ucsf.edu/mypath

MyPath - Person Centered Reproductive Health Program MyPath is an online tool designed to empower individuals to get the information and support they need to achieve their reproductive goals.

4. withpower.com withpower.com/trial/phase-substance-related-disorders-8-2021-22fc4

MyPath Intervention for Postpartum Birth Control Planning in ... This trial tests MyPath, a tool designed to help women with substance use disorders make better decisions about birth control after giving birth.

5. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-261-postpartum-care.pdf

Postpartum Care up to 1 Year After Pregnancy The information in this report is intended to help healthcare decision makers—patients and clinicians, health system leaders, and policymakers, among others— ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04627805

Evaluating MyPath to Enhance Reproductive Autonomy ... MyPath is a reproductive decision support tool that utilizes a patient-centered approach to help women frame their reproductive decisions in the context of ...

7. ctv.veeva.com ctv.veeva.com/study/implementation-of-a-patient-centered-reproductive-planning-decision-support-tool-mypath-among-wom

Implementation of a Patient-centered, Reproductive Planning ... ... planning decision support tool developed by the research team called MyPath on postpartum contraceptive decision-making among women with SUDs.

8. reporter.nih.gov reporter.nih.gov/search/OGSYTXWBXEutmGKpVAAj7Q/project-details/11082197

MyPath We developed “MyPath,” a novel patient-facing web-based decision support tool, to address gaps in reproductive planning services in VA primary care. MyPath's ...