400 Participants Needed

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

(IMPACT Trial)

SM
EK
Overseen ByElizabeth Krans, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests MyPath, a tool designed to help women with substance use disorders make better decisions about birth control after giving birth. MyPath helps women think about their plans for more children, learn about their health, and choose the best birth control method for them. The goal is to improve their reproductive health outcomes by aligning contraceptive choices with their personal goals.

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 data supports the effectiveness of the MyPath Intervention treatment for postpartum birth control planning in women with substance use disorder?

Research suggests that women with opioid use disorder face unique challenges in accessing family planning services, and interventions like peer-led navigation can help address these needs by providing education and linking them to services. This approach has shown feasibility and acceptability, indicating potential effectiveness in improving access to family planning for this population.12345

How is the MyPath Intervention treatment different from other treatments for postpartum birth control planning in women with substance use disorder?

The MyPath Intervention is unique because it is a decision support tool specifically designed to help women with substance use disorder plan their postpartum birth control, addressing barriers like misconceptions and access issues that are common in this group.13467

Research Team

EK

Elizabeth Krans, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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
Speak English
See 1 more

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

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

Treatment Details

Interventions

  • MyPath Intervention
  • Usual care
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: MyPath InterventionExperimental Treatment1 Intervention
At the first visit participants randomized to this arm receive MyPath contraceptive decision tool.
Group II: Standard of CareActive Control1 Intervention
At the first visit participants randomized to this arm receive standard of care contraceptive counseling.

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
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]
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.
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]

References

Increasing access to family planning services among women receiving medications for opioid use disorder: A pilot randomized trial examining a peer-led navigation intervention. [2022]
Perspectives among women receiving medications for opioid use disorder: Implications for development of a peer navigation intervention to improve access to family planning services. [2023]
Knowledge of and concerns about long-acting reversible contraception among women in medication-assisted treatment for opioid use disorder. [2018]
Factors Affecting Contraception Access and Use in Patients With Opioid Use Disorder. [2021]
Contraceptive use and method choice among women with opioid and other substance use disorders: A systematic review. [2022]
Expanding Contraception Access for Women With Opioid-Use Disorder: A Qualitative Study of Opportunities and Challenges. [2023]
Factors associated with contraceptive use among postpartum women with substance use disorder. [2022]