MyPath Intervention for Postpartum Birth Control Planning in Women with Substance Use Disorder
(IMPACT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
Disqualifiers: Fetal death, Jail, Unsafe conditions, others
No Placebo Group
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?
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.
Trial 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 (Behavioral Intervention)
- Usual care (Behavioral Intervention)
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
Research Locations NearbySelect from list below to view details:
Magee Womens Hospital of UPMCPittsburgh, PA
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Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
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]High rates of unintended pregnancy occur among women with opioid use disorder (OUD). OUD treatment settings may provide an ideal opportunity to address the family planning needs of patients. However, few studies have rigorously evaluated interventions designed to address family planning needs in the OUD treatment setting. This study assessed the feasibility, acceptability, and preliminary efficacy of a peer-led navigation intervention designed to educate and link women receiving medications for OUD to family planning 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. [2023]Background Studies have consistently found high rates of unintended pregnancy among women with opioid use disorder (OUD). Few interventions have been developed to specifically engage and address the family planning (FP) needs of women in substance use disorder treatment. Objectives: Our goal was to collect formative qualitative data to identify the FP experiences, needs and service preferences of women receiving medications for OUD and to use these data to develop a FP education and navigation intervention that could be tested in diverse, resource-limited treatment settings. Methods: From August 2016 to April 2017, we conducted 21 guided qualitative interviews with women from two outpatient treatment clinics in Denver, Colorado. We recorded, transcribed, and coded all interviews. We then facilitated three focus groups (n = 16) from May to July 2017 to verify or challenge interview themes and to further inform the development of the FP intervention. Results: Most participants expressed ambivalence or low perceived risk regarding unintended pregnancy and desired more information about contraceptive methods. Many participants described mistrust or lack of engagement in the medical system and histories of trauma were a common barrier to seeking services. Focus group participants endorsed a peer-led FP navigation intervention and provided feedback to tailor existing FP educational materials to fit the specific needs of women in recovery. Conclusions/Importance: Results from this qualitative study suggest that women in recovery from OUD have unique, unmet FP education and service needs. These findings provide important information for the development of feasible and acceptable FP service delivery within diverse, resource-limited treatment settings and informed the development of a trauma-informed, peer-led FP education and navigation intervention that would be implemented in a subsequent phase of the study.
Knowledge of and concerns about long-acting reversible contraception among women in medication-assisted treatment for opioid use disorder. [2018]To assess interest in, concerns about and knowledge of long-acting reversible contraceptives (LARC) among women in medication-assisted treatment (MAT) for opioid use disorder who were at risk for unintended pregnancy.
Factors Affecting Contraception Access and Use in Patients With Opioid Use Disorder. [2021]Maternal opioid use disorder increased > 4-fold from 1999 to 2014 and is associated with poor maternal and fetal outcomes. Women with opioid use disorder are at 2 to 3 times greater risk for unintended pregnancy than the general population and may face additional barriers to accessing and effectively using contraception compared to women without opioid use disorder, particularly highly effective long-acting reversible contraception. Additionally, women with opioid use disorder tend to use less effective forms of contraception such as condoms alone. Barriers to contraceptive access include patient misconceptions or knowledge gaps regarding reproductive health and family planning, cost, intimate partner violence, fear of criminalization, difficulty accessing care, comorbid health conditions, and health care provider misconceptions or practice limitations. Strategies that may assist women with opioid use disorder in achieving their family planning goals include colocation of family planning services within opioid treatment facilities, optimization of patient care services to minimize the need for costly and/or time consuming follow-up, increasing provider education and awareness of best practices in family planning and opioid use disorder treatment, and providing patient-centered family planning education and counseling. Additional research is needed to identify and develop strategies that empower women who use opioids to effectively access and use their preferred contraceptive method.
Contraceptive use and method choice among women with opioid and other substance use disorders: A systematic review. [2022]To systematically review the literature on contraceptive use by women with opioid and other substance use disorders in order to estimate overall contraceptive use and to examine method choice given the alarmingly high rate of unintended pregnancy in this population.
Expanding Contraception Access for Women With Opioid-Use Disorder: A Qualitative Study of Opportunities and Challenges. [2023]As almost nine in ten pregnancies among women with opioid use disorder (OUD) are unintended, expanding access to contraception is an underutilized but potentially effective strategy in increasing reproductive agency and reducing the overall burden of neonatal abstinence syndrome. We aimed to identify where and how contraceptive services could be integrated into existing points-of-contact for women with OUD.
Factors associated with contraceptive use among postpartum women with substance use disorder. [2022]Rates of unintended pregnancy among women with substance use disorder (SUD) are much higher than the general reproductive-age population, suggesting lower rates of contraceptive use. This study aims to determine the prevalence of contraceptive use in postpartum women with SUD and identify factors associated with its use.