Clinical trial NCT06889831: WORTH Paths Intervention
Official title: Adaptation of a Digital Group-Based Intervention to Reduce Drug Use and Increase Contraceptive Use Among Reproductive-Aged Women Involved in Criminal Justice Systems
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use Disorder (SUD)
Sexual and Reproductive Health
Sexual Risk Behavior
Keywords: substance use disorder
Lead sponsor: Fairleigh Dickinson University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-03-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment - Participants will be randomly assigned to one of two groups:

* Intervention Group: Receives a digital intervention including facilitated group-based treatment via videoconference and interactive activities to reduce substance use and improve contraceptive use.
* Control Group: Receives a wellness intervention focusing on stress reduction, physical activity, and general health.

This is a pilot randomized controlled trial. The study will recruit 50 reproductive-aged women involved in criminal legal systems with substance use disorders and unmet need for contraception who will be randomly assigned to either the intervention (n=25) or the wellness control condition (n=25). Both arms involve facilitated group-based treatment via videoconference.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Women in the criminal legal system are more likely to experience substance use disorders and unintended pregnancy than women in the general public. However, they often face barriers to accessing substance use treatment and sexual and reproductive health services.

This study tests the feasibility and acceptability of Women on the Road to Health (WORTH) Promoting Access to Treatment, Health, and Support (Paths), a digital intervention adapted from the evidence-based CDC Best Practice HIV prevention intervention, Women on the Road to Health (WORTH), originally developed at Columbia University School of Social Work. WORTH Paths is designed to help reproductive-aged women in the criminal legal system with substance use disorders and unmet need for contraception reduce drug use and improve contraceptive use.

Participants (N=50) will be randomly assigned to one of two groups:

WORTH Paths Intervention Group - Participants will attend three virtual group sessions with facilitated videoconference sessions and self-paced digital activities focused on reducing drug use and increasing contraceptive use. They will also receive guidance on how to access and navigate health services.

Control Group - Participants will receive a virtual general wellness program that includes education on substance use and sexual and reproductive health but does not include skills-based training related to these topics. The focus will be on general wellness and stress reduction.

Both groups will receive resources for substance use treatment and sexual and reproductive health services.

Researchers will track changes in drug use and contraceptive use over three months. Participants will complete surveys and provide urine samples to confirm changes in drug use.

Primary aims:

Feasibility: Measured by session attendance, treatment completion, dropouts, and reasons for termination.

Acceptability: Measured by participant ease of use, helpfulness, and satisfaction.

Primary behavioral outcomes:

Self-reported drug use confirmed by urine drug tests. Contraceptive use, including initiation and consistent use.

Secondary behavioral outcome:

Linkage to substance use disorder treatment (measured by appointments made and sessions attended).

Detailed description: Many women involved in the criminal legal system experience substance use disorders and unintended pregnancy but face significant barriers to accessing and utilizing substance use treatment and sexual and reproductive health services. These barriers include limited social support, intimate partner violence, and challenges with self-advocacy and decision-making regarding substance use treatment and contraception. The siloed nature of healthcare services also makes it difficult for women to receive integrated care that addresses both substance use and sexual and reproductive health needs.

While some existing programs for women in the criminal legal system focus on HIV prevention through condom use, fewer interventions take a comprehensive approach to sexual and reproductive health by addressing all forms of contraception while also integrating substance use treatment strategies.

This study tests WORTH Paths, a digital intervention designed to reduce drug use and increase contraceptive use. WORTH Paths builds on Women on the Road to Health (WORTH), an evidence-based CDC Best Practice HIV prevention intervention originally developed at the Columbia University School of Social Work. While WORTH has been effective in increasing condom use, this new adaptation expands its focus to a broader range of contraceptive methods and strategies to support women in reducing drug use.

Study Design

This study is a randomized controlled trial (RCT). Participants will be randomly assigned to one of two groups:

1. WORTH Paths Intervention Group

   Participants in this group will receive the WORTH Paths program, a culturally tailored digital intervention designed to help women involved in the criminal legal system reduce substance use and improve contraceptive use. This intervention includes:
   * Three virtual group sessions led by trained facilitators via videoconferencing
   * Culturally relevant digital interactive activities, including animations, videos, and exercises to reinforce key skills
   * Education on a full range of contraceptive methods, including long-acting reversible contraception (LARC), barrier methods, and other effective forms of contraception at reducing unintended pregnancy and sexually transmitted infections
   * Guidance on accessing and navigating substance use treatment and reproductive healthcare services, including how to advocate for their needs within the healthcare system
   * Cognitive-behavioral and motivational interviewing (MI)-based activities to help participants develop personalized strategies for reducing substance use and improving reproductive health behaviors
   * Skill-building for self-regulation and behavioral strategies, including managing drug-related triggers, coping with relationship and environmental stressors, and setting personal health goals
   * Safety planning and decision-making strategies, with a focus on reducing interpersonal risks such as intimate partner violence and reproductive coercion
   * Participants in the intervention group will also receive resources for substance use treatment and sexual and reproductive health services, including referrals to local and online providers for contraception and substance use treatment.
2. Control Group (Wellness Program)

Participants in the control group will receive a general wellness program designed to provide support and education while excluding the behavioral skill-building components of the intervention. This program includes:

* Three virtual group sessions led by trained facilitators via videoconferencing
* Education about challenges in accessing substance use treatment and sexual and reproductive health services among women in the criminal legal system
* Guided mindfulness exercises, including meditation and relaxation techniques
* Stress management strategies, such as breathing exercises and coping mechanisms for managing emotional distress
* General wellness discussions on self-care and maintaining overall well-being
* Referrals and informational resources for substance use treatment and reproductive health services, but no structured training on how to navigate or advocate for care Unlike the intervention group, the control group will not receive training in behavioral change strategies related to substance use or contraceptive use.

Assessments \& Data Collection

All participants will complete:

* Baseline assessments and mail-in urine drug tests at enrollment
* Follow-up assessments and mail-in urine drug tests at 3 months
* Participants will report on drug use and contraceptive use through online surveys. Urine samples will biologically verify changes in drug use.

Eligibility Criteria

To participate, individuals must:

* Identify as a woman aged 18-44
* Have had criminal legal system involvement within the past year
* Meet DSM-5 criteria for current illicit substance use disorder as assessed by the Mini International Neuropsychiatric Interview (MINI)
* Have a past 30-day history of unmet need for contraception (not using contraception despite not wanting to become pregnant)
* Live in the New York metropolitan area (New York, New Jersey, or Connecticut)

Exclusion Criteria:

* Unable to give informed consent due to a medical condition or cognitive impairment
* Does not speak, read, or write in English
* Unwilling to follow study procedures Recruitment Methods
* Participants will be recruited through community-based organizations that serve formerly incarcerated women. Recruitment efforts will include:

Flyers and posters at community centers and shelters

* Announcements on community listservs
* Direct referrals from program staff
* Participation is completely voluntary, and participants may withdraw at any time. Privacy will be strictly protected.

Data Collection \& Safety Measures The study will use self-reported surveys and urine drug tests to measure changes in substance use.

Surveys will be completed securely online

* Data will be stored in a password-protected, encrypted system to ensure confidentiality
* Trained facilitators will monitor sessions and provide referrals if needed. If a participant experiences distress, they will be connected to counseling and substance use treatment resources.

Potential Benefits

While there is no guaranteed benefit, participants may:

* Gain new knowledge about contraception and reproductive health
* Receive support and strategies for reducing drug use and improving contraceptive use
* Obtain referrals for substance use treatment and sexual/reproductive health services (local and online)
* Improve self-efficacy and decision-making skills

Eligibility criteria: Inclusion Criteria:

* Female sex at birth
* Aged 18-44 years
* Past year criminal legal involvement (e.g., incarceration or community supervision)
* Meets criteria for current substance use disorder (SUD) as defined by DSM-5 and assessed by the Mini-International Neuropsychiatric Interview (MINI)
* Meets criteria for unmet need for contraception (capable of pregnancy, sexually active, does not want to become pregnant within the next year, but is currently not using contraception)
* Able to read, write, and speak English
* Willing and able to provide informed consent

Exclusion Criteria:

* Currently pregnant or actively trying to conceive
* Diagnosed infertility (e.g., menopause, tubal ligation, hysterectomy)
* Unable to provide informed consent due to significant cognitive impairment, mental health condition, or substance intoxication
* Unable or unwilling to meet study requirements (e.g., attend sessions, complete assessments)

Primary outcomes:
measure: Feasibility Measurement 1: Treatment Completion Rates
timeFrame: Immediately after Session 3 (Week 3)
measure: Feasibility Measurement 2: Session Completion Rates
timeFrame: Immediately after each session (Week 1, Week 2, Week 3)
measure: Feasibility Measurement 3: Dropout Rates and Reasons for Termination
timeFrame: Immediately after each session (Week 1, Week 2, Week 3)
measure: Feasibility Measurement 4: Technical Usability
timeFrame: Immediately after each session (Week 1, Week 2, Week 3)
measure: Feasibility Measurement 5: Qualitative Feasibility Assessment
timeFrame: 1 week after completion of Session 3 (Week 4)
measure: Acceptability Measurement 1: Ease of Use
timeFrame: Immediately after each session (Week 1, Week 2, Week 3)
measure: Acceptability Measurement 2: Helpfulness
timeFrame: Immediately after each session (Week 1, Week 2, Week 3)
measure: Acceptability Measurement 3: Satisfaction
timeFrame: Immediately after each session (Week 1, Week 2, Week 3)
measure: Acceptability Measurement 4: Qualitative Acceptability Assessment
timeFrame: 1 week after completion of Session 3 (Week 4)
measure: Change from baseline in self-reported primary illicit drug use at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from baseline in biologically confirmed illicit drug use at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from baseline in the number of participants initiating a contraceptive method highly effective at preventing unintended pregnancy at 3 months
timeFrame: Baseline and 3-month follow-up
measure: Change from baseline in effective contraceptive use at 3 months
timeFrame: Baseline and 3-month follow-up
Secondary outcomes:
measure: Number of participants linked to substance use treatment at 3 months
timeFrame: Baseline and 3-month follow-up
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Fairleigh Dickinson University
state: New Jersey
Study officials:
affiliation: Fairleigh Dickinson University
name: Melissa N Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References: