WORTH Paths Intervention

Adaptation of a Digital Group-Based Intervention to Reduce Drug Use and Increase Contraceptive Use Among Reproductive-Aged Women Involved in Criminal Justice Systems

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).

Study Overview

• Status: Recruiting
• Conditions: Sexual Risk Behavior; Substance Use Disorder (SUD); Sexual and Reproductive Health
• Intervention / Treatment: Behavioral: WORTH Paths Digital Intervention; Behavioral: WORTH Paths Wellness Group

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa N Slavin, PhD; Phone Number: 201-692-2301; Email: m.slavin@fdu.edu
• Study Contact Backup: Name: Annie J Rohan, PhD; Phone Number: 201-692-2840; Email: a.rohan@fdu.edu

Study Locations

• United States
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Recruiting
      • Fairleigh Dickinson University
      • Contact: Melissa N Slavin, PhD; Phone Number: 201-692-2301; Email: m.slavin@fdu.edu
      • Contact: Annie J Rohan, PhD; Phone Number: 201-692-2840

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WORTH Paths Digital Intervention Group; Participants will receive a culturally tailored program adapted for reproductive-aged women involved in the criminal legal system with substance use disorders and unmet contraceptive needs. The intervention consists of three facilitated group sessions over videoconference with digital interactive activities to support behavior change. Key components include: Raising awareness about different contraceptive methods and substance use treatment options; Discussing personal motivations for reducing drug use and using contraception; Developing skills to identify and manage substance use and reproductive health triggers; Digital interactive activities to reinforce learning and skill-building; Practicing decision-making tools and goal-setting strategies; Addressing barriers related to safety including intimate partner violence; Creating a safety plan and strategies for maintaining progress; Resources for state and online substance use and sexual/reproductive health services	Behavioral: WORTH Paths Digital Intervention; Participants in this arm will receive the WORTH Paths digital intervention, a culturally tailored program designed for women involved in the criminal legal system with substance use disorders and unmet contraceptive needs. The intervention consists of three facilitated group sessions over videoconference with digital interactive activities to support behavior change.
Active Comparator: WORTH Paths Digital Wellness Group; Participants in this arm will receive the WORTH Paths Wellness Group, a wellness-focused intervention delivered via three facilitated group sessions over videoconference with digital interactive activities. Sessions cover general health, stress reduction, and navigating health services. Topics include education about substance use and sexual and reproductive health risks, guided meditation and mindfulness training, stress management techniques, and an overview of substance use and reproductive health services. Participants will also receive digital wellness resources, including recorded mindfulness exercises and links to online platforms for health services.	Behavioral: WORTH Paths Wellness Group; A wellness-focused intervention consisting of three facilitated group sessions over videoconference with digital interactive activities. Sessions cover general health, stress reduction, and navigating health services, including education about substance use and sexual/reproductive health risks, guided meditation, stress management techniques, and an overview of available health services. Participants also receive digital wellness resources, including recorded mindfulness exercises and links to online health service platforms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Measurement 1: Treatment Completion Rates	Percentage of participants who complete all three intervention sessions, which occur once per week over a three-week period. Completion is defined as attending all sessions and engaging in digital interactive components.	Immediately after Session 3 (Week 3)
Feasibility Measurement 2: Session Completion Rates	Percentage of participants who complete each individual session. Completion is defined as attending the full session via videoconference and engaging with digital interactive activities.	Immediately after each session (Week 1, Week 2, Week 3)
Feasibility Measurement 3: Dropout Rates and Reasons for Termination	Proportion of participants who discontinue participation in the study. Participants who drop out will be asked to complete an exit survey detailing their reasons for withdrawal.	Immediately after each session (Week 1, Week 2, Week 3)
Feasibility Measurement 4: Technical Usability	Participants will report any technical difficulties they experienced during each session via a brief post-session survey. Measures include ease of use, ability to access materials, and time required to complete digital activities.	Immediately after each session (Week 1, Week 2, Week 3)
Feasibility Measurement 5: Qualitative Feasibility Assessment	Semi-structured qualitative interviews will be conducted to explore participant experiences related to feasibility. Participants will be asked about their ability to complete the intervention, challenges faced, technical usability, and factors influencing session engagement.	1 week after completion of Session 3 (Week 4)
Acceptability Measurement 1: Ease of Use	Participants will rate how easy it was to navigate the intervention, including videoconferencing and digital activities, using a Likert-scale survey (1-5). Mean scores will be calculated across sessions.	Immediately after each session (Week 1, Week 2, Week 3)
Acceptability Measurement 2: Helpfulness	Participants will assess how useful they found the intervention in supporting behavior change using a Likert-scale survey (1-5). Mean scores will be analyzed for trends across sessions.	Immediately after each session (Week 1, Week 2, Week 3)
Acceptability Measurement 3: Satisfaction	Overall satisfaction with the intervention will be measured through a Likert-scale survey (1-5), with mean scores reported across sessions.	Immediately after each session (Week 1, Week 2, Week 3)
Acceptability Measurement 4: Qualitative Acceptability Assessment	Semi-structured qualitative interviews will be conducted to explore participant experiences related to acceptability. Participants will be asked about ease of use, perceived helpfulness, satisfaction with the intervention, and suggestions for improvement.	1 week after completion of Session 3 (Week 4)
Change from baseline in self-reported primary illicit drug use at 3 months	Participants will report the number of days they used their primary illicit drug (the drug they identify as most problematic) in the past 30 days using the Timeline Followback (TLFB) method. Changes from baseline to 3-month follow-up will be analyzed.	Baseline and 3-month follow-up
Change from baseline in biologically confirmed illicit drug use at 3 months	Mail-in urine drug tests will be used to verify self-reported illicit drug use. Urine drug test kits will be mailed directly to participants' homes from Phamatech Lab and returned via mail directly to the lab. A positive drug test result will replace a negative self-report. Testing will screen for common substances, including opioids, cocaine, cannabis, and amphetamines.	Baseline and 3-month follow-up
Change from baseline in the number of participants initiating a contraceptive method highly effective at preventing unintended pregnancy at 3 months	Participants will report whether they have obtained a prescription or started using a contraceptive method considered highly effective at preventing unintended pregnancy, including an implant, intrauterine device (IUD), injection, birth control pill, patch, vaginal ring, or diaphragm. Change from baseline will be assessed.	Baseline and 3-month follow-up
Change from baseline in effective contraceptive use at 3 months	Participants will report the frequency and consistency of contraceptive use based on manufacturer guidelines. Measures will assess the proportion of sexual acts in which contraception was correctly used over the past 30 days.	Baseline and 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants linked to substance use treatment at 3 months	Linkage to treatment will be measured by the number of participants who report making an appointment for substance use disorder treatment and the number of sessions attended within the three-month follow-up period.	Baseline and 3-month follow-up

Collaborators and Investigators

• Sponsor: Fairleigh Dickinson University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Melissa N Slavin, PhD, Fairleigh Dickinson University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 9, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: substance use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Sexual Behavior; Substance-Related Disorders; Coitus
• Other Study ID Numbers: FDU-K01-2022-MNS; 5K01DA055762-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the sensitive nature of the data among a vulnerable population, as well as the small sample size (n=50), individual participant data (IPD) will not be shared. Participants are women involved in criminal legal systems with substance use histories, a vulnerable population facing heightened privacy risks. Even with de-identification, there is a concern about the potential for re-identification, particularly given the unique circumstances of participants and the detailed behavioral and health-related data (e.g., drug use) collected. Sharing this data could expose participants to unintended legal, social, or personal consequences. Given these ethical and confidentiality considerations, and in alignment with NIH's guidance on protecting sensitive data, IPD from this study will not be made available for external sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No