NCT06889831 · Fairleigh Dickinson University
WORTH Paths Intervention
What this study is about
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.
View original scientific description
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).
Interventions
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.
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.
Primary outcome measures
Feasibility Measurement 1: Treatment Completion Rates
Time frame: Immediately after Session 3 (Week 3)
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.
Feasibility Measurement 2: Session Completion Rates
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
Percentage of participants who complete each individual session. Completion is defined as attending the full session via videoconference and engaging with digital interactive activities.
Feasibility Measurement 3: Dropout Rates and Reasons for Termination
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
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.
Feasibility Measurement 4: Technical Usability
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
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.
Feasibility Measurement 5: Qualitative Feasibility Assessment
Time frame: 1 week after completion of Session 3 (Week 4)
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.
Acceptability Measurement 1: Ease of Use
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
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.
Acceptability Measurement 2: Helpfulness
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
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.
Acceptability Measurement 3: Satisfaction
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
Overall satisfaction with the intervention will be measured through a Likert-scale survey (1-5), with mean scores reported across sessions.
Acceptability Measurement 4: Qualitative Acceptability Assessment
Time frame: 1 week after completion of Session 3 (Week 4)
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.
Change from baseline in self-reported primary illicit drug use at 3 months
Time frame: Baseline and 3-month follow-up
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.
Change from baseline in biologically confirmed illicit drug use at 3 months
Time frame: Baseline and 3-month follow-up
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.
Change from baseline in the number of participants initiating a contraceptive method highly effective at preventing unintended pregnancy at 3 months
Time frame: Baseline and 3-month follow-up
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.
Change from baseline in effective contraceptive use at 3 months
Time frame: Baseline and 3-month follow-up
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Teaneck, New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations