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).
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
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