| NCT ID | NCT06889831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fairleigh Dickinson University |
| Condition | Substance Use Disorder (SUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-08-12 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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)
Contact & Investigator
Melissa N Slavin, PhD
PRINCIPAL INVESTIGATOR
Fairleigh Dickinson University
Frequently Asked Questions
Who can join the NCT06889831 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 44 Years, studying Substance Use Disorder (SUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06889831 currently recruiting?
Yes, NCT06889831 is actively recruiting participants. Contact the research team at m.slavin@fdu.edu for enrollment information.
Where is the NCT06889831 trial being conducted?
This trial is being conducted at Teaneck, United States.
Who is sponsoring the NCT06889831 clinical trial?
NCT06889831 is sponsored by Fairleigh Dickinson University. The principal investigator is Melissa N Slavin, PhD at Fairleigh Dickinson University. The trial plans to enroll 50 participants.