WORTH Paths Intervention

Part of paid clinical trials in Teaneck, New Jersey.

Sponsor
Fairleigh Dickinson University
Study ID
NCT06889831
Status
Recruiting
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Conditions

  • Sexual Risk Behavior
  • Sexual and Reproductive Health
  • Substance Use Disorder (SUD)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • WORTH Paths Digital Intervention — BEHAVIORAL
    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.
  • WORTH Paths Wellness Group — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Aug 12, 2025
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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
  • 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.

Primary Outcome Measure

Feasibility Measurement 1: Treatment Completion Rates [ Time Frame: Immediately after Session 3 (Week 3) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fairleigh Dickinson UniversityTeaneckNew Jersey07666
Melissa N Slavin, PhD
[email protected]
201-692-2301
Annie J Rohan, PhD
201-692-2840

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