Recruiting

WORTH Paths

Sponsor:

Fairleigh Dickinson University

Code:

NCT06889831

Conditions

Substance Use Disorder (SUD)

Sexual and Reproductive Health

Sexual Risk Behavior

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

WORTH Paths Digital Intervention

WORTH Paths Wellness Group

Study Details

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).

Conditions

Substance Use Disorder (SUD)

Sexual and Reproductive Health

Sexual Risk Behavior

Study ID

NCT06889831

Start date

Aug 12, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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 measure

  • Feasibility Measurement 1: Treatment Completion Rates [ Time Frame: Immediately after Session 3 (Week 3) ]
  • Feasibility Measurement 2: Session Completion Rates [ Time Frame: Immediately after each session (Week 1, Week 2, Week 3) ]
  • Feasibility Measurement 3: Dropout Rates and Reasons for Termination [ Time Frame: Immediately after each session (Week 1, Week 2, Week 3) ]
  • Feasibility Measurement 4: Technical Usability [ Time Frame: Immediately after each session (Week 1, Week 2, Week 3) ]
  • Feasibility Measurement 5: Qualitative Feasibility Assessment [ Time Frame: 1 week after completion of Session 3 (Week 4) ]
  • Acceptability Measurement 1: Ease of Use [ Time Frame: Immediately after each session (Week 1, Week 2, Week 3) ]
  • Acceptability Measurement 2: Helpfulness [ Time Frame: Immediately after each session (Week 1, Week 2, Week 3) ]
  • Acceptability Measurement 3: Satisfaction [ Time Frame: Immediately after each session (Week 1, Week 2, Week 3) ]
  • Acceptability Measurement 4: Qualitative Acceptability Assessment [ Time Frame: 1 week after completion of Session 3 (Week 4) ]
  • Change from baseline in self-reported primary illicit drug use at 3 months [ Time Frame: Baseline and 3-month follow-up ]
  • Change from baseline in biologically confirmed illicit drug use at 3 months [ Time Frame: 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 [ Time Frame: Baseline and 3-month follow-up ]
  • Change from baseline in effective contraceptive use at 3 months [ Time Frame: Baseline and 3-month follow-up ]

Central Contacts and Locations

Central contacts

Melissa N Slavin, PhD

201-692-2301m.slavin@fdu.edu

Annie J Rohan, PhD

201-692-2840a.rohan@fdu.edu

Locations

Fairleigh Dickinson University

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Melissa N Slavin, PhD

201-692-2301m.slavin@fdu.edu

Annie J Rohan, PhD

201-692-2840

More Information

Sponsor

Fairleigh Dickinson University

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • substance use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fairleigh Dickinson University on 2026-05-06.