WORTH Paths Intervention

NCT06889831 | Recruiting

• 2 other identifiers: FDU-K01-2022-MNS5K01DA055762-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

substance use disorder

Outcome Measures

Primary Outcomes (13)

• Feasibility Measurement 1: Treatment Completion Rates

  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.

  Immediately after Session 3 (Week 3)

• Feasibility Measurement 2: Session Completion Rates

  Percentage of participants who complete each individual session. Completion is defined as attending the full session via videoconference and engaging with digital interactive activities.

  Immediately after each session (Week 1, Week 2, Week 3)

• Feasibility Measurement 3: Dropout Rates and Reasons for Termination

  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.

  Immediately after each session (Week 1, Week 2, Week 3)

• Feasibility Measurement 4: Technical Usability

  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.

  Immediately after each session (Week 1, Week 2, Week 3)

• Feasibility Measurement 5: Qualitative Feasibility Assessment

  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.

  1 week after completion of Session 3 (Week 4)

• Acceptability Measurement 1: Ease of Use

  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.

  Immediately after each session (Week 1, Week 2, Week 3)

• Acceptability Measurement 2: Helpfulness

  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.

  Immediately after each session (Week 1, Week 2, Week 3)

• Acceptability Measurement 3: Satisfaction

  Overall satisfaction with the intervention will be measured through a Likert-scale survey (1-5), with mean scores reported across sessions.

  Immediately after each session (Week 1, Week 2, Week 3)

• Acceptability Measurement 4: Qualitative Acceptability Assessment

  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.

  1 week after completion of Session 3 (Week 4)

• Change from baseline in self-reported primary illicit drug use at 3 months

  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.

  Baseline and 3-month follow-up

• Change from baseline in biologically confirmed illicit drug use at 3 months

  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.

  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

  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.

  Baseline and 3-month follow-up

• Change from baseline in effective contraceptive use at 3 months

  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.

  Baseline and 3-month follow-up

Secondary Outcomes (1)

• Number of participants linked to substance use treatment at 3 months

  Baseline and 3-month follow-up

Study Arms (2)

WORTH Paths Digital Intervention Group

EXPERIMENTAL

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

Behavioral: WORTH Paths Digital Intervention

WORTH Paths Digital Wellness Group

ACTIVE COMPARATOR

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.

Behavioral: WORTH Paths Wellness Group

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 Digital Intervention Group

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.

WORTH Paths Digital Wellness Group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Participants who identify as women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fairleigh Dickinson University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Fairleigh Dickinson University

Teaneck, New Jersey, 07666, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Coitus

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Sexual Behavior; Behavior

Study Officials

• Melissa N Slavin, PhD

  Fairleigh Dickinson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa N Slavin, PhD

CONTACT

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

Annie J Rohan, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: N/A (No masking in this study)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel Assignment - Participants will be randomly assigned to one of two groups: * Intervention Group: Receives a digital intervention including facilitated group-based treatment via videoconference and interactive activities to reduce substance use and improve contraceptive use. * Control Group: Receives a wellness intervention focusing on stress reduction, physical activity, and general health. This is a pilot randomized controlled trial. The study will recruit 50 reproductive-aged women involved in criminal legal systems with substance use disorders and unmet need for contraception who will be randomly assigned to either the intervention (n=25) or the wellness control condition (n=25). Both arms involve facilitated group-based treatment via videoconference.

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 21, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)