WORTH Paths Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorFairleigh Dickinson University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
WORTH Paths Digital Intervention
BehavioralParticipants 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
BehavioralA 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: WORTH Paths Digital Intervention GroupExperimental treatment 1 intervention
Group B: WORTH Paths Digital Wellness GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately after Session 3 (Week 3)2
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.
Time frame
Immediately after each session (Week 1, Week 2, Week 3)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.
Time frame
Immediately after each session (Week 1, Week 2, Week 3)4
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.
Time frame
Immediately after each session (Week 1, Week 2, Week 3)Secondary outcomes
1
Number of participants linked to substance use treatment at 3 months
Linkage to treatment will be measured by the number of participants who report making an appointment for substance use disorder treatment and the number of sessions attended within the three-month follow-up period.
Time frame
Baseline and 3-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fairleigh Dickinson University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov