Substance Use Disorder (SUD)NCT06889831
WORTH Paths Intervention
A study testing WORTH Paths Digital Intervention and WORTH Paths Wellness Group in people with Substance Use Disorder (SUD) and Sexual and Reproductive Health, run by Fairleigh Dickinson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Substance Use Disorder (SUD), Sexual and Reproductive Health, Sexual Risk Behavior
- What is being tested?
- WORTH Paths Digital Intervention and WORTH Paths Wellness Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fairleigh Dickinson University
Teaneck, New Jersey, 07666
Melissa N Slavin, PhD, 201-692-2301, m.slavin@fdu.edu
Annie J Rohan, PhD, 201-692-2840
About this study
Official title: Adaptation of a Digital Group-Based Intervention to Reduce Drug Use and Increase Contraceptive Use Among Reproductive-Aged Women Involved in Criminal Justice Systems
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.
Read more
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).
Read the detailed description
Many women involved in the criminal legal system experience substance use disorders and unintended pregnancy but face significant barriers to accessing and utilizing substance use treatment and sexual and reproductive health services. These barriers include limited social support, intimate partner violence, and challenges with self-advocacy and decision-making regarding substance use treatment and contraception. The siloed nature of healthcare services also makes it difficult for women to receive integrated care that addresses both substance use and sexual and reproductive health needs.
While some existing programs for women in the criminal legal system focus on HIV prevention through condom use, fewer interventions take a comprehensive approach to sexual and reproductive health by addressing all forms of contraception while also integrating substance use treatment strategies.
This study tests WORTH Paths, a digital intervention designed to reduce drug use and increase contraceptive use. WORTH Paths builds on Women on the Road to Health (WORTH), an evidence-based CDC Best Practice HIV prevention intervention originally developed at the Columbia University School of Social Work. While WORTH has been effective in increasing condom use, this new adaptation expands its focus to a broader range of contraceptive methods and strategies to support women in reducing drug use.
Study Design
This study is a randomized controlled trial (RCT). Participants will be randomly assigned to one of two groups:
- WORTH Paths Intervention Group Participants in this group will receive the WORTH Paths program, a culturally tailored digital intervention designed to help women involved in the criminal legal system reduce substance use and improve contraceptive use. This intervention includes:
- Three virtual group sessions led by trained facilitators via videoconferencing
- Culturally relevant digital interactive activities, including animations, videos, and exercises to reinforce key skills
- Education on a full range of contraceptive methods, including long-acting reversible contraception (LARC), barrier methods, and other effective forms of contraception at reducing unintended pregnancy and sexually transmitted infections
- Guidance on accessing and navigating substance use treatment and reproductive healthcare services, including how to advocate for their needs within the healthcare system
- Cognitive-behavioral and motivational interviewing (MI)-based activities to help participants develop personalized strategies for reducing substance use and improving reproductive health behaviors
- Skill-building for self-regulation and behavioral strategies, including managing drug-related triggers, coping with relationship and environmental stressors, and setting personal health goals
- Safety planning and decision-making strategies, with a focus on reducing interpersonal risks such as intimate partner violence and reproductive coercion
- Participants in the intervention group will also receive resources for substance use treatment and sexual and reproductive health services, including referrals to local and online providers for contraception and substance use treatment.
- Control Group (Wellness Program)
Participants in the control group will receive a general wellness program designed to provide support and education while excluding the behavioral skill-building components of the intervention. This program includes:
- Three virtual group sessions led by trained facilitators via videoconferencing
- Education about challenges in accessing substance use treatment and sexual and reproductive health services among women in the criminal legal system
- Guided mindfulness exercises, including meditation and relaxation techniques
- Stress management strategies, such as breathing exercises and coping mechanisms for managing emotional distress
- General wellness discussions on self-care and maintaining overall well-being
- Referrals and informational resources for substance use treatment and reproductive health services, but no structured training on how to navigate or advocate for care Unlike the intervention group, the control group will not receive training in behavioral change strategies related to substance use or contraceptive use.
Assessments \& Data Collection
All participants will complete:
- Baseline assessments and mail-in urine drug tests at enrollment
- Follow-up assessments and mail-in urine drug tests at 3 months
- Participants will report on drug use and contraceptive use through online surveys. Urine samples will biologically verify changes in drug use.
Eligibility Criteria
To participate, individuals must:
- Identify as a woman aged 18-44
- Have had criminal legal system involvement within the past year
- Meet DSM-5 criteria for current illicit substance use disorder as assessed by the Mini International Neuropsychiatric Interview (MINI)
- Have a past 30-day history of unmet need for contraception (not using contraception despite not wanting to become pregnant)
- Live in the New York metropolitan area (New York, New Jersey, or Connecticut)
Exclusion Criteria:
- Unable to give informed consent due to a medical condition or cognitive impairment
- Does not speak, read, or write in English
- Unwilling to follow study procedures Recruitment Methods
- Participants will be recruited through community-based organizations that serve formerly incarcerated women. Recruitment efforts will include:
Flyers and posters at community centers and shelters
- Announcements on community listservs
- Direct referrals from program staff
- Participation is completely voluntary, and participants may withdraw at any time. Privacy will be strictly protected.
Data Collection \& Safety Measures The study will use self-reported surveys and urine drug tests to measure changes in substance use.
Surveys will be completed securely online
- Data will be stored in a password-protected, encrypted system to ensure confidentiality
- Trained facilitators will monitor sessions and provide referrals if needed. If a participant experiences distress, they will be connected to counseling and substance use treatment resources.
Potential Benefits
While there is no guaranteed benefit, participants may:
- Gain new knowledge about contraception and reproductive health
- Receive support and strategies for reducing drug use and improving contraceptive use
- Obtain referrals for substance use treatment and sexual/reproductive health services (local and online)
- Improve self-efficacy and decision-making skills
- Being tested
- WORTH Paths Digital Intervention, WORTH Paths Wellness Group
- Keywords
- substance use disorder
- Medical subject headings
- Substance-Related Disorders, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WORTH Paths Digital InterventionBehavioural
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 GroupBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: WORTH Paths Wellness Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3-month follow-up
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.
Measured: Baseline and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start12 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fairleigh Dickinson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Melissa Slavin, Fairleigh Dickinson University
- Investigators
- Melissa N Slavin, PhD, Principal investigator, Fairleigh Dickinson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889831
- Sponsor's protocol ID
- FDU-K01-2022-MNS
- Other IDs
- 5K01DA055762-04
- Status last verified
- May 2026
- First submitted
- 9 Mar 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitive nature of the data among a vulnerable population, as well as the small sample size (n=50), individual participant data (IPD) will not be shared. Participants are women involved in criminal legal systems with substance use histories, a vulnerable population facing heightened privacy risks. Even with de-identification, there is a concern about the potential for re-identification, particularly given the unique circumstances of participants and the detailed behavioral and health-related data (e.g., drug use) collected. Sharing this data could expose participants to unintended legal, social, or personal consequences. Given these ethical and confidentiality considerations, and in alignment with NIH's guidance on protecting sensitive data, IPD from this study will not be made available for external sharing.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a Digital Group-Based Intervention to Reduce Drug Use and Increase Contraceptive Use Among Reproductive-Aged Women Involved in Criminal Justice Systems
- ClinicalTrials.gov ID
- NCT06889831
- Acronym / sponsor ID
- FDU-K01-2022-MNS
- Keywords
- substance use disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fairleigh Dickinson UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Many women involved in the criminal legal system experience substance use disorders and unintended pregnancy but face significant barriers to accessing and utilizing substance use treatment and sexual and reproductive health services. These barriers include limited social support, intimate partner violence, and challenges with self-advocacy and decision-making regarding substance use treatment and contraception. The siloed nature of healthcare services also makes it difficult for women to receive integrated care that addresses both substance use and sexual and reproductive health needs.
While some existing programs for women in the criminal legal system focus on HIV prevention through condom use, fewer interventions take a comprehensive approach to sexual and reproductive health by addressing all forms of contraception while also integrating substance use treatment strategies.
This study tests WORTH Paths, a digital intervention designed to reduce drug use and increase contraceptive use. WORTH Paths builds on Women on the Road to Health (WORTH), an evidence-based CDC Best Practice HIV prevention intervention originally developed at the Columbia University School of Social Work. While WORTH has been effective in increasing condom use, this new adaptation expands its focus to a broader range of contraceptive methods and strategies to support women in reducing drug use.
Study Design
This study is a randomized controlled trial (RCT). Participants will be randomly assigned to one of two groups:
- WORTH Paths Intervention Group Participants in this group will receive the WORTH Paths program, a culturally tailored digital intervention designed to help women involved in the criminal legal system reduce substance use and improve contraceptive use. This intervention includes:
- Three virtual group sessions led by trained facilitators via videoconferencing
- Culturally relevant digital interactive activities, including animations, videos, and exercises to reinforce key skills
- Education on a full range of contraceptive methods, including long-acting reversible contraception (LARC), barrier methods, and other effective forms of contraception at reducing unintended pregnancy and sexually transmitted infections
- Guidance on accessing and navigating substance use treatment and reproductive healthcare services, including how to advocate for their needs within the healthcare system
- Cognitive-behavioral and motivational interviewing (MI)-based activities to help participants develop personalized strategies for reducing substance use and improving reproductive health behaviors
- Skill-building for self-regulation and behavioral strategies, including managing drug-related triggers, coping with relationship and environmental stressors, and setting personal health goals
- Safety planning and decision-making strategies, with a focus on reducing interpersonal risks such as intimate partner violence and reproductive coercion
- Participants in the intervention group will also receive resources for substance use treatment and sexual and reproductive health services, including referrals to local and online providers for contraception and substance use treatment.
- Control Group (Wellness Program)
Participants in the control group will receive a general wellness program designed to provide support and education while excluding the behavioral skill-building components of the intervention. This program includes:
- Three virtual group sessions led by trained facilitators via videoconferencing
- Education about challenges in accessing substance use treatment and sexual and reproductive health services among women in the criminal legal system
- Guided mindfulness exercises, including meditation and relaxation techniques
- Stress management strategies, such as breathing exercises and coping mechanisms for managing emotional distress
- General wellness discussions on self-care and maintaining overall well-being
- Referrals and informational resources for substance use treatment and reproductive health services, but no structured training on how to navigate or advocate for care Unlike the intervention group, the control group will not receive training in behavioral change strategies related to substance use or contraceptive use.
Assessments \& Data Collection
All participants will complete:
- Baseline assessments and mail-in urine drug tests at enrollment
- Follow-up assessments and mail-in urine drug tests at 3 months
- Participants will report on drug use and contraceptive use through online surveys. Urine samples will biologically verify changes in drug use.
Eligibility Criteria
To participate, individuals must:
- Identify as a woman aged 18-44
- Have had criminal legal system involvement within the past year
- Meet DSM-5 criteria for current illicit substance use disorder as assessed by the Mini International Neuropsychiatric Interview (MINI)
- Have a past 30-day history of unmet need for contraception (not using contraception despite not wanting to become pregnant)
- Live in the New York metropolitan area (New York, New Jersey, or Connecticut)
Exclusion Criteria:
- Unable to give informed consent due to a medical condition or cognitive impairment
- Does not speak, read, or write in English
- Unwilling to follow study procedures Recruitment Methods
- Participants will be recruited through community-based organizations that serve formerly incarcerated women. Recruitment efforts will include:
Flyers and posters at community centers and shelters
- Announcements on community listservs
- Direct referrals from program staff
- Participation is completely voluntary, and participants may withdraw at any time. Privacy will be strictly protected.
Data Collection \& Safety Measures The study will use self-reported surveys and urine drug tests to measure changes in substance use.
Surveys will be completed securely online
- Data will be stored in a password-protected, encrypted system to ensure confidentiality
- Trained facilitators will monitor sessions and provide referrals if needed. If a participant experiences distress, they will be connected to counseling and substance use treatment resources.
Potential Benefits
While there is no guaranteed benefit, participants may:
- Gain new knowledge about contraception and reproductive health
- Receive support and strategies for reducing drug use and improving contraceptive use
- Obtain referrals for substance use treatment and sexual/reproductive health services (local and online)
- Improve self-efficacy and decision-making skills
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| WORTH Paths Digital Intervention Group | Experimental | Behavioral: WORTH Paths Digital InterventionParticipants 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 |
| WORTH Paths Digital Wellness Group | Active comparator | Behavioral: WORTH Paths Wellness GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WORTH Paths Digital InterventionParticipants 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. | Behavioural | WORTH Paths Digital Intervention Group |
| WORTH Paths Wellness GroupA 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. | Behavioural | WORTH Paths Digital Wellness Group |
Primary outcome
Feasibility Measurement 1: Treatment Completion Rates
Time frame: Immediately after Session 3 (Week 3)
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.
Feasibility Measurement 2: Session Completion Rates
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
Percentage of participants who complete each individual session. Completion is defined as attending the full session via videoconference and engaging with digital interactive activities.
Feasibility Measurement 3: Dropout Rates and Reasons for Termination
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
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.
Feasibility Measurement 4: Technical Usability
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
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.
Feasibility Measurement 5: Qualitative Feasibility Assessment
Time frame: 1 week after completion of Session 3 (Week 4)
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.
Acceptability Measurement 1: Ease of Use
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
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.
Acceptability Measurement 2: Helpfulness
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
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.
Acceptability Measurement 3: Satisfaction
Time frame: Immediately after each session (Week 1, Week 2, Week 3)
Overall satisfaction with the intervention will be measured through a Likert-scale survey (1-5), with mean scores reported across sessions.
Acceptability Measurement 4: Qualitative Acceptability Assessment
Time frame: 1 week after completion of Session 3 (Week 4)
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.
Change from baseline in self-reported primary illicit drug use at 3 months
Time frame: Baseline and 3-month follow-up
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.
Change from baseline in biologically confirmed illicit drug use at 3 months
Time frame: Baseline and 3-month follow-up
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.
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
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.
Change from baseline in effective contraceptive use at 3 months
Time frame: Baseline and 3-month follow-up
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.
1 secondary outcome
Number of participants linked to substance use treatment at 3 months
Time frame: Baseline and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. Due to the sensitive nature of the data among a vulnerable population, as well as the small sample size (n=50), individual participant data (IPD) will not be shared. Participants are women involved in criminal legal systems with substance use histories, a vulnerable population facing heightened privacy risks. Even with de-identification, there is a concern about the potential for re-identification, particularly given the unique circumstances of participants and the detailed behavioral and health-related data (e.g., drug use) collected. Sharing this data could expose participants to unintended legal, social, or personal consequences. Given these ethical and confidentiality considerations, and in alignment with NIH's guidance on protecting sensitive data, IPD from this study will not be made available for external sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa N Slavin, PhD principal investigator
Fairleigh Dickinson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WORTH Paths Digital Intervention and WORTH Paths Wellness Group in people with Substance Use Disorder (SUD) and Sexual and Reproductive Health, run by Fairleigh Dickinson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa N Slavin, PhD (201-692-2301, m.slavin@fdu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Measurement 1: Treatment Completion Rates (time frame: Immediately after Session 3 (Week 3)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.