Adaptation of a Digital Group-Based Intervention to Reduce Drug Use and Increase Contraceptive Use Among Reproductive-Aged Women Involved in Criminal Justice Systems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility Measurement 1: Treatment Completion Rates
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
N/A (No masking in this study)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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
干预措施: WORTH Paths Digital Intervention (Behavioral)
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.
干预措施: WORTH Paths Wellness Group (Behavioral)
结局指标
主要结局
Feasibility Measurement 1: Treatment Completion Rates
时间窗: 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
时间窗: 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.
Acceptability Measurement 3: Satisfaction
时间窗: 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.
Feasibility Measurement 3: Dropout Rates and Reasons for Termination
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 4: Qualitative Acceptability Assessment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Number of participants linked to substance use treatment at 3 months(Baseline and 3-month follow-up)
研究者
Melissa Slavin
Assistant Professor
Fairleigh Dickinson University