26 Clinical Trials for Various Conditions
This proposal will address financial wellbeing, an often overlooked but important factor impacting reentry for justice-involved people with mental health challenges, who are disproportionately Black and Latine. The project will change community level determinants by integrating financial capability support (one-on-one coaching and access to financial tools and services) into existing services and training bank and credit union staff to reduce discrimination. It will also support collaborative community efforts working towards upstream policy and legal reforms to reduce the incidence of those financial challenges.
The purpose of this study is to learn how to better support fathers and their families after incarceration. It will test an intervention that promotes healthy development for children of previously incarcerated fathers and the caregivers of their children for empirical promise through a pilot feasibility trial. The aims of the pilot are to demonstrate: a) client acceptance of the treatment (e.g., retention), b) ability to recruit sufficient numbers of participants, and c) feasibility of delivery with the clients and therapists in the designated treatment settings. About 15 families (15 fathers, 15 caregivers, and 15-20 children, totaling 45-50 participants) will be in the study.
The purpose of this study is to adapt an existing couples-level HIV prevention intervention for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and acceptability among men incarcerated in the Connecticut Department of Correction (CTDOC) and their community-dwelling committed female partners.
The investigators are conducting a randomized controlled trial to assess the impact of Resiliency in Stressful Experiences (RISE) - a comprehensive trauma-based program for young men releasing from a southeastern state's prisons. The investigators are assessing whether treating trauma and providing other transitional supports - such as employment assistance - as young men return home will help to improve their community stability and enhance their psychological well-being, in turn, resulting in less likelihood that a person will become incarcerated in the future.
TCN PATHS will recruit an anticipated 400 participants who are prescribed MOUD who are released from detention facilities. Each individual will be randomized to either 1) standard primary care (SPC) or 2) a Transitions Clinic Network (TCN) program primary care. Participants will be followed for a year and complete surveys at baseline and at month 1, 3, 6, 9, and 12. At each of these points research staff will confirm MOUD status. Urine drug screenings will be completed at baseline, month 1, 6, and 12 if the participant is not incarcerated. When possible, research staff will collect electronic health records.
The primary objective of the ROAR project is to evaluate an Oregon Department of Corrections (ODOC) pilot program that combines the use of extended-release naltrexone (XR-NTX) and Certified Recovery Mentors pre-release with linkage to community substance use disorder treatment to prevent fatal and non-fatal opioid overdoses among female adults released from prison.
HIV prevalence among incarcerated youth living with HIV (YWH) is three times that of the general population and one in seven of all persons with HIV experience incarceration each year. Furthermore, less than half of all youth in the United States with HIV achieve HIV viral load suppression, due to poor retention and adherence to anti-retroviral therapy (ART). Existing linkage and retention services are insufficient to meet the acute needs of youth with HIV who are at risk for incarceration, recently experienced incarceration or arrest, or those nearing reentry from a correctional facility. This holds particularly true in the high-need period following release from incarceration. The LINK2 study will develop and implement a youth service navigation (YSN) intervention to improve linkage and retention among YWH at risk for incarceration and with current incarceration and arrest histories and analyze results to address existing gaps in the literature. The investigators will enroll 142 YWH, aged 16-25 (+364 days), incarcerated in Los Angeles and Chicago jails and through community providers serving those at risk for incarceration and YWH with recent incarceration and arrest histories. The investigators will randomize participants to the YSN intervention (n=71) vs. a usual-care control group (n=71). The youth services navigators (YSNs) will assist with addressing immediate unmet needs such as housing, transportation, and food prior to clinical care and ongoing; will guide intervention participants to a range of community services to support progress along the continuum of HIV care; and will provide direct ART adherence support. The proposed study has two Primary Specific Aims: 1. Adapt an existing peer navigation intervention for adults to create a Youth Service Navigation (YSN) intervention sensitive to sexual and gender minority (SGM) culture that guides youth to needed services along the continuum of HIV care. This intervention combines medical, substance use and mental health care with comprehensive reentry support for YWH, aged 16-25 (+364 days) upon release from large county jails and juvenile detention systems or with arrests in the prior 12 months and those at risk for incarceration based on various social determinants. 2. Using a two-group RCT design, the investigators will test the effectiveness of the new YSN, youth SGM-sensitive intervention among YLWH aged 16-25 (+364 days), compared to controls offered standard of care. The investigators will evaluate the YSN Intervention's effect on post-incarceration linkage, retention, adherence, and viral suppression, as well as on substance use disorders, mental health, services utilization, and met needs. Secondary Aims: The investigators will assess YSN's effects on recidivism, costs and potential cost-offset/effectiveness.
A vicious cycle exists between adolescent substance use disorders and youth incarceration. Re-wiring adolescent social networks during community reentry after incarceration can potentially break the cycle of adolescent substance use and youth incarceration. Social networks influence adolescent substance use and delinquent behavior, yet little is known about how to intervene on social networks to improve health. Community reentry is a key opportunity to re-set youths' social networks and re-direct high-risk youth toward a healthier, more supportive network that can foster drug abstinence and reduce recidivism. The investigators hypothesize that an adult who has successfully navigated reentry can guide youth to rewire their social network by encouraging pro-social relationships, troubleshooting basic barriers to healthcare and social services, and helping create linkages to substance use and mental health treatment services. The goal of this study is to measure the impact of a pilot intervention to address two key barriers to accessing behavioral health treatment among recently incarcerated youth: poor care coordination and need for more positive support from the social network. The proposed study intervention, the Whole Person Care (WPC) Reentry Program, is based on the successful adult Transitions Clinic model, and is being adapted for delivery to transition age youth (TAY) by community partners in the Los Angeles County justice system. WPC community health workers (coaches) will provide recently released inmates a formerly incarcerated adult role model who provides care coordination and social support to facilitate access to needed health services, and who actively intervenes to guide TAY youth toward pro-social peers and adults. The investigators propose a pilot longitudinal study of WPC, using a community-partnered participatory research approach. The primary outcome will be reductions in adolescent substance use in response to the intervention (Aim 1). Secondary outcomes will test whether the intervention increases receipt of behavioral health services, decreases recidivism and mental health symptoms, and improves school and work engagement (Aim 2). Finally, the investigators will examine social networks as a potential mechanism by measuring whether youth receiving the intervention report healthier social networks (lower proportion of peers engaging in risky behaviors and a higher number of supportive adults) than control youth (Aim 3).
Veterans leaving incarceration and re-entering their communities (often described as "reentry" Veterans) face a number of challenges, including uncertainty about housing, vulnerability to substance use and relapse, on-going mental health concerns, and often multiple health conditions require timely continuity of care. The purpose of the project is to increase support for Veterans post-incarceration through the addition of trained peers with lived experience of being a Veteran and a history of incarceration. Emphasis will be on peers who will help link Veterans to Veterans Health Administration (VHA) services, including housing and healthcare. Peers will provide linkage with Health Care Reentry Veterans program specialists, transportation to appointments, and support in community reintegration. Peers will assist reentry veterans to make a successful transition and get and stay engaged in their care.
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study focuses on adults at the Rhode Island Department of Corrections who have active HCV and are awaiting trial. The study asks: * Can a simplified, low-barrier HCV treatment program work in a jail setting? * Do participants finish treatment and get cured using this approach? All participants will receive a 12-week course of the HCV medication sofosbuvir/velpatasvir (Epclusa). If they are released before completing treatment, they will take the remaining doses with them. Community Health Workers (CHWs) will help support participants after release, including reminding them to take medications and helping them get follow-up lab work. Researchers will measure: * Whether participants are cured of HCV * Whether the treatment approach is easy to use (feasible), acceptable, and followed correctly (fidelity) * Whether the program could be used in other jails or expanded in the future This study may help bring HCV treatment to more people in jail, reduce community spread of the virus, and support national goals to eliminate HCV.
The goal of this study is to measure the implementation and effectiveness of a multicomponent strategy for PrEP for people who are incarcerated at the Dallas County Jail. Specifically, based on a patients risk score on an electronic medical record HIV prediction model, referrals from providers and/or patient self-referrals, a PrEP patient navigator will meet with individuals at the jail to discuss HIV risk, offer HIV/STI testing if not yet completed and offer education around PrEP with referrals to community-based PrEP providers.
The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.
The investigators will conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education group (attention control) for prisoners high in self-reported anger dysregulation. The investigators will assess feasibility and acceptability of the yoga program, the health education control group, and research procedures.
This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail. The researchers will compare the utilization of HIV prevention and other support services between individuals who receive routine case management provided following enrollment to those who have access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support.
Smoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. People who are incarcerated represent the intersection of multiple high-priority populations (disproportionately African-American, Native American, low-income, homeless, on Medicaid, and suffering from mental illness and substance use disorders). This study examines the impact of a smoking cessation intervention for individuals discharged from jail to the community on smoking abstinence. Participants will be randomized to either 1) guideline-based, in-person smoking cessation counseling during incarceration, telephone counseling after incarceration, and nicotine replacement, or 2) enhanced treatment as usual. This study's findings will be used to develop a larger, multi-site study that is fully powered to measure longer-term health and smoking cessation outcomes.
The overall objective of this study is to evaluate an educational overdose prevention intervention's effectiveness among incarcerated people living with HIV/AIDS, specifically within the context of other outcomes related to health and experiences after incarceration. Results will be used to develop tailored interventions to reduce overdose deaths among high-risk correctional populations. The research has the following aims: * Aim 1: Evaluate a pilot program to provide HIV+ inmates with 1:1 overdose prevention training while incarcerated; * Aim 2: Identify the criminal justice, health, and HIV-related factors associated with overdose risk; and * Aim 3: Describe the overdose risk experiences of HIV+ former inmates who use opioids after release.
64,000 Veterans are released annually from jails and prisons. These Veterans have a weekly unemployment rate of up to 40-55%. However, many are unable to access traditional vocational rehabilitation, not to mention specialized vocational rehabilitation for those with felony histories. Distance learning may be effective in improving access to rehabilitation as well as improving employment outcomes. The Compass system was developed to incorporate both synchronous and asynchronous distance learning to provide effective services. This study will evaluate 150 Veterans with histories of legal convictions and mental illness and/or a substance use disorder. Veterans will be randomly assigned to either a basic vocational resources condition or the the Compass condition. In the basic condition, Veterans will be provided with basic information about where they can access vocational services and a paper version of a vocational reintegration manual, specifically the About Face Vocational Manual. Veterans assigned to the Compass condition will be given access to the online instruction through Videos, live chat features, and tele-health practice interviews with feedback. Veterans will be followed for 6 months. The primary outcomes are employment and interview skills.
The goal of this study is to test whether peer mentors (i.e., individuals with past opioid addiction and prior incarceration) can facilitate entrance into buprenorphine (Suboxone) treatment for individuals with opioid use disorder who were recently released from jail or prison. In order to test whether it is helpful to have peer mentors paired with recently released individuals, the investigators will conduct an 18 month study, recruiting 72 formerly incarcerated individuals and assigning them by chance selection (like flipping a coin) to either a group that will receive peer mentorship or a group that will receive a referral to a community clinic.
The aim of this trial is to assess the clinical utility, effectiveness, and cost implications of treatment for incarcerated offenders with opioid use disorders who are randomly assigned to one of three treatment conditions to include a depot formulation of naltrexone (XR-NTX, as Vivitrol®) only (XR-NTX), Vivitrol provided with sessions with a patient navigator (PN) XR-NTX+PN, and a drug education procedure (ETAU) before being released to the community. This trial will investigate whether effective medication therapy used in non-incarcerated populations will also be effective in incarcerated individuals. Empirical evidence demonstrates that starting treatment before release greatly increases the probability of successful outcome including reduced alcohol and drug use, increased employment rates, and reduced recidivism rates.
The goal of this study is to determine whether a culturally congruent, group intervention can reduce HIV risk behaviors among recently incarcerated, bisexual, African American men.
The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft, Oklahoma. The purpose of the proposed study is to expand previous findings by including a comparison group of women that are not receiving treatment but are otherwise eligible, and by using outside evaluators to conduct the assessments. Furthermore, this study will extend the outcomes measured in previous evaluations by including measures of sleep disturbance, posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The hypotheses for this study are listed below: 1. Incarcerated women with substance use disorders and history of trauma enrolled in the integrated treatment program (HWR plus BT) will report significantly fewer symptoms on measures of posttraumatic stress and associated cognitions, substance use, depression, and related symptoms following treatment than those in the comparison group. 2. Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.
The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.
The goal of the study is to evaluate the efficacy of a two therapeutic models designed to enhance women's skills for managing reactive emotions in their current lives as well as to educate them about how using these skills can enhance their personal effectiveness and help them to gain control of post-traumatic stress reactions. The interventions adaptations of a manualized psychotherapy that has shown promise with adults with complex Posttraumatic Stress Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET) compared to a supportive group therapy (SGT) that has been found to have modest benefits with women survivors of childhood abuse (Wallis, 2002).
The phase I evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by California parolees assigned to the study group.
The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use.