Background Persons involved in the justice system are at high risk for HIV and drug overdose upon release to the community. This manuscript describes a randomized controlled trial of two evidence-based linkage interventions for provision of HIV prevention and treatment and substance use disorder (SUD) services in four high risk communities to assess which is more effective at addressing these needs upon reentry to the community from the justice system. Methods This is a 5-year hybrid type 1 effectiveness-implementation randomized controlled trial that compares two models (Patient Navigation [PN] or Mobile Health Unit [MHU] service delivery) of linking justice-involved individuals to the continuum of community-based HIV and SUD prevention and treatment service cascades of care. A total of 864 justice-involved individuals in four US communities with pre-arrest histories of opioid and/or stimulant use who are living with or at-risk of HIV will be randomized to receive either: (a) PN, wherein patient navigators will link study participants to community-based service providers; or (b) services delivered via an MHU, wherein study participants will be provided integrated HIV prevention/ treatment services and SUD services. The six-month post-release intervention will focus on access to pre-exposure prophylaxis (PrEP) for those without HIV and antiretroviral treatment (ART) for people living with HIV (PLH). Secondary outcomes will examine the continuum of PrEP and HIV care, including: HIV viral load, PrEP/ ART adherence; HIV risk behaviors; HCV testing and linkage to treatment; and sexually transmitted infection incidence and treatment. Additionally, opioid and other substance use disorder diagnoses, prescription, receipt, and retention on medication for opioid use disorder; opioid and stimulant use; and overdose will also be assessed. Primary implementation outcomes include feasibility, acceptability, sustainability, and costs required to implement and sustain the approaches as well as to scale-up in additional communities. Discussion Results from this project will help inform future methods of delivery of prevention, testing, and treatment of HIV, HCV, substance use disorders (particularly for opioids and stimulants), and sexually transmitted infections for justice-involved individuals in the community. Trial registration: Clincialtrials.gov NCT05286879 March 18, 2022.

Background Worldwide, the United States has the highest incarceration rate per capita. Thousands of people are released from US correctional facilities each year, including many who are impacted by HIV infection and substance use disorder (SUD), two frequently comorbid conditions that present multiple challenges upon reentry. Reentry and care engagement research involving justice-involved people with HIV (PWH) with comorbid SUD has been largely limited to the perspective of those released. To formulate effective interventions for this population aimed at maintaining health and reducing recidivism, it is crucial to collect data from formerly incarcerated individuals with firsthand experience of the reentry process as well as other actors within the reentry framework. Insights from medical and legal service providers working in reentry systems have the potential to address key implementation concerns. To inform an intervention aimed at helping recently-released individuals PWH and SUD, we conducted a qualitative study to assess barriers and facilitators to community reentry from the perspectives of diverse consumers and providers of medical, legal, and reentry services. Results Fifteen stakeholders within XXX County participated in in-person interviews. Results indicated that 1) Patients/clients emphasized psychosocial support and individual attitude more than medical and legal participants, who chiefly focused on logistical factors such as finances, housing, and transportation; 2) Patients/clients expressed both medical and legal needs during the reentry period, though medical providers and participants from legal entities mainly expressed concerns limited to their respective scopes of work; 3) All three participant groups underscored the need for a low-barrier, collaborative, patient-centered approach to reentry with the goal of achieving self-sufficiency. Conclusions Findings support and extend existing literature detailing the barriers and facilitators to successful reentry. Our findings underscore the notion that an effective reentry intervention addresses both medical and legal needs, includes an individualized approach that incorporates psychosocial needs, and focuses on establishing self-sufficiency.

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