Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons.

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.

Factors associated with retention on medications for opioid use disorder among a cohort of adults seeking treatment in the community.

BACKGROUND: Medication treatment for opioid use disorder (OUD) (MOUD; buprenorphine and methadone) reduces opioid use and overdose. Discontinuation of MOUD can quickly lead to relapse, overdose and death. Few persons who initiate MOUD are retained on treatment, thus it is critical to identify factors associated with retention. METHODS: Evaluated data was from an ongoing prospective cohort study of adults aged 18 or older with DSM-5 moderate to severe OUD seeking MOUD in the community and followed for 6 months. Participants were considered retained on MOUD through 6 months if they reported taking MOUD at every study interview without discontinuation. A high dose of MOUD was defined as a methadone dose > 85 mg or buprenorphine dose ≥ 16 mg. Multivariable logistic regression was conducted to assess factors associated with 6-month MOUD retention. RESULTS: A total of 118 participants (73% male, 58% white, 36% with HIV) were included. Buprenorphine was initiated by 58% and 42% started methadone. MOUD retention was 49% and 58% among buprenorphine and methadone, respectively, at 6-months. In adjusted models, a high MOUD dose (OR = 4.71, 95% CI 2.05-10.84) and higher pain interference (OR = 1.59, 95% CI 1.15-2.19) was associated with MOUD retention. CONCLUSIONS: Adequate dosing of MOUD leads to improved retention on MOUD. Further, persons with high pain interference at baseline had higher odds of retention on MOUD. Both methadone and buprenorphine have analgesic effects, thus those with high pain interference could have dual benefits of MOUD for treating OUD and pain. Interventions should be tailored to improve adequate MOUD dosing to improve retention on MOUD.

Linking criminal justice-involved individuals to HIV, Hepatitis C, and opioid use disorder prevention and treatment services upon release to the community: Progress, gaps, and future directions.

Improving HIV and Hepatitis C Virus (HCV) management among people involved in the criminal justice (CJ) system who use drugs, in particular those with opioid use disorder (OUD), requires effective approaches to screening, linkage, and adherence to integrated prevention and treatment services across correctional and community agencies and providers. This manuscript reviews the literature to explore gaps in HIV, Hepatitis C, and OUD prevention, treatment, and delivery cascades of care for persons involved in the CJ system. Specifically, we compare two models of linkage to prevention and treatment services: Peer/Patient Navigation (PN) wherein the PN links CJ-involved individuals to community-based infectious disease (ID) and substance use prevention and treatment services, and Mobile Health Units (MHU) wherein individuals are linked to a MHU within their community that provides integrated ID and substance use prevention and treatment services. The most notable finding is a gap in the literature, with few to no comparisons of models linking individuals recently released from the CJ system to integrated HIV, Hepatitis C, and OUD prevention and treatment and other harm reduction services. Further, few published studies address the geographical distinctions that affect service implementation and their effects on these substance use, ID and harm reduction care cascades. This manuscript makes specific recommendations to fill this gap through a detailed evaluation of PN and MHU linkage models to co-located and integrated HIV, Hepatitis C, and OUD prevention and treatment services across different communities within the U.S.