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

Abstract

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.

HIV Risk and Interest in Preexposure Prophylaxis in Justice-Involved Population

“…This study was a preliminary descriptive analysis of baseline assessments conducted for persons enrolled in a hybrid type 1 effectiveness-implementation randomized controlled trial comparing patient navigation to mobile health unit (MHU) for linking justice-involved persons to community-based HIV and substance use disorder (SUD) prevention and treatment services ( 27 ). Recruitment across 4 study sites in Texas and Connecticut began March 2022.…”

“…Recruitment across 4 study sites in Texas and Connecticut began March 2022. Potential participants were referred by facility staff in jail, prison, court-mandated drug treatment, parole/probation, and the community on the basis of published processes ( 27 ). For persons in facilities, staff referred any persons who met eligibility criteria.…”

“…We entered data into a centralized REDCap database according to study protocol ( 27 ). We summarized binary and categorical variables by using frequencies and assessed continuous variables by using means.…”

Characterizing Interest in and Uptake of Preexposure Prophylaxis for HIV Prevention Among Men in a US State Correctional System

“…12 Only a few studies have assessed perceived barriers and facilitators to PrEP care among incarcerated populations, and there are a limited number of interventions to improve PrEP care outcomes that were conducted or evaluated in correctional settings. 13,14 Comparatively, barriers to PrEP use in community settings have been more thoroughly characterized. Known barriers include low awareness of PrEP, low self-perceived risk of HIV acquisition, stigma, and high cost of PrEP clinical care and insurance coverage.…”

“…The PrEP care continuum has not been comprehensively characterized among incarcerated populations 12 . Only a few studies have assessed perceived barriers and facilitators to PrEP care among incarcerated populations, and there are a limited number of interventions to improve PrEP care outcomes that were conducted or evaluated in correctional settings 13,14 . Comparatively, barriers to PrEP use in community settings have been more thoroughly characterized.…”