Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons
Authors: Springer Sandra A. , Nijhawan Ank E. , Knight Kevin , Kuo Irene , Di Paola Angela , Schlossberg Esther , Frank Cynthia A. , Sanchez Mark , Pankow Jennifer , Proffitt Randi P. , Lehman Wayne , Pulitzer Zoe , Thompson Kelly , Violette Sandra , Harding Kathleen K. ,   ACTION Cooperative Group, Brooks Ralph , Heimer Robert , Schultheis Alysse , Van der Wyk Brent , Hansen Laura , Torres M. Brynn , Becan Jenny , Bennett Ahrein Johnson , Crawley Rachel , Joe George , Jones Justin , Villare Stephanie , Behrends Czarina , Jalali Ali , Muggeo Jennifer , Acosta Melissa , DeMoss Dustin , Persaud Donna , Johannsen-Love Jill , Davis Frank 
Published: April 2022

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.