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

Sandra A. Springer, Department of Internal Medicine, Section of Infectious Disease, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT, 06510, USA. Sandra.springer@yale.edu.
Ank E. Nijhawan, Department of Internal Medicine, Division of Infectious Diseases and Geographic Medicine, University of Texas Southwestern Medical Center, Austin, TX, USA.
Kevin Knight, Institute of Behavioral Research, College of Science and Engineering, Texas Christian University, Fort Worth, TX, USA.
Irene Kuo, Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.
Angela Di Paola, Department of Internal Medicine, Section of Infectious Disease, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT, 06510, USA.
Esther Schlossberg, Department of Internal Medicine, Section of Infectious Disease, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT, 06510, USA.
Cynthia A. Frank, Department of Internal Medicine, Section of Infectious Disease, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT, 06510, USA.
Mark Sanchez, Department of Internal Medicine, Section of Infectious Disease, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT, 06510, USA.
Jennifer Pankow, Institute of Behavioral Research, College of Science and Engineering, Texas Christian University, Fort Worth, TX, USA.
Randi P. Proffitt, Institute of Behavioral Research, College of Science and Engineering, Texas Christian University, Fort Worth, TX, USA.
Wayne Lehman, Institute of Behavioral Research, College of Science and Engineering, Texas Christian University, Fort Worth, TX, USA.
Zoe Pulitzer, Department of Internal Medicine, Division of Infectious Diseases and Geographic Medicine, University of Texas Southwestern Medical Center, Austin, TX, USA.
Kelly Thompson, Alliance for Living, New London, CT, USA.
Sandra Violette, Connecticut Department of Correction, Wethersfield, CT, USA.
Kathleen K. Harding, Community Health Center, Inc, Middletown, CT, USA.

Document Type

Journal Article

Publication Date

4-15-2022

Journal

BMC infectious diseases

Volume

22

Issue

1

DOI

10.1186/s12879-022-07354-x

Keywords

HIV; Hepatitis C; Justice involvement; Mobile health unit; Opioid use disorder; Patient navigator; PrEP; Pre-exposure prophylaxis; Sexually transmitted infections; Stimulant use disorder

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.

Department

Epidemiology

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