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

Sandra A Springer, Ank E Nijhawan, Kevin Knight, Irene Kuo, Angela Di Paola, Esther Schlossberg, Cynthia A Frank, Mark Sanchez, Jennifer Pankow, Randi P Proffitt, Wayne Lehman, Zoe Pulitzer, Kelly Thompson, Sandra Violette, Kathleen K Harding, ACTION Cooperative Group, Ralph Brooks, Robert Heimer, Alysse Schultheis, Brent Van der Wyk, Laura Hansen, M Brynn Torres, Jenny Becan, Ahrein Johnson Bennett, Rachel Crawley, George Joe, Justin Jones, Stephanie Villare, Czarina Behrends, Ali Jalali, Jennifer Muggeo, Melissa Acosta, Dustin DeMoss, Donna Persaud, Jill Johannsen-Love, Frank Davis, Sandra A Springer, Ank E Nijhawan, Kevin Knight, Irene Kuo, Angela Di Paola, Esther Schlossberg, Cynthia A Frank, Mark Sanchez, Jennifer Pankow, Randi P Proffitt, Wayne Lehman, Zoe Pulitzer, Kelly Thompson, Sandra Violette, Kathleen K Harding, ACTION Cooperative Group, Ralph Brooks, Robert Heimer, Alysse Schultheis, Brent Van der Wyk, Laura Hansen, M Brynn Torres, Jenny Becan, Ahrein Johnson Bennett, Rachel Crawley, George Joe, Justin Jones, Stephanie Villare, Czarina Behrends, Ali Jalali, Jennifer Muggeo, Melissa Acosta, Dustin DeMoss, Donna Persaud, Jill Johannsen-Love, Frank Davis

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.

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

Conflict of interest statement

Author Springer has provided scientific consultation to Alkermes Inc and received NIH and VA grant funding. Dr. Springer has received in-kind study drug donations from Alkermes Inc and Indivior Pharmaceutical Company for NIH-funded research. The authors alone are responsible for the content and writing of this paper.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Project design
Fig. 2
Fig. 2
Participant flow through project

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