NCT05286879

Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 5-year Hybrid Type 1 Effectiveness-Implementation Randomized Control Trial (RCT) that compares two models of linking and retaining individuals recently released from justice involvement to the continuum of community-based HIV prevention and treatment, HCV treatment, STI treatment, and opioid use disorder (OUD) prevention and treatment, medication for opioid use disorder (MOUD) service cascades of care.

Detailed description

This 5-year Hybrid Type 1 Effectiveness-Implementation RCT trial compares two models of linking and retaining individuals recently released from justice involvement to the continuum of community-based HIV and OUD prevention and treatment (MOUD) service cascades of care. A significant innovation of this RCT is that it will be delivered within 4 communities where coalition infrastructures have been established as part of the Justice Community Opioid Innovation Network (JCOIN) studies, a National Institute on Drug Abuse (NIDA)-funded Cooperative Agreement initiative to mitigate the impact criminal justice (CJ)-involved individuals with OUD are having on local communities, and the investigators will be able to build on that existing infrastructure. Specifically, up to 960 CJ-involved individuals will be recruited across 2 CT (New London/Middlesex Counties and Windham/Tolland/New Haven/Hartford Counties) \& 2 Texas (Dallas and Tarrant Counties) high risk communities. HIV status will be assessed via rapid testing at initial point of contact. Participants will be randomized to receive at post-release either: a) a Patient Navigator (PN) system for care, wherein navigators will assist linking study participants to appropriate community service providers (e.g., OUD/SUD treatment including MOUD, and HCV testing and treatment; those not living with HIV will be provided access to pre-exposure prophylaxis (PrEP) services, and those living with HIV will receive assistance with gaining initial or continued access to antiretroviral therapy (ART) services, or b) services delivered via a Mobile Health Unit (MHU) within the participants community where participants will receive PrEP/ART, MOUD, and harm reduction services on the MHU or assistance from a community health worker (CHW) in linking to appropriate community-based OUD and other medical and behavioral health providers. The interventions will last for 6 months post-release from custody. The focus of this study is the randomized controlled trial. Study objectives: Aim 1 (Intervention Effectiveness) Primary: To compare the effectiveness of PN vs. MHU service delivery on participant length of time to initiating post-release PrEP (prevention)/ART (treatment) medication within 6 months following release from justice involvement. Secondary outcomes will examine the continuum of PrEP and HIV care outcomes, including (but not limited to) the following additional HIV-related measures: viral suppression for people living with HIV (PLH), PrEP adherence, HIV risk behaviors; HCV Measures: HCV testing \& linkage to treatment. Importantly, the investigators will also assess OUD and Substance Use Disorders (SUD)-related measures: OUD/SUD diagnoses, MOUD prescription receipt \& retention, opioid \& stimulant use, and overdose incidents. Other outcomes of interest include sexually transmitted infection (STI) incidence; and primary medical care appointments. Aim 2 (Implementation): To evaluate Patient Navigation (PN ) and Mobile Health Unit (MHU) feasibility, acceptability, and costs. Primary implementation outcomes include feasibility (health care utilization impact among released individuals, contributions of interagency workgroup members on outcomes); acceptability (participant satisfaction, perceived usefulness); sustainment (continued utilization), and costs required to implement and sustain the approaches as well as to scale-up in additional communities. Additional outcomes will examine the broader impact on community health care including other health services accessed, expanded OUD services, and common barriers (e.g., stigma) to service access across the community provider spectrum. The investigators will also assess cost offsets and effectiveness of the service delivery models on the cascade outcomes. A Persons Who Inject Drugs (PWID) sub-study will focus on gaining insight into participant and social context (inner and outer) factors associated with the effectiveness outcomes.

Conditions

• Opioid Use Disorder
• Infectious Disease
• Risk Reduction Behavior
• Substance Use
• Substance Abuse
• Stimulant Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Patient Navigator	Linkage to services for OUD/SUD treatment including MOUD, Hepatitis C virus (HCV) testing and treatment; those not living with HIV infection will be provided access to PrEP services, and those living with HIV will receive assistance with gaining initial or continued access to ART services during the 6-month post-release intervention period
BEHAVIORAL	Mobile Health Unit	Participants will receive HIV PrEP/ HIV ART, MOUD, harm reduction services on the MHU and or assistance from a community health worker in linking to appropriate community-based OUD and other medical and behavioral health providers across the 6 month post-release intervention period

Timeline

• Start date: 2022-03-31
• Primary completion: 2025-07-31
• Completion: 2025-12-12
• First posted: 2022-03-18
• Last updated: 2026-04-02

Locations

3 sites across 1 country: United States