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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    864
  • sponsor
    Yale University
Updated on 27 April 2022
opioid
opioid use
stimulant
injection drug

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 custody to the continuum of community-based HIV and opioid use disorder (OUD) prevention and treatment, medication for opioid use disorder (MOUD) service cascades of care.

Description

This 5-year Hybrid Type 1 Effectiveness-Implementation RCT trial compares two models of linking and retaining individuals recently released from custody 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, 864 CJ-involved individuals will be recruited across 2 CT (New London and Windham/Tolland/Middlesex 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:

  1. 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 custody. 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 PN and 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.

Details
Condition Opioid Use Disorder, Infectious Disease, Risk Reduction Behavior, Substance Use, Substance Abuse, Stimulant Use Disorder
Treatment Patient Navigator, Mobile Health Unit, Mobile Health Unit
Clinical Study IdentifierNCT05286879
SponsorYale University
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to provide written informed consent in English or Spanish
Involvement with the justice system in last 30 days
Have been HIV tested or be willing to have testing performed
If not living with HIV, willingness to start or learn more about PrEP
Have previous use of opioids or stimulants in 12 months prior to justice-involvement
Intends to live in the local area after release from custody or currently living in local area
Have pre-custody history of condomless sexual intercourse (vaginal or anal) and/or share injection drug use works within 6 months prior to justice-involvement

Exclusion Criteria

Severe medical or psychiatric disability making participation unsafe
Unable to provide consent
Not remaining in the local area after release from custody
Being released to inpatient care
Potential risk to research staff
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