Clinical trial NCT05286879: Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations
Official title: Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Infectious Disease
Risk Reduction Behavior
Substance Use
Substance Abuse
Stimulant Use Disorder
Keywords: Justice involvement
HIV Prevention
Hepatitis C Prevention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-03-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Living in one of our research areas
* Age 18 or older
* Able to provide written informed consent in English or Spanish
* Involvement with the criminal justice system within the last 6 months
* Living with HIV or being at risk of acquiring HIV and willing to learn about PrEP
* Willing to be tested for HIV (unless already confirmed via medical record)
* Having a history of opioid and/or stimulant use within 12 months prior to being in a controlled setting and/or in the last 6 months within the community
* Having a history of condomless sexual intercourse, STI diagnosis, and/or IDU within 6 months prior to being in a controlled setting and/or in the last 6 months within the community

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

Primary outcomes:
measure: Time to post-release initiation of ART medication
timeFrame: From the day of release/randomization to initiation of ART up to 6 months
measure: Time to post-release initiation of PrEP medication
timeFrame: From the day of release/randomization to initiation of PrEP up to 6 months
Secondary outcomes:
measure: Proportion of participants that initiate PrEP
timeFrame: From the day of release/randomization to initiation of PrEP up to 6 months
measure: Proportion of participants prescribed PrEP at end of intervention.
timeFrame: 6 months
measure: PrEP adherence by dried blood spot (DBS) testing
timeFrame: 6 months
measure: PrEP adherence by urine sample analysis
timeFrame: 6 months
measure: PrEP adherence by self-report
timeFrame: 6 months
measure: PrEP adherence assessed by prescription refill data
timeFrame: up to 6 months
measure: Retention in HIV PrEP care
timeFrame: up to 6 months
measure: Change in HIV status
timeFrame: Baseline and 12 months
measure: ART adherence by DBS testing
timeFrame: 6 months
measure: ART adherence by urine sample analysis
timeFrame: 6 months
measure: ART adherence by self-report
timeFrame: 6 months
measure: ART adherence by prescription refill
timeFrame: up to 6 months
measure: Retention in HIV ART care
timeFrame: up to 6 months
measure: HIV viral suppression
timeFrame: 6 months
measure: HIV Risk behaviors
timeFrame: from baseline up to 6 months
measure: Hepatitis C incidence
timeFrame: at baseline
measure: Hepatitis C incidence
timeFrame: 6 months
measure: Hepatitis C linkage
timeFrame: Day of release/randomization to appointment time up to 6 months
measure: Hepatitis C medication initiation via self-report
timeFrame: From baseline to reported treatment up to 6 months
measure: Hepatitis C medication initiation by prescription refill
timeFrame: up to 6 months
measure: Hepatitis C medication initiation by confirmation from provider
timeFrame: up to 6 months
measure: Hepatitis C medication completion by self-report
timeFrame: 6 months
measure: Hepatitis C medication completion by prescription refill
timeFrame: 6 months
measure: Hepatitis C medication completion by confirmation from provider
timeFrame: 6 months
measure: Hepatitis C sustained viral remission (SVR)
timeFrame: up to 6 months
measure: Hepatitis C re-infection
timeFrame: 12 months
measure: Opioid use
timeFrame: 6 months
measure: Number of opioid use days
timeFrame: 6 months
measure: Type of opioids used
timeFrame: 6 months
measure: Opioid abstinence
timeFrame: 6 months
measure: Substance use treatment participation
timeFrame: 6 months
measure: Linkage to medications for opioid use disorder (MOUD) via self report
timeFrame: From day of release/randomization to appointment for MOUD up to 6 months
measure: Linkage to medications for opioid use disorder (MOUD) via community provider
timeFrame: From day of release/randomization to appointment for MOUD up to 6 months
measure: MOUD retention by community provider
timeFrame: up to 6 months
measure: MOUD retention by self report
timeFrame: up to 6 months
measure: Substance use
timeFrame: 6 months
measure: Type of substances used
timeFrame: 6 months
measure: Substance use related overdoses at 6 months
timeFrame: 6 months
measure: Substance use related overdoses at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Fort Worth
country: United States
facility: Texas Christian University
state: Texas
Study officials:
affiliation: Yale University
name: Sandra A Springer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Springer SA, Nijhawan AE, Knight K, Kuo I, Di Paola A, Schlossberg E, Frank CA, Sanchez M, Pankow J, Proffitt RP, Lehman W, Pulitzer Z, Thompson K, Violette S, Harding KK; ACTION Cooperative Group. Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons. BMC Infect Dis. 2022 Apr 15;22(1):380. doi: 10.1186/s12879-022-07354-x.