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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 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.

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

Conditions
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Opioid Use Disorder, Infectious Disease, Risk Reduction Behavior, Substance Use, Substance Abuse, Stimulant Use Disorder

Intervention / Treatment
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* Behavioral: Patient Navigator
* Behavioral: Mobile Health Unit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient Navigator<br>Navigators will assist linking study participants to appropriate community service providers | Behavioral: Patient Navigator<br>* 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<br>|
| Other: Mobile Health Unit<br>Study participants will be linked to a MHU within their community | Behavioral: Mobile Health Unit<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to post-release initiation of ART medication | Time to post-release initiation of ART for persons living with HIV. Measured by self-reported initiation within 6-months. ART initiation will be measured as the date of self-reported initiation within the 6-month intervention period. | From the day of release/randomization to initiation of ART up to 6 months | 
| Time to post-release initiation of PrEP medication | Time to post-release initiation of PrEP for participants not living with HIV. Measured by self-reported initiation within 6-months. PrEP initiation will be measured as the date of self-reported initiation within the 6-month intervention period. | From the day of release/randomization to initiation of PrEP up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants that initiate PrEP | The proportion of participants who initiate PrEP, of those who are not living with HIV, will be assessed via self-report and through confirmation with community provider | From the day of release/randomization to initiation of PrEP up to 6 months | 
| Proportion of participants prescribed PrEP at end of intervention. | Proportion of participants prescribed PrEP at end of intervention via self-report and through confirmation with community provider | 6 months | 
| PrEP adherence by dried blood spot (DBS) testing | For participants who initiate PrEP, adherence will be measured by DBS testing (Orasure, Inc) and defined as a tenofovir-disoproxil diphosphate (TFV-DP) level >700 fmol/punch at 6 months, reflecting cumulative dosing over 6-8 weeks and consistent with 4 or more doses of PrEP per week. | 6 months | 
| PrEP adherence by urine sample analysis | For participants who initiate PrEP, adherence will be assessed by TFV-DP urine testing, which measures recent (past 48 hour) dosing (Orasure, Inc.) | 6 months | 
| PrEP adherence by self-report | For participants who initiate PrEP, adherence will be assessed by self-reported PrEP adherence via Visual Analog Scale (VAS) | 6 months | 
| PrEP adherence assessed by prescription refill data | For participants who initiate PrEP, the proportion who are adherent based on continuous PrEP prescription refill will be assessed by date of prescription refill and number of pills per refill, via pharmacy data. | up to 6 months | 
| Retention in HIV PrEP care | Retention in PrEP care defined as attending 2 or more visits in 6-months post release will be assessed via self-report and through confirmation with community provider | up to 6 months | 
| Change in HIV status | Change in HIV status for participants testing negative using rapid point of care (POC) via Orasure tests at baseline that have a follow-up reactive HIV point of care test | Baseline and 12 months | 
| ART adherence by DBS testing | For participants living with HIV (PLH), adherence to ART treatment measured via the dry blood spot for for TFV-DP, level >700 fmol/punch at 6 months | 6 months | 
| ART adherence by urine sample analysis | For PLH, adherence to ART treatment measured via urine testing for TFV-DP based regimens. | 6 months | 
| ART adherence by self-report | For PLH, adherence to ART treatment will be assessed by self-reported ART adherence via Visual Analog Scale (VAS) | 6 months | 
| ART adherence by prescription refill | For participants who are prescribed ART, the proportion who are adherent based on continuous ART prescription refill will be assessed by date of prescription refill and number of pills per refill, via pharmacy data. | up to 6 months | 
| Retention in HIV ART care | For PLH, retention in HIV ART care: defined as attending 2 or more visits in 6-months post release will be assessed via self-report and through confirmation with community provider | up to 6 months | 
| HIV viral suppression | For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load < 200 copies/mL at 6 months | 6 months | 
| HIV Risk behaviors | Changes in injection and sexual risk behaviors, a summary item from Dr. Springer's HIV Risk Behavior tool created for NIDA Small Business Technology Transfer (STTR) will be used to assess sharing of injection equipment and other drug and sexual risk behaviors | from baseline up to 6 months | 
| Hepatitis C incidence | The proportion who test positive on rapid POC Hepatitis C virus (HCV) test with confirmatory reflex HCV viral load at baseline | at baseline | 
| Hepatitis C incidence | The proportion who test positive on rapid POC HCV test with confirmatory reflex HCV viral load at 6 months | 6 months | 
| Hepatitis C linkage | Time to linked appointment for HCV treatment during the 6 month intervention will be assessed via self-report and through confirmation with community provider | Day of release/randomization to appointment time up to 6 months | 
| Hepatitis C medication initiation via self-report | Time to HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via self-report VAS | From baseline to reported treatment up to 6 months | 
| Hepatitis C medication initiation by prescription refill | HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via prescription refill data | up to 6 months | 
| Hepatitis C medication initiation by confirmation from provider | Initiation of HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via confirmation with community provider | up to 6 months | 
| Hepatitis C medication completion by self-report | The proportion of participants prescribed DAAs who complete treatment will be assessed via self-report at 6 months | 6 months | 
| Hepatitis C medication completion by prescription refill | The proportion of participants prescribed DAAs who complete treatment will be assessed via prescription refill data at 6 months | 6 months | 
| Hepatitis C medication completion by confirmation from provider | The proportion of participants prescribed DAAs, who complete treatment will be assessed via confirmation with community provider at 6 months | 6 months | 
| Hepatitis C sustained viral remission (SVR) | The proportion of participants who achieve SVR at week 12 upon completion of DAA prescription medication, assessed as undetectable HCV viral load. | up to 6 months | 
| Hepatitis C re-infection | The proportion of participants, of those that achieve HCV SVR, that are re-infected with HCV at 12 months, via reactive rapid HCV POC test result | 12 months | 
| Opioid use | Opioid use (not as prescribed) will be assessed by the proportion of monthly urine samples negative vs. positive/missing | 6 months | 
| Number of opioid use days | Number of days of opioid use, not as prescribed, will be assessed using the timeline follow back (TLFB) method | 6 months | 
| Type of opioids used | Type of opioids used (not as prescribed) will be assessed by the Texas Christian University Drug Screen 5. | 6 months | 
| Opioid abstinence | The percent of opioid-free months by self-report via the timeline followback (TLFB). | 6 months | 
| Substance use treatment participation | Substance use treatment participation will be collected via self-report. Treatments include detoxification, residential treatment, and medication treatments. | 6 months | 
| Linkage to medications for opioid use disorder (MOUD) via self report | Time to linked appointment for MOUD treatment during the 6 month intervention will be assessed via self-report. | From day of release/randomization to appointment for MOUD up to 6 months | 
| Linkage to medications for opioid use disorder (MOUD) via community provider | Time to linked appointment for MOUD treatment during the 6 month intervention will be assessed via confirmation with community provider | From day of release/randomization to appointment for MOUD up to 6 months | 
| MOUD retention by community provider | Retention on MOUD type and dose of MOUD via confirmation from community provider | up to 6 months | 
| MOUD retention by self report | Retention on MOUD, using the Justice Community Opioid Innovation Network (JCOIN) instrument via self-reported type and dose of MOUD | up to 6 months | 
| Substance use | Use of other substances (e.g. stimulant, benzodiazepine, methylenedioxymethamphetamine, marijuana, and alcohol) not as prescribed, will be assess by the proportion of monthly urine samples negative vs. positive/missing | 6 months | 
| Type of substances used | Types of other substances used (e.g. stimulant, benzodiazepine, marijuana, synthetic cannabinoids, and alcohol) not as prescribed will be assessed self-reported via Texas Christian University Drug Screen 5 | 6 months | 
| Substance use related overdoses at 6 months | Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data | 6 months | 
| Substance use related overdoses at 12 months | Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Justice involvement, HIV Prevention, Hepatitis C Prevention