Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations
- Conditions
- Risk Reduction BehaviorInfectious DiseaseSubstance UseSubstance AbuseStimulant Use DisorderOpioid Use Disorder
- Interventions
- Behavioral: Mobile Health UnitBehavioral: Patient Navigator
- Registration Number
- NCT05286879
- Lead Sponsor
- Yale University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mobile Health Unit Mobile Health Unit Study participants will be linked to a MHU within their community Patient Navigator Patient Navigator Navigators will assist linking study participants to appropriate community service providers
- Primary Outcome Measures
Name Time Method Time to post-release initiation of PrEP medication From the day of release/randomization to initiation of PrEP up to 6 months 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.
Time to post-release initiation of ART medication From the day of release/randomization to initiation of ART up to 6 months 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.
- Secondary Outcome Measures
Name Time Method ART adherence by self-report 6 months For PLH, adherence to ART treatment will be assessed by self-reported ART adherence via Visual Analog Scale (VAS)
Retention in HIV ART care up to 6 months 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
Hepatitis C medication completion by confirmation from provider 6 months The proportion of participants prescribed DAAs, who complete treatment will be assessed via confirmation with community provider at 6 months
ART adherence by DBS testing 6 months 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
PrEP adherence by urine sample analysis 6 months For participants who initiate PrEP, adherence will be assessed by TFV-DP urine testing, which measures recent (past 48 hour) dosing (Orasure, Inc.)
PrEP adherence by self-report 6 months For participants who initiate PrEP, adherence will be assessed by self-reported PrEP adherence via Visual Analog Scale (VAS)
PrEP adherence assessed by prescription refill data up to 6 months 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.
Hepatitis C linkage Day of release/randomization to appointment time up to 6 months Time to linked appointment for HCV treatment during the 6 month intervention will be assessed via self-report and through confirmation with community provider
Hepatitis C medication initiation via self-report From baseline to reported treatment up to 6 months Time to HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via self-report VAS
Hepatitis C medication initiation by prescription refill up to 6 months HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via prescription refill data
Hepatitis C medication completion by prescription refill 6 months The proportion of participants prescribed DAAs who complete treatment will be assessed via prescription refill data at 6 months
Proportion of participants that initiate PrEP From the day of release/randomization to initiation of PrEP up to 6 months 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
Change in HIV status Baseline and 12 months 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
ART adherence by prescription refill up to 6 months 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.
Hepatitis C sustained viral remission (SVR) up to 6 months The proportion of participants who achieve SVR at week 12 upon completion of DAA prescription medication, assessed as undetectable HCV viral load.
MOUD retention by community provider up to 6 months Retention on MOUD type and dose of MOUD via confirmation from community provider
PrEP adherence by dried blood spot (DBS) testing 6 months 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.
ART adherence by urine sample analysis 6 months For PLH, adherence to ART treatment measured via urine testing for TFV-DP based regimens.
HIV Risk behaviors from baseline up to 6 months 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
Hepatitis C incidence 6 months The proportion who test positive on rapid POC HCV test with confirmatory reflex HCV viral load at 6 months
Opioid abstinence 6 months The percent of opioid-free months by self-report via the timeline followback (TLFB).
Substance use treatment participation 6 months Substance use treatment participation will be collected via self-report. Treatments include detoxification, residential treatment, and medication treatments.
Type of substances used 6 months 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
Proportion of participants prescribed PrEP at end of intervention. 6 months Proportion of participants prescribed PrEP at end of intervention via self-report and through confirmation with community provider
Retention in HIV PrEP care up to 6 months 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
HIV viral suppression 6 months 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
Hepatitis C medication completion by self-report 6 months The proportion of participants prescribed DAAs who complete treatment will be assessed via self-report at 6 months
Number of opioid use days 6 months Number of days of opioid use, not as prescribed, will be assessed using the timeline follow back (TLFB) method
Type of opioids used 6 months Type of opioids used (not as prescribed) will be assessed by the Texas Christian University Drug Screen 5.
MOUD retention by self report up to 6 months Retention on MOUD, using the Justice Community Opioid Innovation Network (JCOIN) instrument via self-reported type and dose of MOUD
Hepatitis C medication initiation by confirmation from provider up to 6 months Initiation of HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via confirmation with community provider
Linkage to medications for opioid use disorder (MOUD) via self report From day of release/randomization to appointment for MOUD up to 6 months Time to linked appointment for MOUD treatment during the 6 month intervention will be assessed via self-report.
Linkage to medications for opioid use disorder (MOUD) via community provider From day of release/randomization to appointment for MOUD up to 6 months Time to linked appointment for MOUD treatment during the 6 month intervention will be assessed via confirmation with community provider
Substance use 6 months 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
Substance use related overdoses at 12 months 12 months Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data
Hepatitis C re-infection 12 months 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
Opioid use 6 months Opioid use (not as prescribed) will be assessed by the proportion of monthly urine samples negative vs. positive/missing
Substance use related overdoses at 6 months 6 months Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data
Trial Locations
- Locations (3)
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Texas Christian University
🇺🇸Fort Worth, Texas, United States