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

• ClinicalTrials.gov Identifier: NCT05286879
• Recruitment Status: Recruiting
• First Posted: March 18, 2022
• Last Update Posted: April 12, 2024
• Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Yale University

Tracking Information

• First Submitted Date: February 25, 2022
• First Posted Date: March 18, 2022
• Last Update Posted Date: April 12, 2024
• Actual Study Start Date: March 31, 2022
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 9, 2022)

• Time to post-release initiation of ART medication [ Time Frame: 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.
• Time to post-release initiation of PrEP medication [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 9, 2022)

• Proportion of participants that initiate PrEP [ Time Frame: 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
• Proportion of participants prescribed PrEP at end of intervention. [ Time Frame: 6 months ]
  Proportion of participants prescribed PrEP at end of intervention via self-report and through confirmation with community provider
• PrEP adherence by dried blood spot (DBS) testing [ Time Frame: 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.
• PrEP adherence by urine sample analysis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
• Retention in HIV PrEP care [ Time Frame: 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
• Change in HIV status [ Time Frame: 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 DBS testing [ Time Frame: 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
• ART adherence by urine sample analysis [ Time Frame: 6 months ]
  For PLH, adherence to ART treatment measured via urine testing for TFV-DP based regimens.
• ART adherence by self-report [ Time Frame: 6 months ]
  For PLH, adherence to ART treatment will be assessed by self-reported ART adherence via Visual Analog Scale (VAS)
• ART adherence by prescription refill [ Time Frame: 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.
• Retention in HIV ART care [ Time Frame: 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
• HIV viral suppression [ Time Frame: 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
• HIV Risk behaviors [ Time Frame: 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 [ Time Frame: at baseline ]
  The proportion who test positive on rapid POC Hepatitis C virus (HCV) test with confirmatory reflex HCV viral load at baseline
• Hepatitis C incidence [ Time Frame: 6 months ]
  The proportion who test positive on rapid POC HCV test with confirmatory reflex HCV viral load at 6 months
• Hepatitis C linkage [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 6 months ]
  HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via prescription refill data
• Hepatitis C medication initiation by confirmation from provider [ Time Frame: up to 6 months ]
  Initiation of HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via confirmation with community provider
• Hepatitis C medication completion by self-report [ Time Frame: 6 months ]
  The proportion of participants prescribed DAAs who complete treatment will be assessed via self-report at 6 months
• Hepatitis C medication completion by prescription refill [ Time Frame: 6 months ]
  The proportion of participants prescribed DAAs who complete treatment will be assessed via prescription refill data at 6 months
• Hepatitis C medication completion by confirmation from provider [ Time Frame: 6 months ]
  The proportion of participants prescribed DAAs, who complete treatment will be assessed via confirmation with community provider at 6 months
• Hepatitis C sustained viral remission (SVR) [ Time Frame: 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.
• Hepatitis C re-infection [ Time Frame: 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 [ Time Frame: 6 months ]
  Opioid use (not as prescribed) will be assessed by the proportion of monthly urine samples negative vs. positive/missing
• Number of opioid use days [ Time Frame: 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 [ Time Frame: 6 months ]
  Type of opioids used (not as prescribed) will be assessed by the Texas Christian University Drug Screen 5.
• Opioid abstinence [ Time Frame: 6 months ]
  The percent of opioid-free months by self-report via the timeline followback (TLFB).
• Substance use treatment participation [ Time Frame: 6 months ]
  Substance use treatment participation will be collected via self-report. Treatments include detoxification, residential treatment, and medication treatments.
• Linkage to medications for opioid use disorder (MOUD) via self report [ Time Frame: 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 [ Time Frame: 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
• MOUD retention by community provider [ Time Frame: up to 6 months ]
  Retention on MOUD type and dose of MOUD via confirmation from community provider
• MOUD retention by self report [ Time Frame: up to 6 months ]
  Retention on MOUD, using the Justice Community Opioid Innovation Network (JCOIN) instrument via self-reported type and dose of MOUD
• Substance use [ Time Frame: 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
• Type of substances used [ Time Frame: 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
• Substance use related overdoses at 6 months [ Time Frame: 6 months ]
  Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data
• Substance use related overdoses at 12 months [ Time Frame: 12 months ]
  Occurrence of non-fatal and fatal substance use related overdoses, through self-report, confirmation with medical providers, and mortality index data

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

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

Intervention

• 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

Study Arms

• Patient Navigator
  Navigators will assist linking study participants to appropriate community service providers
  Intervention: Behavioral: Patient Navigator
• Mobile Health Unit
  Study participants will be linked to a MHU within their community
  Intervention: Behavioral: Mobile Health Unit

• Publications *: 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 9, 2022): 864
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2025
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sandra Springer, MD; 203-687-6680; sandra.springer@yale.edu

Contact: Cynthia Frank, PhD; 203-745-8630; cyndi.frank@yale.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05286879
• Other Study ID Numbers: 2000029346; 1U01DA053039-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Yale University
• Original Responsible Party: Same as current
• Current Study Sponsor: Yale University
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Sandra A Springer, MD; Yale University

• PRS Account: Yale University
• Verification Date: April 2024