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

Substance Abuse Clinical Trial

— ACTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286879
• Other study ID #: 2000029346
• Secondary ID: 1U01DA053039-01
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Sandra Springer, MD
• Phone: 203-687-6680
• Email: sandra.springer[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 538
• Est. completion date: March 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease
• Opioid Use Disorder
• Opioid-Related Disorders
• Risk Reduction Behavior
• Stimulant Use Disorder
• Substance Abuse
• Substance Use
• Substance-Related Disorders

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
• 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

Locations

Country	Name	City	State
United States	UT Southwestern	Dallas	Texas
United States	Texas Christian University	Fort Worth	Texas
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	ART adherence by urine sample analysis	For PLH, adherence to ART treatment measured via urine testing for TFV-DP based regimens.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hepatitis C incidence	The proportion who test positive on rapid POC HCV test with confirmatory reflex HCV viral load at 6 months	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Opioid use	Opioid use (not as prescribed) will be assessed by the proportion of monthly urine samples negative vs. positive/missing	6 months
Secondary	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
Secondary	Type of opioids used	Type of opioids used (not as prescribed) will be assessed by the Texas Christian University Drug Screen 5.	6 months
Secondary	Opioid abstinence	The percent of opioid-free months by self-report via the timeline followback (TLFB).	6 months
Secondary	Substance use treatment participation	Substance use treatment participation will be collected via self-report. Treatments include detoxification, residential treatment, and medication treatments.	6 months
Secondary	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
Secondary	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
Secondary	MOUD retention by community provider	Retention on MOUD type and dose of MOUD via confirmation from community provider	up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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