NCT Number: NCT05286879
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Yale School of Medicine, New Haven, Connecticut, United States
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.
Note: The study sample size was revised from 864 to 538 participants following identification of an error in the original power analysis, which incorrectly used HIV-positive initiation rates to estimate the overall effect size. A revised power analysis was conducted, and the updated sample size was reviewed and approved by the Data and Safety Monitoring Board (DSMB) during its August 2023 review.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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 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.
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
Time frame: 6 months
Proportion of participants prescribed PrEP at end of intervention via self-report and through confirmation with community provider
Time frame: 6 months
For participants who initiate PrEP, adherence will be assessed by self-reported PrEP adherence via Visual Analog Scale (VAS)
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
Time frame: 6 months
For PLH, adherence to ART treatment will be assessed by self-reported ART adherence via Visual Analog Scale (VAS)
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
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
Time frame: 6 months
Type of opioids used (not as prescribed) will be assessed by the Texas Christian University Drug Screen 5.
Time frame: 6 months
The percent of opioid-free months by self-report via the timeline followback (TLFB).
Time frame: 6 months
Substance use treatment participation will be collected via self-report. Treatments include detoxification, residential treatment, and medication treatments.
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
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
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
Time frame: 6 months
For participants who initiate PrEP, adherence will be measured by DBS testing (Orasure, Inc.) and defined as a tenofovirdisoproxil 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.
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.)
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.
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
Time frame: 6 months
For participants living with HIV (PLH), adherence to ART treatment measured via the dry blood spot for TFV-DP, level >700 fmol/punch at 6 months
Time frame: 6 months
For PLH, adherence to ART treatment measured via urine testing for TFV-DP based regimens.
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.
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 selfreport and through confirmation with community provider
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
Time frame: 6 months
The proportion who test positive on rapid POC HCV test with confirmatory HCV viral load at 6 months
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
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
Time frame: up to 6 months
HCV direct acting antiviral treatment (DAAs) during the 6 month will be assessed via prescription refill data
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
Time frame: 6 months
The proportion of participants prescribed DAAs who complete treatment will be assessed via self-report at 6 months
Time frame: 6 months
The proportion of participants prescribed DAAs who complete treatment will be assessed via prescription refill data at 6 months
Time frame: 6 months
The proportion of participants prescribed DAAs, who complete treatment will be assessed via confirmation with community provider at 6 months
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.
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
Time frame: 6 months
Opioid use (not as prescribed) will be assessed by the proportion of monthly urine samples negative vs. positive/missing
Time frame: 6 months
Number of days of opioid use, not as prescribed, will be assessed using the timeline follow back (TLFB) method
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
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
Time frame: up to 6 months
Retention on MOUD type and dose of MOUD via confirmation from community provider
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
Time frame: 6 months
Use of other substances (e.g. stimulant, benzodiazepine, methylenedioxymethamphetamine, marijuana, and alcohol) not as prescribed, will be assessed by the proportion of monthly urine samples negative vs. positive/missing
Yale University
Other
Acronym: ACTION
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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