Infectious Disease, Opioid Use Disorder, Risk Reduction Behavior, Stimulant Use Disorder, Substance Abuse, Substance Use
Conditions
Keywords
Justice involvement, HIV Prevention, Hepatitis C Prevention
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. 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.
Interventions
BEHAVIORALPatient 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
BEHAVIORALMobile 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
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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 self-report | 6 months | For PLH, adherence to ART treatment will be assessed by self-reported ART adherence via Visual Analog Scale (VAS) |
| 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 |
| 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 |
| Type of opioids used | 6 months | Type of opioids used (not as prescribed) will be assessed by the Texas Christian University Drug Screen 5. |
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSandra A Springer, MD
Yale University
Outcome results
None listed