Substance Use and HIV Action for Reentry and Engagement.

Overview

This study will test a behavioral intervention with a case manager/peer navigator team pairing with clients to deliver transition planning services. The interactions help clients recognize and use their strengths. The goal is to see if this approach improves clients' ability to access healthcare and drug treatment after being released from jail.

Detailed description

The goal of this jail-based study is to test an intervention aimed at helping individuals with substance use disorder (SUD) who have HIV or are at high risk of contracting HIV maintain medications for managing or preventing HIV when transitioning back to the community. Approximately 75% of individuals in jail have SUD and a subset of this group either has HIV or is at risk of seroconversion. People living with HIV require antiretroviral medications to suppress the virus to non-infectious levels, but these medications are often discontinued during the chaotic period following release from jail. Those at risk of HIV can also take antiretroviral therapy as a preventive measure to lower the risk of seroconversion.

Preliminary data suggest that SUCCESS-E, a strengths-based case management and peer navigation program developed via a pilot grant, can help connect individuals to medical care upon release to ensure continued drug therapy. A manual for delivering SUCCESS-E was previously developed to guide case managers and peer navigators.

In this phase, 100 eligible individuals will be enrolled from the Fulton County Jail (FCJ). Participants will be randomly assigned to one of two groups: SUCCESS-E intervention or controls receiving an enhanced version of the jail's discharge planning services.

Data will be collected through medical chart reviews, baseline and follow-up surveys with participants (each taking less than an hour), and single-visit interviews with approximately 30 stakeholders (jail staff, community advocates, and individuals post-program). These key informant interviews will typically last less than an hour and will be recorded for qualitative analysis. Data will also be collected to estimate the cost of delivering the intervention.

The project will apply implementation science to introduce innovations in case management for transitioning individuals from jail back to the community. The case management intervention will be delivered to individuals with HIV or those at high risk of seroconversion, both in jail and post-release. If proven effective, this strategy could help reduce the incidence of new HIV cases by maintaining viral suppression in individuals with HIV and ensuring that those at risk for HIV seroconversion remain on preventive therapy.

The study will focus on individuals, with or without HIV, who have SUD and are either incarcerated or have been released from jails in Georgia within the past six weeks. Participants will ideally be within one week of their release.

The study aims to address the following questions:

* For people without HIV, how can they access a clinic offering HIV prevention medication (Pre-Exposure Prophylaxis, or PrEP)? * For people living with HIV, how can they access a clinic to receive their HIV medications (Antiretroviral Therapy, or ART)? * For everyone, how can they get treatment for Substance Use Disorder (SUD)?

Interventions

• Behavioral SUCCESS-E
  SUCCESS-E is a previously developed intervention based on the evidence-based Antiretroviral Treatment and Access to Services (ARTAS) intervention, modified for those detained within a jail system. It is a manualized six-session program delivered by a case management team, composed of a professional case manager and paraprofessional peer navigators. In Jail Sessions: 1. Build Trust 2. Assess Strengths 3. Explore life on ART Post-Release Sessions: 4. Link with care 5. Enhance self-efficacy f
• Behavioral Enhanced Standard of Care
  A list of referral sites for follow-up SUD care will be shared. This information sharing without strength-based, longitudinal case management will be an enhancement to treatment as usual. Also, information about HIV/PrEP follow-up in the community will be placed around the jail, such as affixed to the nurses' medication carts that they push from housing unit to unit, twice a day when residents are due for prescription medications.
• Behavioral Key Informant Interviews
  Key informant interviews (KII) will be conducted with jail staff and community stakeholders in the R61 phase to examine perceptions, barriers, and facilitators to SUD and HIV/PrEP service and treatment utilization, as well as document the experiences of SUCCESS-E participants from the pilot phase.

Primary outcome measures

• Linkage to ART [Time frame: 3 months]
• Program Retention [Time frame: 3 months]

Eligibility criteria

Inclusion Criteria for Participants:

• Cis- and transgender men and women
• Able to understand and give informed consent
• Willing to participate in study activities
• People with HIV (PWH) or people at high risk of seroconversion (PHRS)
• History of SUD, defined as a score of 2 or more items in the past year on the Justice Community Opioid Innovation Network (JCOIN) SUD assessment tool
• Resident of study jail and agree to participate in the SUCCESS-E program, or released from study jail within six weeks, and agree to participate in the SUCCESS-E program

Inclusion Criteria for Participants in R61 KIIs:

• Participant who completed the intervention or
• A jail administrator/staff member
• Able to give informed consent
• Willing to participate in study activities

Exclusion criteria

• Uncontrolled serious mental illness or moderate to severe intellectual impairment, and/or cognitive impairment (inability to comprehend the informed consent document as assessed by study staff during enrollment)
• Admission to a prison facility (Federal or state)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Fulton County Jail — Atlanta

Identifiers

NCT: NCT06810973 · STUDY00008607 · R61DA062365

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗