Clinical trial NCT06810973: The Hub for Research in Atlanta on Addressing SUD to Promote HIV Elimination at Reentry (THRASHER)
Official title: The Hub for Research in Atlanta on Addressing SUD to Promote HIV Elimination at Reentry (THRASHER)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: HIV
Keywords: Jail Facilities
ART/PrEP
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During the two-year R61 phase, the investigators will compare the Intervention vs Enhanced Standard of Care. The investigators will work with new criminal legal institutions and conduct interviews among recently released PWH/PHRS to see how transitional needs in new jurisdictions differ from those experienced by those in FCJ. Building relationships in the R61 phase will position the researchers to scale up a larger study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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)?

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)

Primary outcomes:
measure: Linkage to ART
timeFrame: 3 months
measure: Program Retention
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Fulton County Jail
state: Georgia
Study officials:
affiliation: Emory University
name: Anne Spaulding, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: