The Hub for Research in Atlanta on Addressing SUD to Promote HIV Elimination at Reentry (THRASHER)

Not Applicable

• Conditions: HIV

• Registration Number: NCT06810973
• Lead Sponsor: Emory University

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)?

Study Timeline

• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-06
• Status Verified: 2025-06
• Study Start: 2025-06-09
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Primary Completion: 2029-12
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Linkage to ART	3 months	Linkage to ART care for individuals with lived experience of HIV or PrEP for PHRS.
Program Retention	3 months	Program Retention at 3 months

Trial Locations

Locations (1)

Fulton County Jail; 🇺🇸 Atlanta, Georgia, United States