Substance Use and HIV Action for Reentry and Engagement.

NCT06810973 | Enrolling By Invitation

• 2 other identifiers: STUDY00008607R61DA062365
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Jail Facilities; ART/PrEP

Outcome Measures

Primary Outcomes (2)

• Linkage to ART

  Linkage to ART care for individuals with lived experience of HIV or PrEP for PHRS.

  3 months

• Program Retention

  Program Retention at 3 months

  3 months

Study Arms (3)

SUCCESS-E

EXPERIMENTAL

Participants with SUD, living with HIV or at high risk for seroconversion, will be placed in strength-based case management, delivered by a case manager and peer navigators, both in jail and in the community, leading to linkage and retention in healthcare and SUD treatment.

Behavioral: SUCCESS-E

Control Group

OTHER

Participants not placed in the intervention group will have healthcare services inform them of possible medical homes for HIV/PrEP care and a list of referral sites for follow-up SUD care.

Behavioral: Enhanced Standard of Care

Key informant interviews (KII)

OTHER

Jail staff and community members willing to participate in Key Informant Interviews (KIIs)

Behavioral: Key Informant Interviews

Interventions

SUCCESS-E BEHAVIORAL

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 for HIV care/PrEP 6. Future transitions

Also known as: Sustained, Unbroken, Connection to Care Entry Services, and Suppression/Stopping of HIV, Enhanced with Peer Navigators

SUCCESS-E

Enhanced Standard of Care BEHAVIORAL

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.

Control Group

Key Informant Interviews BEHAVIORAL

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.

Also known as: KII

Key informant interviews (KII)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Fulton County Jail

Atlanta, Georgia, 30318, United States

Location

MeSH Terms

Interventions

Sulfamethazine

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Anne Spaulding, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after study completion.
• Access Criteria: Data will be shared electronically with fellow researchers for secondary data analysis by request.

Locations

US (1)