Improving HIV Care Continuum Outcomes Among Formerly Incarcerated Individuals Through Critical Time Legal Interventions

NCT06171919 | Recruiting

• 2 other identifiers: STUDY000060103P30MH133399-01S2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to better understand the impact of receiving legal aid on HIV care continuum outcomes among formerly incarcerated individuals. In addition, the investigators would like to assess the effectiveness of a comprehensive training for providers in increasing knowledge about medical legal partnerships and improving clinic level outcomes, including communication among providers. The training includes several topics including health disparities impacting formerly incarcerated individuals, health-harming legal needs and risks, screening for health-harming legal needs and risks, medical-legal partnership structure and operations, prerequisites for MLPs, embedding legal expertise within regularized case management, co-location of legal services, and data collection and analysis.

Conditions

HIV

Keywords

HIV; Care; Incarcerated

Outcome Measures

Primary Outcomes (2)

• HIV viral load using polymerase chain reaction (PCR)

  HIV viral load through HIV Nucleic Acid Amplification Test (NAAT) HIV by PCR HIV RNA Test

  6 months

• HIV linkage and retention and antiretroviral therapy adherence using surveys

  6 months

Secondary Outcomes (2)

• Quality of Life checklist

  1 year

• Mental health indicators survey

  1 year

Study Arms (2)

CTI-MLP approach

EXPERIMENTAL

To finalize protocols and a medical-legal partnership training manual for health and social service providers at Hope and Help Inc.

Other: Organizational Partnerships

CTI-MLP assessment

EXPERIMENTAL

To assess the feasibility and acceptability of a comprehensive critical-time intervention medical legal partnership (CTI-MLP) approach to improve HIV care continuum outcomes among formerly incarcerated individuals and determine the most efficient mechanisms for CTI-MLP delivery

Other: HIV Continuum Care

Interventions

Organizational Partnerships OTHER

Component 1 is a comprehensive training for all MLP care providers delivered to clinical, social and behavioral, and legal staff to establish a collaborative environment. Component 2 consists of the screening tool and screening protocol that is designed to identify health-harming legal needs and risks of formerly incarcerated individuals living with HIV. Component 3 includes the provision of legal support.

CTI-MLP approach

HIV Continuum Care OTHER

Participants will be included in the pilot trial. The investigative team will work with the staff at Hope and Help Inc. to identify and recruit those out of care through reviewing electronic medical records.

CTI-MLP assessment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Living with HIV (as confirmed by medical record)
• HIV viral load of more than 200 copies/mL (as confirmed by medical record)
• Report history of incarceration
• Willing and able to consent to participate in the trial (including accessing their medical records at the health care organization)
• No intent to relocate within the 6 months following their enrollment in the study.

You may not qualify if:

• Individuals who self-report having been sentenced to serve under state or federal custody, with a sentence to begin within 6 months from proposed enrollment in the study

Sponsors & Collaborators

• University of Central Florida: lead
• University of Miami: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Hope and Help Center of Central Florida Incorporated: collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

RECRUITING

Central Study Contacts

Omar Martinez, JD, MPH, MS

CONTACT

4072668742; omar.martinez@ucf.edu

Amoy Fraser, PhD, CCRP, PMP

CONTACT

4072668742; amoy.fraser@ucf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: December 15, 2023
• Study Start: October 5, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)