Recruiting

Observational Study

Sponsor:

University of Central Florida

Code:

NCT06171919

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Organizational Partnerships

HIV Continuum Care

Study Details

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

Study ID

NCT06171919

Start date

Oct 5, 2024

Status verified date

Feb, 2026

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CTI-MLP approach

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

experimental: CTI-MLP assessment

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

Interventions

Organizational Partnerships

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.

HIV Continuum Care

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.

Primary outcome measure

  • HIV viral load using polymerase chain reaction (PCR) [ Time Frame: 6 months ]
  • HIV linkage and retention and antiretroviral therapy adherence using surveys [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Omar Martinez, JD, MPH, MS

4072668742omar.martinez@ucf.edu

Amoy Fraser, PhD, CCRP, PMP

4072668742amoy.fraser@ucf.edu

Locations

University of Central Florida

Recruiting

Orlando, Florida, United States, 32816

Contacts

Amoy Fraser, PhD, CCRP, PMP

4072668742amoy.fraser@ucf.edu

Erica Martin, BS

4072668742erica.martin@ucf.edu

Principal Investigator:

Omar Martinez, JD, MPH, MS

More Information

Sponsor

University of Central Florida

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • HIV
  • Care
  • Incarcerated

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Central Florida on 2026-02-23.