Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06171919

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HIV

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, 32816, United States

Location status: Recruiting

Location contact

Amoy Fraser, PhD, CCRP, PMP

CONTACT

[email protected]

4072668742

Erica Martin, BS

CONTACT

[email protected]

4072668742

Omar Martinez, JD, MPH, MS

PRINCIPAL_INVESTIGATOR

About this study

Formerly incarcerated individuals are impacted by health-harming legal needs and risks, including lack of access to HIV care, unsafe housing safety, unstable employment, and other issues that often disrupt HIV care. Providing access to legal services can address barriers to HIV care and improve HIV care continuum outcomes for formerly incarcerated individuals. The proposed study, led by the University of Central Florida (Hispanic Serving Institution), together with the University of Miami, and Hope and Help Inc., aims to pilot test a comprehensive critical-time intervention medical legal partnership (CTI-MLP) approach to optimize timely HIV linkage, retention and viral suppression among formerly incarcerated individuals. MLPs have been used by social justice-oriented medical, health, social, and legal service practices to identify and address health-harming legal needs and risks that create barriers to treatment, care, and recovery for several health conditions. MLPs offer an integrated structural intervention that could improve HIV care continuum and psychosocial outcomes among formerly incarcerated individuals. Our CTI-MLP intervention package consists of: 1) training for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health-harming legal needs and risks impacting formerly incarcerated individuals, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) training for case managers and court advocate on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-locating legal services in health care agencies through MLP inter-organizational partnership; and 5) tailoring and implementing organizational best-practices in communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. In year 1, the investigators will engage a local community advisory board, scientific advisory board, and legal expert panel to finalize protocols and the Medical Legal Partnership Training Manual. In year 2, the investigators will implement the training and pilot test a CTI-MLP initiative with formerly incarcerated individuals living with HIV (n=100). Over a 6-month period, the team will collect (1) patients' health and functioning, including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life; (2) data on legal needs and risk factors; (3) patient HIV care clinical outcomes; and (4) clinic-level indicators, including provider-patient communication and readiness for continued implementation and sustainability. The study will be guided by Reach, Effectiveness, Adoption, Implementation, and Maintenance and Consolidated Framework for Implementation Research frameworks. Active engagement will ensure the effective translation and dissemination of our findings into practice. Completion this project will result in an innovative, evidence-based, community driven structural intervention to improve HIV care continuum outcomes among formerly incarcerated individuals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. HIV viral load using polymerase chain reaction (PCR)

    Time frame: 6 months

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

  2. HIV linkage and retention and antiretroviral therapy adherence using surveys

    Time frame: 6 months

Secondary outcomes

  1. Quality of Life checklist

    Time frame: 1 year

    A 36-item health questionnaire. It has 8 scales which provide a profile of functionally participant and welfare. The scales contain two general measures, the PCS (Physical Health Component Summary), and MCS (Mental Health Component Summary).

  2. Mental health indicators survey

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Amoy Fraser, PhD, CCRP, PMP

CONTACT

[email protected]

4072668742

Omar Martinez, JD, MPH, MS

CONTACT

[email protected]

4072668742

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.