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

NCT ID: NCT06171919

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV

Keywords

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HIV Care Incarcerated

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CTI-MLP approach

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

Group Type EXPERIMENTAL

Organizational Partnerships

Intervention Type 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 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

Group Type EXPERIMENTAL

HIV Continuum Care

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Hope and Help Center of Central Florida Incorporated

UNKNOWN

Sponsor Role collaborator

University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Central Florida

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Omar Martinez, JD, MPH, MS

Role: CONTACT

Phone: 4072668742

Email: [email protected]

Amoy Fraser, PhD, CCRP, PMP

Role: CONTACT

Phone: 4072668742

Email: [email protected]

Facility Contacts

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Amoy Fraser, PhD, CCRP, PMP

Role: primary

Erica Martin, BS

Role: backup

Omar Martinez, JD, MPH, MS

Role: backup

Other Identifiers

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3P30MH133399-01S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006010

Identifier Type: -

Identifier Source: org_study_id