Forging Sustainable Solutions for HIV Continuity of Care Through Medical-legal Partnerships

NCT05912842 | Unknown Phase 1 DMC

• 1 other identifier: R34MH125718
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test the Organizational Partnerships for Healthy Living (OPAHL) intervention through a feasibility and acceptability trial. OPAHL is an innovative, multilevel intervention package intended for health care organizations serving people living with HIV (PLWH). It was developed through a prior study (grant #: R21 MH115820) using intervention mapping methodology and community-scientific collaborative boards. OPAHL consists of: 1) training (7/8hours) for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health harming legal risks and needs, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) case management training on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-location of legal services in health care agencies through MLP inter-organizational partnership within 3 months; and 5) organizationally tailored implementation of best-practice communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. The specific aims of this study are: 1) to refine the OPAHL intervention prototype for implementation with PLWH with detectable viral loads and 2) to test the feasibility, acceptability and preliminary effects sizes of OPAHL. Given the current COVID-19 pandemic, the study will also explore MLP opportunities that respond at the intersection of HIV/AIDS and COVID-19 prevention and treatment.

Conditions

Organizational Partnerships for Healthy Living; Standard of Care

Outcome Measures

Primary Outcomes (1)

• Viral Suppression

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

  6 months

Secondary Outcomes (2)

• Engagement in HIV Care

  6 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10

  6 months

Study Arms (2)

Medical Legal Partnerships

EXPERIMENTAL

Component 1 is a comprehensive training for all MLP care providers delivered to clinical, social and behavioral, and legal staff together to establish a collaborative environment. Component 2 consists of the screening tool and screening protocol that is designed to identify health-harming legal needs of PLWH patients. Component 3 includes the provision of legal support through partnership with the Legal Clinic for the Disabled. Upon a positive legal needs screening, the case manager connects the patient to this attorney, at which point the patient, after signing a letter of engagement, becomes a client and can now address the identified legal issue(s) with legal representation.

Behavioral: Organizational Partnerships for Healthy Living

Standard of Care

ACTIVE COMPARATOR

Comparison arm health organization will only receive the HIV standard of care (U.S. CDC HIV standard of care) and referral to legal aid.

Behavioral: Standard of Care

Interventions

Organizational Partnerships for Healthy Living BEHAVIORAL

Component 1 is a comprehensive training for all MLP care providers delivered to clinical, social and behavioral, and legal staff together to establish a collaborative environment. Component 2 consists of the screening tool and screening protocol that is designed to identify health-harming legal needs of PLWH patients. Component 3 includes the provision of legal support through partnership with the Legal Clinic for the Disabled.

Also known as: OPHAL

Medical Legal Partnerships

Standard of Care BEHAVIORAL

Comparison arm health organization will only receive the HIV standard of care (U.S. CDC HIV standard of care) and referral to legal aid.

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Living with HIV (as confirmed by medical record)
• years or older
• HIV viral load of more than 200 copies/mL (as confirmed by medical record)
• 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

• Temple University: lead

Study Sites (1)

TPAC

Philadelphia, Pennsylvania, 19102, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Omar Martinez, JD

CONTACT

7862084340; omar.martinez@ucf.edu

Miguel Munoz-Laboy, DrPH

CONTACT

miguel.munoz-laboy@stonybrook.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigative team will conduct a clustered-randomized small-scale trial in two HIV treatment services organizations in Philadelphia. One agency will be randomized to the OPAHL intervention, consisting of integrated legal support (n=100 PLWH) and one agency will be randomized to the standard of care, legal aid referral (n=100 PLWH).

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: October 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

US (1)