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

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.

Study Overview

• Status: Recruiting
• Conditions: Organizational Partnerships for Healthy Living; Standard of Care
• Intervention / Treatment: Behavioral: Organizational Partnerships for Healthy Living; Behavioral: Standard of Care

Detailed Description

A health-harming legal need is a social problem that adversely affects a person's health or access to health care and which is better remedied through the combination of legal care and health care. Medical legal partnerships (MLPs) have been underutilized as structural interventions; however, they could help improve HIV care continuum outcomes in health care organizations. 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. Two health care organizations serving PLWH Philadelphia, PA that do not currently provide any form of legal services to their patients will participate in this trial (n=200 PLWH). The proposed study is in response to PA-20-141: Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional). It is also responsive to two of the areas of high priority research of NIMH Division of AIDS Research (Develop and test interventions to improve HIV treatment outcomes; Advance the development and testing of interventions delivered beyond the individual level). Completion of this project will result in the development of an intervention package to optimize HIV services for a highly vulnerable population whose HIV care is affected by health-harming legal needs.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Omar Martinez, JD; Phone Number: 7862084340; Email: omar.martinez@ucf.edu
• Study Contact Backup: Name: Miguel Munoz-Laboy, DrPH; Email: miguel.munoz-laboy@stonybrook.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Recruiting
      • TPAC
      • Contact: Omar Martinez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Living with HIV (as confirmed by medical record)
• 18 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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical Legal Partnerships; 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; 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.; Other Names: OPHAL
Active Comparator: Standard of Care; 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; Comparison arm health organization will only receive the HIV standard of care (U.S. CDC HIV standard of care) and referral to legal aid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral Suppression	HIV viral load through HIV Nucleic Acid Amplification Test (NAAT) HIV by PCR HIV RNA Test	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in HIV Care	HIV primary care appointments and services at health organization (Attendance in the prior 3 months)	6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10	The Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 is a gauge of general healthcare-related quality of life.Response options are presented as 5-point (as well as a single 11-point) rating scales. The scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.	6 months

Collaborators and Investigators

• Sponsor: Temple University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R34MH125718 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No