Recruiting
Phase 1

HIV Continuity

Sponsor:

Temple University

Code:

NCT05912842

Conditions

Organizational Partnerships for Healthy Living

Standard of Care

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Organizational Partnerships for Healthy Living

Standard of Care

Study Details

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

Study ID

NCT05912842

Start date

Oct 1, 2022

Status verified date

Jun, 2023

Completion date

Jun, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Viral Suppression [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

TPAC

Recruiting

Philadelphia, Pennsylvania, United States, 19102

More Information

Sponsor

Temple University

Last update posted

Jun 23, 2023

Last verified

Jun, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2023-06-23.