What side effects are associated with this type of intervention?

Common treatments for people living with HIV, particularly antiretroviral therapy (ART), can have several side effects. Nucleoside reverse transcriptase inhibitors (NRTIs) may cause nausea, headache, and fatigue. Non-nucleoside reverse transcriptase inhibitors (NNRTIs) can lead to rash and liver toxicity. Protease inhibitors (PIs) are associated with gastrointestinal issues and lipid abnormalities. Integrase strand transfer inhibitors (INSTIs) might cause insomnia and weight gain. Despite these side effects, ART is essential for managing HIV and improving the quality of life for PLWH.

What prior FDA approvals exist?

The FDA has approved various antiretroviral therapies (ART) as the standard of care for people living with HIV (PLWH), including drugs like tenofovir, emtricitabine, and efavirenz, which are often used in combination to manage HIV infection effectively. Additionally, integrated care models that combine medical treatment with social and legal support have been recognized for their potential to improve health outcomes. These models, similar to the OPAHL intervention, aim to address the comprehensive needs of PLWH by providing coordinated care that includes medical, behavioral, and legal services.

What other types of research exist?

Promising alternatives to OPAHL for PLWH include: 1) Medical-Legal Partnerships (MLPs) that integrate legal services directly into healthcare settings to address social determinants of health; 2) Co-located care models that bring together multidisciplinary teams, including healthcare providers, social workers, and legal experts, within the same facility; 3) Digital health platforms that offer telehealth services combined with virtual legal consultations to ensure continuous support; and 4) Community-based integrated care programs that leverage local resources and partnerships to provide holistic care, including legal assistance, tailored to the needs of PLWH.

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Medical-Legal Partnerships for HIV Care Continuity

Phase 1

Recruiting

Research Sponsored by Temple University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program called OPAHL that combines healthcare and legal support for people living with HIV. It aims to help those by addressing legal issues that affect their health. The program trains staff, includes legal experts, and provides on-site legal services.

Who is the study for?

This trial is for adults living with HIV who have a viral load over 200 copies/mL. Participants must be willing to consent to the study and not plan on moving within six months after joining. It's designed for those receiving care at health organizations involved in the trial.

What is being tested?

The study tests an intervention called OPAHL, aiming to improve HIV care through training healthcare staff, integrating legal expertise into case management, co-locating legal services in healthcare agencies, and enhancing communication protocols among providers.

What are the potential side effects?

Since this trial focuses on organizational interventions rather than medical treatments, it does not involve medication side effects. However, participants may experience changes in service delivery or access that could affect their satisfaction or continuity of care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Viral Suppression

Secondary study objectives

Engagement in HIV Care

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Medical Legal PartnershipsExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments in Standard of Care for PLWH, as exemplified by the OPAHL intervention, involve a multilevel approach that integrates medical, social, and legal support. This includes comprehensive training for healthcare staff on the HIV continuum of care, embedding legal expertise within healthcare teams, and co-locating legal services in healthcare settings. These mechanisms aim to address health-harming legal risks and needs, fostering a collaborative environment that supports patient autonomy and choice. This integrated approach is crucial for improving health outcomes and ensuring continuity of care for PLWH.

Trust in pathways? Professionals' sensemaking of care pathways in the Norwegian mental health services system.