Enhancing the Organizational Social Context to Improve Viral Suppression and Retention in HIV Care

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06462807
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARC — BEHAVIORAL
    ARC is an evidence-based intervention that uses three strategies (ARC principles, ARC component tools, and ARC mental models) to create organizational social contexts (OSCs) that support the implementation of interventions to improve patient outcomes.

Study Details

Despite the widespread use of effective antiretroviral therapy (ART), the HIV epidemic continues to impact racial and ethnic minority populations disproportionately. Although Black/African American persons account for 13% of the U.S. population, they account for 41% of new HIV diagnoses and experience the lowest rates of retention in HIV care and viral suppression (VS) compared to other racial/ethnic groups. Structural racism and discrimination (SRD) likely contribute to racial disparities in HIV outcomes. Although the outpatient setting is a vitally important aspect of care provision for people living with HIV (PLWH), there are limited data on the impact of intra-organizational SRD on HIV outcomes. Longitudinal engagement in HIV care is needed for sustained VS and decreased community transmission of HIV. The organizational social context (OSC) includes organizational culture (organizational norms and values that drive quality of care), organizational climate (perception of the culture and how it impacts personal well-being), and workers' attitudes. Using a randomized controlled trial (RCT), we will implement ARC (Accessibility, Responsiveness, Continuity) to improve organizational behavior and reduce racial disparities in HIV outcomes for PLWH. ARC is an evidence-based intervention that uses three strategies (ARC principles, ARC component tools, and ARC mental models) to create OSCs that support the implementation of interventions to improve patient outcomes. Clinics will be randomized to ARC (n = 2) or standard of care (SOC; n= 2). Those assigned to ARC will address SRD occurring at the organizational level affecting care, including referral and treatment patterns for PLWH. A pre-implementation period will be followed by ARC and ARC-associated implementation strategies for 36 months and then a 12-month post-implementation period where we will continue to measure HIV outcomes in both arms. We will compare HIV outcomes, namely VS and retention in care, and intermediate outcomes, such as linkage to mental health treatment and staff turn-over in clinics assigned to ARC and SOC. We will also evaluate whether individual (self-efficacy, perceived discrimination) and organizational factors (OSC and cohesion of OSC measures) mediate the relationship between ARC, intermediate, and HIV outcomes. In preparation to the RCT, we will evaluate baseline OSC measures across 12 HIV clinics in Philadelphia and determine aspects of the OSC associated with VS and retention in care in a multi-level model adjusting for neighborhood SRD, patient-level factors, and clustering of patients nested in clinics and neighborhoods. We will then test the effectiveness of ARC in improving a primary outcome of VS and secondary outcome of retention in care at the end of the implementation period. We will examine the acceptability, sustainability, and cost of implementing ARC in outpatient HIV care. This research will advance understanding of the impact of SRD on HIV treatment outcomes and health services research and the implementation of a disseminable evidence-based practice aimed at reducing SRD.

Key Dates

Start date
Sep 5, 2025
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Accessibility, Responsiveness, Continuity (ARC)
  • No Intervention: Standard of Care (SOC)

Primary Outcome Measure

Viral Suppression [ Time Frame: 12-month period ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Florence Momplaisir, MD
[email protected]
215-746-8555

Find similar trials in Philadelphia, PA

By condition
HIV
By specialty
Infectious disease
By research site
University of Pennsylvania· Philadelphia, PA

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