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

NCT06462807 | Recruiting

• 1 other identifier: 2022-38
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Viral Suppression

  HIV-1 RNA \<400 copies per milliliter

  12-month period

Secondary Outcomes (1)

• Retention in HIV Care

  12-month period

Study Arms (2)

Accessibility, Responsiveness, Continuity (ARC)

EXPERIMENTAL

Behavioral: ARC

Standard of Care (SOC)

NO INTERVENTION

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.

Accessibility, Responsiveness, Continuity (ARC)

Eligibility Criteria

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

You may qualify if:

• Aim 1:
• PLWH: in care in one of 12 clinics in Philadelphia
• HIV diagnosis date at least one year prior to the administration of the clinic OSC measures
• Philadelphia address at the time of HIV diagnosis
• successfully linked to care at any point during the study period, defined as having documentation of 1 or more CD4 or Viral Load test results after the date of diagnosis
• Clinic workers: clinic leaders, administrators, frontline staff, and providers across participating clinics
• Aim 2:
• PLWH: having an established diagnosis of HIV and receiving care at one of the 4 clinics at least 6 months before the pre-implementation period
• Clinic workers: the entire pool of workers employed in the 2 clinics assigned to the intervention arm will be invited to participate in ARC
• Aim 3:
• \- Clinic staff and PLWH at clinics receiving ARC

You may not qualify if:

• Aim 1:
• PLWH: Persons in a correctional facility will be excluded from this analysis
• Clinic workers: Participants who are not employed in one of the roles that were designated
• Aim 2:
• PLWH: Patients who get discharged from a clinic because they moved (or for other reasons) or who died will not be eligible to enter the pre-implementation cohort.
• Clinic workers: Clinics assigned to SOC will not receive ARC but will be asked to complete surveys using the same schedule as the clinics assigned to receive ARC.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: September 5, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

US (1)