Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462807
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-11
Brief Title:
Improving the Organizational Social Context to Address Structural Racism and Discrimination
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Improving the Organizational Social Context to Address Structural Racism and Discrimination A Randomized Controlled Trial to Reduce Racial Disparities in Viral Suppression and Retention in HIV Care
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite the widespread use of effective antiretroviral therapy ART the HIV epidemic continues to impact racial and ethnic minority populations disproportionately Although BlackAfrican American persons account for 13 of the US 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 racialethnic 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 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 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 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
Although the outpatient setting is a vitally important aspect of care provision for 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 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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None