Ending the HIV Epidemic With Equity: an Intervention to Reduce the Impact of Racism and Discrimination (TRAnscenDS)

Ending the HIV Epidemic: An All-facility Intervention to Reduce the Impact of Structural Racism and Discrimination on Patient and Healthcare

The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs to reduce structural racism and discrimination (SRD) against Black, Indigenous, People of Color (BIPOC) living with HIV (PLH) and BIPOC healthcare workers. Six RWHAP clinics will be selected to participate and be assigned to one of three sequences (two clinics per cluster). All members will complete participate in interactive trainings to raise awareness of and reduce SRD, from the clinic policy level, to attitudes, to the clinic environment. All clinic members and select patients will complete self-administered surveys every 6 months over 18 months.

Study Overview

• Status: Recruiting
• Conditions: Hiv; Discrimination, Racial; Stigmatization; Racism
• Intervention / Treatment: Behavioral: TRAncenDS

Detailed Description

The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce structural racism and discrimination (SRD) against Black, Indigenous, People of Color (BIPOC) living with HIV (PLH) and BIPOC healthcare workers. SRD directly impacts access to and uptake of healthcare for BIPOC, including engagement in HIV services across the continuum of prevention and care. The proposed intervention, titled TRAnscenDS, draws on the evidence-based Health Policy Plus (HP+) 'total' facility HIV stigma-reduction intervention and Contact Theory of demonstrated efficacy in reducing race-related intergroup prejudice. TRAnscenDS targets the clinics' organizational (e.g.,anti-racist and diversity, equity and inclusion (DEI) policies) and systems (e.g., staff attitudes/behaviors) levels to affect patient (e.g., experienced and perceived discrimination, HIV care, mental health) outcomes and staff (e.g., job satisfaction) wellbeing, at the individual level. Findings will yield a Manual for implementing total-facility SRD-reduction processes and content. Other RWHAP-funded clinics and facilities serving marginalized groups may be able to adopt this manualized yet highly adaptable intervention packet to support BIPOC.

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta Scheinmann, MPH; Phone Number: 917-769-8078; Email: rs536@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University School of Nursing
      • Contact: Corina Lelutiu-Weinberger, PhD; Email: cl4265@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Selected Ryan White Clinics. Selection based on the following:

First, clinic leaders will complete a 15-min Site Characteristics Survey, assessing suitability for participation and clinic comparability for randomization purposes. Staff and leadership at Ryan White clinics will next complete an anonymous 15-minute Eligibility Survey. Clinics will meet initial eligibility if scores are between 4-5 (showing high motivation) on 90% of the items.

Exclusion Criteria:

• Non-Ryan White Clinics
• Clinics that do not serve a primarily BIPOC population
• Clinics that are not interested in addressing Structural Racism and Discrimination

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First Cluster; The intervention will be implemented across three steps with a total of 6 clinics (two clinics per step). The earliest roll-out of the intervention will be at the clinics randomized to Cluster 1. The intervention consists of a mix of Workshops, Interactive Trainings and Learning Circles (virtual and in-person). In the first workshop, the investigators will present baseline findings to all clinic members to 1) raise awareness for the need for intervention to reduce Structural Racism and Discrimination (SRD) , 2) facilitate collaborative processes, 3) catalyze change for practice transformation, to 4) guide the intervention process. This workshop will be followed by a series of interactive trainings covering topics from the history of structural racism, to intersectional stigma and discrimination, bias, systems of accountability, and the creation of a manual to guide the implementation and sustainability of SRD reduction efforts.	Behavioral: TRAncenDS; The HP+ curriculum includes total-site training and co-facilitation via participatory modules. To transform clinic culture, a multi-level approach that includes the whole facility and reaches all parties is required. The intervention aims to modify top-down mechanisms of influence. TRAnscenDS is modeled on these principles and supports the development of multiple SRD-reduction strategies (instituting comprehensive anti-racist and Diversity, Equity and Inclusion policies, monitoring and feedback systems; workforce equity), at the top two levels of the socioecological model (organizational/policy and systems/providers/staff), to in turn impact individual-level out-comes.; Other Names: Health Policy+ infused with SRD-relevant content and activities
Experimental: Second Cluster; The intervention will be implemented across three steps with a total of 6 clinics (two clinics per step). The earliest roll-out of the intervention will be at the clinics randomized to Cluster 1. The intervention consists of a mix of Workshops, Interactive Trainings and Learning Circles (virtual and in-person). In the first workshop, the investigators will present baseline findings to all clinic members to 1) raise awareness for the need for intervention to reduce Structural Racism and Discrimination (SRD) , 2) facilitate collaborative processes, 3) catalyze change for practice transformation, to 4) guide the intervention process. This workshop will be followed by a series of interactive trainings covering topics from the history of structural racism, to intersectional stigma and discrimination, bias, systems of accountability, and the creation of a manual to guide the implementation and sustainability of SRD reduction efforts.	Behavioral: TRAncenDS; The HP+ curriculum includes total-site training and co-facilitation via participatory modules. To transform clinic culture, a multi-level approach that includes the whole facility and reaches all parties is required. The intervention aims to modify top-down mechanisms of influence. TRAnscenDS is modeled on these principles and supports the development of multiple SRD-reduction strategies (instituting comprehensive anti-racist and Diversity, Equity and Inclusion policies, monitoring and feedback systems; workforce equity), at the top two levels of the socioecological model (organizational/policy and systems/providers/staff), to in turn impact individual-level out-comes.; Other Names: Health Policy+ infused with SRD-relevant content and activities
Experimental: Third Cluster; The intervention will be implemented across three steps with a total of 6 clinics (two clinics per step). The earliest roll-out of the intervention will be at the clinics randomized to Cluster 1. The intervention consists of a mix of Workshops, Interactive Trainings and Learning Circles (virtual and in-person). In the first workshop, the investigators will present baseline findings to all clinic members to 1) raise awareness for the need for intervention to reduce Structural Racism and Discrimination (SRD) , 2) facilitate collaborative processes, 3) catalyze change for practice transformation, to 4) guide the intervention process. This workshop will be followed by a series of interactive trainings covering topics from the history of structural racism, to intersectional stigma and discrimination, bias, systems of accountability, and the creation of a manual to guide the implementation and sustainability of SRD reduction efforts.	Behavioral: TRAncenDS; The HP+ curriculum includes total-site training and co-facilitation via participatory modules. To transform clinic culture, a multi-level approach that includes the whole facility and reaches all parties is required. The intervention aims to modify top-down mechanisms of influence. TRAnscenDS is modeled on these principles and supports the development of multiple SRD-reduction strategies (instituting comprehensive anti-racist and Diversity, Equity and Inclusion policies, monitoring and feedback systems; workforce equity), at the top two levels of the socioecological model (organizational/policy and systems/providers/staff), to in turn impact individual-level out-comes.; Other Names: Health Policy+ infused with SRD-relevant content and activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Structural Racial Discrimination Index (SRD)	The SRD is a rating of clinic mission/vision statements, the anti-racist policy, diversity, equity and Inclusion, and the clinic environment. A change in the mean score of SRD Index, post-intervention implementation will be measured. Scores range from 0-100, with a higher score indicating increased anti-racist and DEI policies and procedures.	Baseline and 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modern Racism Scale (MRS) Score	The MRS is a scale of racial attitudes and consists of 7 items worded as opinion statements. One item, which is considered non-racist is reverse coded before scoring. The response scale is 1= strongly disagree to 5= strongly agree. Scores range from 7-35 with a lower score indicating a better outcome.	Baseline and 18 months
Change in Cultural Humility Score	Cultural humility as measured by the adapted Trauma-Informed, Resilience-Oriented Care (TI-ROC) Cultural Humility Scale, which assess staff's perceptions of colleagues and clinic environment. Scores range from 12-60. The negative items are reverse coded such that higher scores indicate higher cultural humility indicating better outcome.	Baseline and 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time to Linkage to Care	Change in time to linkage to care from diagnosis at the clinics.	Baseline and 18 months
Change in Patients Retained in Care	Change in the number of patients retained in care at the clinics.	Baseline and 18 months
Change in Number of Patients HIV Virally Suppressed	Change in the number of patients virally suppressed at the clinics. Viral suppression defined as less than 200 copies/mL.	Baseline and 18 months
Change in Frequency of Perceived Racism and Discrimination	Change in the frequency of perceived racism and discrimination events by patients attending the clinic as collected by self-administered Experiences of Discrimination survey .	Baseline and 18 months
Change in the Frequency of HIV-Related Stigma	Change in the frequency of HIV-related stigma events by patients attending the clinics. Stigma measured by the Adapted Stigma 2.0 index.	Baseline and 18 months
Change in Depression, Anxiety and Stress Scale (DASS-21)	A 21-item scale that assesses depression, anxiety and stress over the past week. Scores range from 0-63 with a lower score indicating a better outcome.	Baseline and 18 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Nursing Research (NINR); Florida State University; RTI International; Rutgers University
• Investigators: Principal Investigator: Corina Lelutiu-Weinberger, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AAAU1559; 1R01NR020583 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No