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

Hiv Clinical Trial

— TRAnscenDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785169
• Other study ID #: AAAU1559
• Secondary ID: 1R01NR020583
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: January 2027

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: Roberta Scheinmann, MPH
• Phone: 917-769-8078
• Email: rs536[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Discrimination, Racial
• Hiv
• Racism
• Stigmatization

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University School of Nursing	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Columbia University	Florida State University, National Institute of Nursing Research (NINR), RTI International, Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Time to Linkage to Care	Change in time to linkage to care from diagnosis at the clinics.	Baseline and 18 months
Other	Change in Patients Retained in Care	Change in the number of patients retained in care at the clinics.	Baseline and 18 months
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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