Clinical trial NCT05785169: Ending the HIV Epidemic With Equity: an Intervention to Reduce the Impact of Racism and Discrimination
Official title: Ending the HIV Epidemic: An All-facility Intervention to Reduce the Impact of Structural Racism and Discrimination on Patient and Healthcare
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Discrimination, Racial
Stigmatization
HIV
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Rutgers University
name: Florida State University
name: RTI International
name: Duke University
First posted: 2023-03-27
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The intervention will be implemented across three steps with a total of 6 clinics (2 clinics per step). This stepped-wedge design will use stratified randomization to assign the timing of the intervention to one of 3 study sequences. Clinics would have been selected based on serving a majority of Black patients. Other characteristics (e.g., poverty level) will be assessed at selection to ensure equivalence across the groups of clusters; selection of clinics will restrict on these variables. The criterion used to randomize clinics (by strata) to one of the 3 study sequences will be urbanicity (rural/suburban vs urban), which accounts for clinic size (# patients/year). Within each of the 2 strata, 3 clinics will be randomized to one of the 3 groups of clusters. Stratified Randomization will be conducted in Statistical Analysis System (SAS).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 24 months.

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.,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 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.

Eligibility criteria: 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.

Within each clinic, both clinic staff and patients will be invited to participate.

Exclusion Criteria:

* Non-Ryan White Clinics
* Clinics that do not serve a primarily BIPOC population
* Clinics that are not interested in participating

Primary outcomes:
measure: Change in Structural Racial Discrimination Index (SRD)
timeFrame: Baseline, 6, 12, 18, and 24 months
Secondary outcomes:
measure: Change in Modern Racism Scale (MRS) Score
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in Cultural Humility Score
timeFrame: Baseline, 6, 12, 18, and 24 months
Other outcomes:
measure: Change in Time to Linkage to Care
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in Patients Retained in Care
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in Number of Patients HIV Virally Suppressed
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in Frequency of Perceived Racism and Discrimination
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in Intersectional Stigma
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in Depression and Anxiety
timeFrame: Baseline, 6, 12, 18, and 24 months
Locations:
city: New York
country: United States
facility: Columbia University School of Nursing
state: New York
Study officials:
affiliation: Columbia University
name: Corina Lelutiu-Weinberger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Felicia A Browne, ScD
role: PRINCIPAL_INVESTIGATOR
References: