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

Sponsor
Columbia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05785169
Collaborator
National Institute of Nursing Research (NINR) (NIH), Rutgers University (Other), Florida State University (Other), RTI International (Other)
6
3
43

Study Details

Study Description

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 18 months.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: TRAncenDS
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
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).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).
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Ending the HIV Epidemic: An All-facility Intervention to Reduce the Impact of Structural Racism and Discrimination on Patient and Healthcare
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cluster 1

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: Cluster 2

    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: Cluster 3

    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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Structural Racial Discrimination Index (SRD) [Baseline and 18 months]

      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.

    Secondary Outcome Measures

    1. Change in Modern Racism Scale (MRS) Score [Baseline and 18 months]

      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.

    2. Change in Cultural Humility Score [Baseline and 18 months]

      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.

    Other Outcome Measures

    1. Change in Time to Linkage to Care [Baseline and 18 months]

      Change in time to linkage to care from diagnosis at the clinics.

    2. Change in Patients Retained in Care [Baseline and 18 months]

      Change in the number of patients retained in care at the clinics.

    3. Change in Number of Patients HIV Virally Suppressed [Baseline and 18 months]

      Change in the number of patients virally suppressed at the clinics. Viral suppression defined as less than 200 copies/mL.

    4. Change in Frequency of Perceived Racism and Discrimination [Baseline and 18 months]

      Change in the frequency of perceived racism and discrimination events by patients attending the clinic as collected by self-administered Experiences of Discrimination survey .

    5. Change in the Frequency of HIV-Related Stigma [Baseline and 18 months]

      Change in the frequency of HIV-related stigma events by patients attending the clinics. Stigma measured by the Adapted Stigma 2.0 index.

    6. Change in Depression, Anxiety and Stress Scale (DASS-21) [Baseline and 18 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Columbia University
    • National Institute of Nursing Research (NINR)
    • Rutgers University
    • Florida State University
    • RTI International

    Investigators

    • Principal Investigator: Corina Lelutiu-Weinberger, PhD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Corina Lelutiu-Weinberger, Associate Professor of Health Sciences Research, Columbia University
    ClinicalTrials.gov Identifier:
    NCT05785169
    Other Study ID Numbers:
    • AAAU1559
    • 1R01NR020583
    First Posted:
    Mar 27, 2023
    Last Update Posted:
    Mar 27, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 27, 2023