HIV Provider Intervention to Address Intersectional Stigma and Medical Mistrust

Sponsor
RAND (Other)
Overall Status
Recruiting
CT.gov ID
NCT05803720
Collaborator
California Prevention Training Center (Other), Brigham and Women's Hospital (Other)
60
1
2
29.5
2

Study Details

Study Description

Brief Summary

Intersectional stigma and medical mistrust are prevalent among Black and Latina/Latino Americans living with HIV and are key contributors to racial/ethnic health disparities; yet, there are no evidence-based provider-level interventions available for HIV care providers to address intersectional stigma and medical mistrust with patients. The investigators propose to develop an online provider intervention, with community stakeholders' input, that provides psychoeducation and skills-building around addressing intersectional stigma and medical mistrust with patients. The investigators will conduct a pilot randomized controlled trial with 60 HIV care physicians (30/condition) to test the acceptability and feasibility of the online intervention and to determine preliminary effects (against a no-intervention control group) on providers' use of skills and HIV care delivery outcomes at baseline, immediate post, and 6-month follow-up.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Provider Intervention on Addressing Intersectional Stigma and Medical Mistrust in Patients with HIV
N/A

Detailed Description

The first aim will be an intervention development process that involves engaging community stakeholders to incorporate their input on the intervention manual and working with a provider training organization to develop an online platform for the initial pilot testing. The intervention will include psychoeducation and skills-building for providers to address intersectional stigma and mistrust, tailored to HIV care. This aim will include a usability test of the online intervention in 10 HIV clinical care providers. The second aim will be to conduct a pilot randomized controlled trial to compare two conditions (i.e., online provider intervention versus no-intervention control) on provider training outcomes (e.g., providers' use of skills learned in the intervention) and HIV care delivery outcomes (e.g., the estimated percentage of patients lost to care in the past year) measured at baseline, immediate post-intervention, and 6-month follow-up. Clinical providers (N = 60) providing care for patients living with HIV will be randomly assigned to the online provider intervention (n = 30) or control with no intervention (n = 30). The intervention will be delivered in groups (5-10 providers per group). A mixed-methods process evaluation at immediate post-intervention will determine the acceptability, feasibility, and appropriateness of the intervention, and will be used to refine the intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessors will be blind to the study condition assignment.
Primary Purpose:
Prevention
Official Title:
Development of an Online Provider Intervention to Address Intersectional Stigma and Medical Mistrust in People Living With HIV
Actual Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Provider Intervention

The intervention will consist of psychoeducation and skills-building for HIV care providers to gain the knowledge and skills needed to address intersectional stigma and medical mistrust with patients. The intervention will be online and conducted in groups.

Behavioral: Provider Intervention on Addressing Intersectional Stigma and Medical Mistrust in Patients with HIV
The intervention will consist of psychoeducation and skills-building for HIV care providers to gain knowledge and skills needed to address intersectional stigma and medical mistrust with patients. The intervention will be online and conducted in groups.

No Intervention: Control

No intervention control

Outcome Measures

Primary Outcome Measures

  1. Helpful/empathetic responses toward medial mistrust in hypothetical patient scenarios [Change from baseline to immediately after the intervention]

    Helpful/empathic responses will be operationalized as the number of motivational interviewing (MI)-consistent statements and validation used in the written responses; this variable will be obtained by coding the responses to the Helpful Response Questionnaire using the Motivational Interviewing Skills Coding for the number of validation and MI-consistent statements used in the written response.

  2. Provider use of strategies learned in the provider intervention in a role-play simulation of hypothetical patient scenarios [Change from baseline to immediately after the intervention]

    Provider use of strategies learned in the provider intervention in a role-play simulation will be obtained through coding that will be developed specifically for this study based on existing coding schemes (e.g., Motivational Interviewing Skills Coding, as appropriate). This variable will be calculated as the total number of strategies used during the role-play simulation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • clinical providers (including physicians, physician assistants, nurse practitioners, registered nurses/case managers) caring for patients living with HIV,

  • the majority of their patients are from racial/ethnic and sexual minority groups,

  • can make the time commitment to participate in the study.

Exclusion Criteria:
  • not HIV clinical providers

  • cannot make the time commitment to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 RAND Corporation Santa Monica California United States 90401

Sponsors and Collaborators

  • RAND
  • California Prevention Training Center
  • Brigham and Women's Hospital

Investigators

  • Principal Investigator: Lu Dong, PhD, RAND

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lu Dong, Full Behavioral/Social Scientist, RAND
ClinicalTrials.gov Identifier:
NCT05803720
Other Study ID Numbers:
  • 2021-N0035
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Mar 1, 2023
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 Apr 7, 2023