HIV Provider Intervention to Address Intersectional Stigma and Medical Mistrust

Development of an Online Provider Intervention to Address Intersectional Stigma and Medical Mistrust in People Living With HIV

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.

Study Overview

• Status: Completed
• Conditions: Stigma, Social
• Intervention / Treatment: Behavioral: Provider Intervention on Addressing Intersectional Stigma and Medical Mistrust in Patients with HIV

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90401
      • RAND Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios	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. This measure is a count variable and the values ranging above or equal to 0 (no maximum). Higher values represent a better outcome.	Baseline, 2-monts after the baseline assessment, and 6-month follow-up
Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios	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 training-consistent strategies used during the role-play simulation. This measure is a count variable and the values ranging above or equal to 0 (no maximum). Higher values represent a better outcome.	Baseline and 2-month after the baseline assessment
Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios	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 training-inconsistent strategies used during the role-play simulation. This measure is a count variable and the values ranging above or equal to 0 (no maximum). Higher values represent a better outcome.	Baseline and 2-month after the baseline assessment

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: Brigham and Women's Hospital; California Prevention Training Center
• Investigators: Principal Investigator: Lu Dong, PhD, RAND

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: March 25, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Social Behavior; Social Stigma; Immune System Phenomena; Seroconversion
• Other Study ID Numbers: 2021-N0035

Drug and device information, study documents

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