HIV Provider Intervention to Address Intersectional Stigma and Medical Mistrust

NCT05803720 | Completed Results DMC

• 1 other identifier: 2021-N0035
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Stigma, Social

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Provider Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

No intervention control

Interventions

Provider Intervention on Addressing Intersectional Stigma and Medical Mistrust in Patients with HIV BEHAVIORAL

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.

Provider Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• not HIV clinical providers
• cannot make the time commitment to participate

Sponsors & Collaborators

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

Study Sites (1)

RAND Corporation

Santa Monica, California, 90401, United States

Location

MeSH Terms

Conditions

Social Stigma

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Limitations and Caveats

The study sample consisted of self-selected HIV providers, which may limit the generalizability of findings to broader provider populations. The study used role-play simulations which were limited in capturing provider interaction with patients in real-world clinical encounters.

Results Point of Contact

• Title: Dr. Lu Dong
• Organization: RAND

ldong@rand.org

3103930411

Study Officials

• Lu Dong, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blind to the study condition assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Behavioral/Social Scientist

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: April 7, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Locations

US (1)