HIV Provider Intervention to Address Intersectional Stigma and Medical Mistrust

Stigma, Social Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05803720
• Other study ID #: 2021-N0035
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stigma, Social

Intervention

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.

Locations

Country	Name	City	State
United States	RAND Corporation	Santa Monica	California

Sponsors (3)

Lead Sponsor	Collaborator
RAND	Brigham and Women's Hospital, California Prevention Training Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to immediately after the intervention
Primary	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 strategies used during the role-play simulation.	Change from baseline to immediately after the intervention