Stigma, Social
Conditions
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.
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.
Interventions
BEHAVIORALProvider 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.
Sponsors
California Prevention Training Center
Brigham and Women's Hospital
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blind to the study condition assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios | Baseline, 2-monts after the baseline assessment, and 6-month follow-up | 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. |
| Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios | Baseline and 2-month after the baseline assessment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Provider Training Group Participants received a three-part training on addressing medical mistrust and intersectional stigma in HIV care. The training included a 1-hour recorded module, a 2-hour live role-play session, and a self-paced workbook. Content focused on using validation and motivational interviewing strategies to improve provider communication. | 29 |
| Control Group Participants in the control group did not receive any training during the study period. They completed the same baseline, post, and follow-up assessments as the intervention group for comparison purposes. | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Family leave/emergency | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 4 |
Baseline characteristics
| Characteristic | Total | Provider Training Group | Control Group |
|---|---|---|---|
| Age, Continuous | 42.61 years STANDARD_DEVIATION 12.17 | 42.4 years STANDARD_DEVIATION 13.72 | 42.82 years STANDARD_DEVIATION 10.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 26 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 29 Participants | 16 Participants | 13 Participants |
| Region of Enrollment United States | 59 participants | 29 participants | 30 participants |
| Sex: Female, Male Female | 35 Participants | 18 Participants | 17 Participants |
| Sex: Female, Male Male | 16 Participants | 8 Participants | 8 Participants |
| Sex/Gender, Customized Female | 35 Participants | 18 Participants | 17 Participants |
| Sex/Gender, Customized Male | 16 Participants | 8 Participants | 8 Participants |
| Sex/Gender, Customized Man, Female-to-Man (FTM) | 3 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Prefer not to answer | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
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. This measure is a count variable and the values ranging above or equal to 0 (no maximum). Higher values represent a better outcome.
Time frame: Baseline, 2-monts after the baseline assessment, and 6-month follow-up
Population: Participants dropped out or cannot be reached after baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Provider Training Group | Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios | Baseline | 9.81 score on a scale | Standard Deviation 2.6 |
| Provider Training Group | Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios | 6-month follow-up | 9.29 score on a scale | Standard Deviation 2.94 |
| Provider Training Group | Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios | 2-month after the baseline assessment | 10.68 score on a scale | Standard Deviation 3.99 |
| Control Group | Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios | Baseline | 9.26 score on a scale | Standard Deviation 1.75 |
| Control Group | Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios | 2-month after the baseline assessment | 8.90 score on a scale | Standard Deviation 2.05 |
| Control Group | Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios | 6-month follow-up | 9.16 score on a scale | Standard Deviation 2.13 |
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 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.
Time frame: Baseline and 2-month after the baseline assessment
Population: Participants dropped out or cannot be reached after baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Provider Training Group | Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios | Training-consistent codes at Baseline | 8.04 score on a scale | Standard Deviation 2.96 |
| Provider Training Group | Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios | Training-consistent codes at Post (2 months after baseline assessment) | 8.60 score on a scale | Standard Deviation 3.07 |
| Control Group | Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios | Training-consistent codes at Baseline | 7.94 score on a scale | Standard Deviation 2.37 |
| Control Group | Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios | Training-consistent codes at Post (2 months after baseline assessment) | 7.56 score on a scale | Standard Deviation 2.3 |
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 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.
Time frame: Baseline and 2-month after the baseline assessment
Population: Participants dropped out or cannot be reached after baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Provider Training Group | Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios | Training-inconsistent codes at Baseline | 0.33 score on a scale | Standard Deviation 0.54 |
| Provider Training Group | Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios | Training-inconsistent codes at Post (2 months after baseline assessment) | 0.29 score on a scale | Standard Deviation 0.51 |
| Control Group | Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios | Training-inconsistent codes at Post (2 months after baseline assessment) | 0.53 score on a scale | Standard Deviation 0.47 |
| Control Group | Provider Use of Strategies Learned in the Provider Intervention in a Role-play Simulation of Hypothetical Patient Scenarios | Training-inconsistent codes at Baseline | 0.67 score on a scale | Standard Deviation 0.78 |