Trial Outcomes & Findings for HIV Provider Intervention to Address Intersectional Stigma and Medical Mistrust (NCT NCT05803720)
NCT ID: NCT05803720
Last Updated: 2025-12-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
Baseline, 2-monts after the baseline assessment, and 6-month follow-up
Results posted on
2025-12-23
Participant Flow
Participant milestones
| Measure |
Provider Training Group
Providers in the training intervention group participated in a multi-component educational program designed to improve communication with patients experiencing intersectional stigma and medical mistrust in HIV care. The training included three parts: (1) a 30-40 minute pre-recorded video introducing key concepts, supported by patient narratives and research evidence; (2) a 60-minute live virtual session led by faculty from the California Prevention Training Center, featuring interactive discussion and role-play exercises to practice communication strategies; and (3) a downloadable self-paced workbook with case scenarios and reflection prompts. The intervention aimed to build provider skills in recognizing and addressing patient mistrust and stigma using respectful, autonomy-supportive communication techniques. Participants completed assessments at baseline, immediately post-training, and at 6-month follow-up.
|
No Training Control Group
Providers in the control group did not receive any training during the study period. They completed study assessments at baseline, immediately post-intervention (parallel to the intervention group's timeline), and at 6-month follow-up. After study completion, they were offered access to the training materials for ethical and educational purposes.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
Received the allocated intervention
|
27
|
28
|
|
Overall Study
Completed post assessment
|
25
|
23
|
|
Overall Study
Completed 6-month assessment
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Provider Training Group
Providers in the training intervention group participated in a multi-component educational program designed to improve communication with patients experiencing intersectional stigma and medical mistrust in HIV care. The training included three parts: (1) a 30-40 minute pre-recorded video introducing key concepts, supported by patient narratives and research evidence; (2) a 60-minute live virtual session led by faculty from the California Prevention Training Center, featuring interactive discussion and role-play exercises to practice communication strategies; and (3) a downloadable self-paced workbook with case scenarios and reflection prompts. The intervention aimed to build provider skills in recognizing and addressing patient mistrust and stigma using respectful, autonomy-supportive communication techniques. Participants completed assessments at baseline, immediately post-training, and at 6-month follow-up.
|
No Training Control Group
Providers in the control group did not receive any training during the study period. They completed study assessments at baseline, immediately post-intervention (parallel to the intervention group's timeline), and at 6-month follow-up. After study completion, they were offered access to the training materials for ethical and educational purposes.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Family leave/emergency
|
1
|
1
|
Baseline Characteristics
2 participants in the control condition did not complete demographic information (i.e., missing data on age)
Baseline characteristics by cohort
| Measure |
Provider Training Group
n=29 Participants
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.
|
Control Group
n=30 Participants
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.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 13.72 • n=29 Participants • 2 participants in the control condition did not complete demographic information (i.e., missing data on age)
|
42.82 years
STANDARD_DEVIATION 10.58 • n=28 Participants • 2 participants in the control condition did not complete demographic information (i.e., missing data on age)
|
42.61 years
STANDARD_DEVIATION 12.17 • n=57 Participants • 2 participants in the control condition did not complete demographic information (i.e., missing data on age)
|
|
Sex/Gender, Customized
Male
|
8 Participants
n=29 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
8 Participants
n=28 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
16 Participants
n=57 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
|
Sex/Gender, Customized
Female
|
18 Participants
n=29 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
17 Participants
n=28 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
35 Participants
n=57 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
|
Sex/Gender, Customized
Man, Female-to-Man (FTM)
|
1 Participants
n=29 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
2 Participants
n=28 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
3 Participants
n=57 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
|
Sex/Gender, Customized
Prefer not to answer
|
2 Participants
n=29 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
1 Participants
n=28 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
3 Participants
n=57 Participants • Measure Analysis Population Description: 2 participants in the control condition did not complete demographic information (i.e., missing data on gender identification)
|
|
Sex: Female, Male
Female
|
18 Participants
n=26 Participants • Training group: 1 identified as Man (female to man, 2 prefer not to answer Control group: 2 identifies as Man (female to man), 1 prefer not to answer, also 2 missing this variable in baseline survey.
|
17 Participants
n=25 Participants • Training group: 1 identified as Man (female to man, 2 prefer not to answer Control group: 2 identifies as Man (female to man), 1 prefer not to answer, also 2 missing this variable in baseline survey.
|
35 Participants
n=51 Participants • Training group: 1 identified as Man (female to man, 2 prefer not to answer Control group: 2 identifies as Man (female to man), 1 prefer not to answer, also 2 missing this variable in baseline survey.
|
|
Sex: Female, Male
Male
|
8 Participants
n=26 Participants • Training group: 1 identified as Man (female to man, 2 prefer not to answer Control group: 2 identifies as Man (female to man), 1 prefer not to answer, also 2 missing this variable in baseline survey.
|
8 Participants
n=25 Participants • Training group: 1 identified as Man (female to man, 2 prefer not to answer Control group: 2 identifies as Man (female to man), 1 prefer not to answer, also 2 missing this variable in baseline survey.
|
16 Participants
n=51 Participants • Training group: 1 identified as Man (female to man, 2 prefer not to answer Control group: 2 identifies as Man (female to man), 1 prefer not to answer, also 2 missing this variable in baseline survey.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=29 Participants
|
5 Participants
n=30 Participants
|
8 Participants
n=59 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=29 Participants
|
23 Participants
n=30 Participants
|
49 Participants
n=59 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=59 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=59 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=29 Participants
|
1 Participants
n=30 Participants
|
5 Participants
n=59 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=59 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=29 Participants
|
9 Participants
n=30 Participants
|
15 Participants
n=59 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=29 Participants
|
13 Participants
n=30 Participants
|
29 Participants
n=59 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=29 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=59 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=29 Participants
|
6 Participants
n=30 Participants
|
7 Participants
n=59 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
30 participants
n=30 Participants
|
59 participants
n=59 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2-monts after the baseline assessment, and 6-month follow-upPopulation: Participants dropped out or cannot be reached after baseline assessment.
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.
Outcome measures
| Measure |
Provider Training Group
n=29 Participants
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.
|
Control Group
n=30 Participants
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.
|
|---|---|---|
|
Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios
Baseline
|
9.81 score on a scale
Standard Deviation 2.60
|
9.26 score on a scale
Standard Deviation 1.75
|
|
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
|
8.90 score on a scale
Standard Deviation 2.05
|
|
Helpful/Empathetic Responses Toward Medial Mistrust in Hypothetical Patient Scenarios
6-month follow-up
|
9.29 score on a scale
Standard Deviation 2.94
|
9.16 score on a scale
Standard Deviation 2.13
|
PRIMARY outcome
Timeframe: Baseline and 2-month after the baseline assessmentPopulation: Participants dropped out or cannot be reached after 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.
Outcome measures
| Measure |
Provider Training Group
n=29 Participants
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.
|
Control Group
n=30 Participants
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.
|
|---|---|---|
|
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
|
7.94 score on a scale
Standard Deviation 2.37
|
|
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
|
7.56 score on a scale
Standard Deviation 2.30
|
PRIMARY outcome
Timeframe: Baseline and 2-month after the baseline assessmentPopulation: Participants dropped out or cannot be reached after 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-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.
Outcome measures
| Measure |
Provider Training Group
n=29 Participants
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.
|
Control Group
n=30 Participants
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.
|
|---|---|---|
|
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
|
0.67 score on a scale
Standard Deviation 0.78
|
|
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
|
0.53 score on a scale
Standard Deviation 0.47
|
Adverse Events
Provider Training Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place