Trial Outcomes & Findings for Standardized Patients to Measure and Address Intersectional Stigma (NCT NCT04896216)
NCT ID: NCT04896216
Last Updated: 2024-07-31
Results Overview
The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in MSM stigma within each arm (i.e. differences in care quality between men who have sex with men \[MSM\] vs. straight men). This outcome measures care quality related to whether or not doctors offered a syphilis test.
COMPLETED
NA
59 participants
4 months post-intervention
2024-07-31
Participant Flow
The study consisted of a baseline study visit, after which treatment arm providers received the training intervention. After the intervention, a follow-up visit was conducted for evaluation purposes. Randomization procedures were conducted at baseline.
Unit of analysis: clinics
Participant milestones
| Measure |
Stigma Reduction Intervention
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
Overall Study
STARTED
|
30 9
|
29 8
|
|
Overall Study
COMPLETED
|
27 9
|
18 7
|
|
Overall Study
NOT COMPLETED
|
3 0
|
11 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Standardized Patients to Measure and Address Intersectional Stigma
Baseline characteristics by cohort
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 9 • n=99 Participants
|
43 years
STANDARD_DEVIATION 9 • n=107 Participants
|
42 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in MSM stigma within each arm (i.e. differences in care quality between men who have sex with men \[MSM\] vs. straight men). This outcome measures care quality related to whether or not doctors offered a syphilis test.
Outcome measures
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
MSM Stigma; Domain of Care: Syphilis Testing
|
0.078 percentage points
Interval -0.079 to 0.235
|
0.034 percentage points
Interval -0.181 to 0.248
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in HIV stigma within each arm (i.e. differences in care quality between HIV positive vs. HIV negative people). This outcome measures care quality related to whether or not doctors offered a syphilis test.
Outcome measures
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
HIV Stigma; Domain of Care: Syphilis Testing
|
-0.201 percentage points
Interval -0.406 to 0.005
|
0.034 percentage points
Interval -0.181 to 0.248
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in intersectional stigma within each arm (i.e. differences in care quality between HIV positive MSM vs. HIV negative straight men). This outcome measures care quality related to whether or not doctors offered a syphilis test.
Outcome measures
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
Intersectional Stigma; Domain of Care: Syphilis Testing
|
-0.07 percentage points
Interval -0.38 to 0.25
|
0 percentage points
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in MSM stigma within each arm (i.e. differences in care quality between men who have sex with men \[MSM\] vs. straight men). This outcome measures care quality related to the level of diagnostic effort expended by the doctor.
Outcome measures
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
MSM Stigma; Domain of Care: Diagnostic Effort
|
-0.055 percentage points
Interval -0.862 to 0.752
|
0.396 percentage points
Interval -0.278 to 1.069
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in HIV stigma within each arm (i.e. differences in care quality between HIV positive vs. HIV negative people). This outcome measures care quality related to the level of diagnostic effort expended by the doctor.
Outcome measures
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
HIV Stigma; Domain of Care: Diagnostic Effort
|
-0.570 percentage points
Interval -1.23 to 0.09
|
0.396 percentage points
Interval -0.278 to 1.069
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in intersectional stigma within each arm (i.e. differences in care quality between HIV positive MSM vs. HIV negative straight men). This outcome measures care quality related to the level of diagnostic effort expended by the doctor.
Outcome measures
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
Intersectional Stigma; Domain of Care: Diagnostic Effort
|
0.621 percentage points
Interval -0.237 to 1.478
|
0.396 percentage points
Interval -0.278 to 1.069
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in MSM stigma within each arm (i.e. differences in care quality between men who have sex with men \[MSM\] vs. straight men). This outcome measures care quality related to the patient-centeredness of care provided.
Outcome measures
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
MSM Stigma; Domain of Care: Patient-centered Care
|
-0.168 percentage points
Interval -0.595 to 0.259
|
-0.162 percentage points
Interval -0.852 to 0.528
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in HIV stigma within each arm (i.e. differences in care quality between HIV positive vs. HIV negative people). This outcome measures care quality related to the patient-centeredness of care provided.
Outcome measures
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
HIV Stigma; Domain of Care: Patient-centered Care
|
0.408 percentage points
Interval -0.31 to 1.126
|
-0.162 percentage points
Interval -0.852 to 0.528
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. This outcome quantifies pre-post changes in intersectional stigma within each arm (i.e. differences in care quality between HIV positive MSM vs. HIV negative straight men). This outcome measures care quality related to the patient-centeredness of care provided.
Outcome measures
| Measure |
Stigma Reduction Intervention
n=30 Participants
Experimental: a stigma reducation training intervention for providers employed at clinics randomized to the intervention arm.
No intervention: standard of care (i.e. no training intervention)
|
Control
n=25 Participants
Standard of care (i.e. no training intervention)
|
|---|---|---|
|
Intersectional Stigma; Domain of Care: Patient-centered Care
|
-0.165 percentage points
Interval -0.836 to 0.506
|
-0.162 percentage points
Interval -0.852 to 0.528
|
Adverse Events
Stigma Reduction Intervention
Control
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