Standardized Patients to Measure and Address Intersectional Stigma

Standardized Patients to Measure and Address Intersectional Stigma: An HIV Prevention Engagement Strategy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04896216

Enrollment

Registered

2021-05-21

Start date

2020-11-24

Completion date

2022-09-30

Last updated

2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, Hiv, HIV Infections

Keywords

stigma

Brief summary

This study aims to develop and evaluate an intervention to reduce enacted stigma in healthcare settings aimed at people living with HIV (PLWH) and men who have sex with men (MSM) in China. Enacted stigma will be measured using a quality of care score collected through unannounced standardized patient (SP) visits to consenting providers in sexual health clinics.

Detailed description

Standardized patients, or trained actors from the community, will conduct a baseline round of unannounced clinic visits with consenting providers for the purposes of observing their clinical performance. SPs will present clinically standardized case scenarios, but the HIV status and sexual orientation of each case will be randomly varied in order to quantify the extent to which HIV stigma and/or homophobia contribute to the deterioration of care quality. Care quality will be calculated using a global score based on a standard checklist administered to SPs following each visit. Results of the baseline visit will inform the development of a stigma reduction intervention for consenting providers employed at clinics randomized to the treatment arm of the study. Design of this intervention has been informed by results of the baseline study and incorporates expert input from members of community advisory boards (CAB), one made up of community members and the other of providers. The intervention will consist of both didactic and skills-building methods and will be delivered both in-person and through follow-up modules online. Didactic portions will include content on topics including clinical management of common STIs, shared decision making, sexual history taking, and working with marginalized populations. Skills-building sessions will include group-based discussion and medical simulation and feedback with trained standardized patients. Follow-up data collection will begin within 2 months of completing the stigma reduction intervention using the same approach as for the baseline data collection. All research activities will take place in Guangzhou, China.

Interventions

BEHAVIORALStigma Reduction Intervention

Care providers will complete the Stigma Reduction Intervention curriculum. This study uses a modified Zelen design. Control arm participants will be aware that they are part of an observational study but not that they are in the control arm of an intervention study. This avoids artificially inducing changes to the standards of medical care in facilities randomization to the control arm, a common consequence in RCTs to evaluate population based services.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Eligible facilities will be those with: 1. formal government accreditation as a medical center (a basic tenet of all public hospitals in China); and 2. possession of an accredited on-site laboratory with capacity to provide enzyme-linked immunosorbent assay testing for HIV, treponemal (e.g. Treponema pallidum particle agglutination) and non-treponemal tests (e.g. rapid plasma regain) for syphilis. * Within eligible and consenting facilities, eligible providers will be those who are licensed at the time of the study to practice dermatovenereology in China.

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
MSM Stigma; Domain of Care: Syphilis Testing	4 months post-intervention	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.
HIV Stigma; Domain of Care: Syphilis Testing	4 months post-intervention	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 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.
Intersectional Stigma; Domain of Care: Syphilis Testing	4 months post-intervention	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 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.
MSM Stigma; Domain of Care: Diagnostic Effort	4 months post-intervention	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 the level of diagnostic effort expended by the doctor.
HIV Stigma; Domain of Care: Diagnostic Effort	4 months post-intervention	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 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.
Intersectional Stigma; Domain of Care: Diagnostic Effort	4 months post-intervention	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 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.
MSM Stigma; Domain of Care: Patient-centered Care	4 months post-intervention	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 the patient-centeredness of care provided.
HIV Stigma; Domain of Care: Patient-centered Care	4 months post-intervention	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 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.
Intersectional Stigma; Domain of Care: Patient-centered Care	4 months post-intervention	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 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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
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)	30
Control Standard of care (i.e. no training intervention)	25
Total	55

Baseline characteristics

Characteristic	Control	Total	Stigma Reduction Intervention
Age, Continuous	43 years STANDARD_DEVIATION 9	42 years STANDARD_DEVIATION 9	40 years STANDARD_DEVIATION 9
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	25 Participants	55 Participants	30 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	10 Participants	21 Participants	11 Participants
Sex: Female, Male Male	15 Participants	34 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 25
other Total, other adverse events	0 / 30	0 / 25
serious Total, serious adverse events	0 / 30	0 / 25

Outcome results

Primary

HIV Stigma; Domain of Care: Diagnostic Effort

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 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.