Standardized Patients to Measure and Address Intersectional Stigma

Study Overview
=================
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.

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

Conditions
-----------------
Hiv, HIV Infections, AIDS

Intervention / Treatment
-----------------
* Behavioral: Stigma Reduction Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible facilities will be those with: formal government accreditation as a medical center (a basic tenet of all public hospitals in China); and 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stigma Reduction Intervention<br>A Stigma Reduction Intervention curriculum will be developed using data generated from Stage 1 of the study. | Behavioral: Stigma Reduction Intervention<br>* Care providers will complete the Stigma Reduction Intervention curriculum.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Medical Care Questionnaire | The primary outcome is a scale reflecting the quality of medical care provided by physicians to unannounced standardized patients (SPs) presenting with cases of presumed syphilis. The quality of care in these interactions will be measured using 38 items from a survey questionnaire administered to SPs following each unannounced visit. Individual items will be combined into a global index, which is calculated as a weighted average of all 38 items. Scores are standardized and range from negative to positive infinity, with higher scores indicating better quality medical care. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Testing Volume | The secondary outcome is HIV testing volume, which will be reported as the aggregate clinic-level number of HIV tests conducted in each enrolled clinic during the study period. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stigma