Standardized Patients to Measure and Address Intersectional Stigma
Primary Purpose
Hiv, HIV Infections, AIDS
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stigma Reduction Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Hiv focused on measuring stigma
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stigma Reduction Intervention
Control
Arm Description
A Stigma Reduction Intervention curriculum will be developed using data generated from Stage 1 of the study.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04896216
Brief Title
Standardized Patients to Measure and Address Intersectional Stigma
Official Title
Standardized Patients to Measure and Address Intersectional Stigma: An HIV Prevention Engagement Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, HIV Infections, AIDS
Keywords
stigma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stigma Reduction Intervention
Arm Type
Experimental
Arm Description
A Stigma Reduction Intervention curriculum will be developed using data generated from Stage 1 of the study.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stigma Reduction Intervention
Intervention Description
Care providers will complete the Stigma Reduction Intervention curriculum.
Primary Outcome Measure Information:
Title
Quality of Medical Care Questionnaire
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HIV Testing Volume
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kumi Smith, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Standardized Patients to Measure and Address Intersectional Stigma
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