Clinical trial NCT04896216: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
HIV Infections
AIDS
Keywords: stigma
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: MSM Stigma; Domain of Care: Syphilis Testing
timeFrame: 4 months post-intervention
measure: HIV Stigma; Domain of Care: Syphilis Testing
timeFrame: 4 months post-intervention
measure: Intersectional Stigma; Domain of Care: Syphilis Testing
timeFrame: 4 months post-intervention
measure: MSM Stigma; Domain of Care: Diagnostic Effort
timeFrame: 4 months post-intervention
measure: HIV Stigma; Domain of Care: Diagnostic Effort
timeFrame: 4 months post-intervention
measure: Intersectional Stigma; Domain of Care: Diagnostic Effort
timeFrame: 4 months post-intervention
measure: MSM Stigma; Domain of Care: Patient-centered Care
timeFrame: 4 months post-intervention
measure: HIV Stigma; Domain of Care: Patient-centered Care
timeFrame: 4 months post-intervention
measure: Intersectional Stigma; Domain of Care: Patient-centered Care
timeFrame: 4 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kumi Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: