Standardized Patients to Measure and Address Intersectional Stigma

University of Minnesota (UMN)

Status: Completed

Conditions: AIDS; HIV Infections; Hiv

Treatments: Behavioral: Stigma Reduction Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04896216

R34MH121251 (U.S. NIH Grant/Contract)

STUDY00006470

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Stigma Reduction Intervention

Experimental group

Description:

A Stigma Reduction Intervention curriculum developed using data generated from Stage 1 of the study. For stage 2/intervention stage, participants who are providers and randomized to the "Stigma Reduction Intervention" arm through clinic-level randomization

Treatment:

Behavioral: Stigma Reduction Intervention

Control

No Intervention group

Description:

For stage 2/intervention stage, participants who are providers and randomized to the "Control" arm through clinic-level randomization