Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach

NCT ID: NCT06975176

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-07
• Study Completion Date: 2028-10-31

Brief Summary

The goal of this study is to develop and evaluate the effectiveness of a training program to reduce intersectional stigma faced by sexual minorities and people living with HIV (PLWH) in healthcare settings. The study participants are medical providers (i.e. physicians) specializing in sexual health medicine in China.

Detailed Description

Consistent data highlight the central role of stigma in limiting uptake of HIV related testing, treatment, and care. This is particularly true for gay, bisexual, and other MSM who have the lowest rates of engagement with the healthcare system despite bearing the highest HIV incidence burden. Particularly for MSM seeking HIV testing services, enacted stigma-overt acts of discrimination and hostility directed at a person because of their perceived stigmatized status -both on account of their same-sex behaviors (i.e. sexuality stigma or homophobia) and the perception of their elevated HIV risk (HIV stigma) is all too common. Trained standardized patients (SP) will present a standardized case to providers.

SPs will present clinically standardized case scenarios, but the HIV status and sexual orientation of each case will be randomly varied. Stigma will be evaluated by comparing the quality of care that SPs experience during provider visits. Results of the baseline visit will inform the development of a stigma reduction training program for provider participants employed at clinics randomized to the treatment arm. The overall structure consists of didactic content as well as experiential learning using simulation-and-feedback sessions with trained SPs.

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Stigma Reduction Intervention

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

Group Type: EXPERIMENTAL

Stigma reduction intervention

Intervention Type: BEHAVIORAL

Care providers will complete the Stigma Reduction Intervention curriculum. The intervention is a multi-day stigma reduction training program for providers.

Content design is greatly informed by materials developed in our pilot R34 study, and which may be modified prior to the intervention if the team gains new insights from the baseline round of unannounced visits and each of the two CABs. Briefly, the intervention consists of both didactic and experiential learning components. Didactic sessions include instruction on syphilis epidemiology, clinical management, and public health significance. Experiential sessions include discussion sessions that are facilitated by pre-recorded videos, followed by role play with trained SPs.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stigma reduction intervention

Care providers will complete the Stigma Reduction Intervention curriculum. The intervention is a multi-day stigma reduction training program for providers.

Content design is greatly informed by materials developed in our pilot R34 study, and which may be modified prior to the intervention if the team gains new insights from the baseline round of unannounced visits and each of the two CABs. Briefly, the intervention consists of both didactic and experiential learning components. Didactic sessions include instruction on syphilis epidemiology, clinical management, and public health significance. Experiential sessions include discussion sessions that are facilitated by pre-recorded videos, followed by role play with trained SPs.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Eligible facilities are 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 are those who are licensed at the time of the study to practice STD care in China.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kumi Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sophie Watson

Role: CONTACT

watso684@umn.edu

612-301-3051

Facility Contacts

Sophie Watson

Role: primary

watso684@umn.edu

612-301-3051

Other Identifiers

HIV Stigma

Identifier Type: -

Identifier Source: org_study_id