Clinical trial NCT06975176: Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach
Official title: Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Impact of the intervention on healthcare stigma directed at men who have sex with men (i.e. homophobia) in which stigma is measured as differences in whether or not syphilis testing was offered to MSM vs straight patients.
timeFrame: 3 months
measure: Impact of the intervention on healthcare stigma directed at people living with HIV (i.e. HIV stigma), in which stigma is measured as differences in whether or not syphilis testing was offered to patients living with HIV vs those not living with HIV.
timeFrame: 3 months
measure: Impact of the intervention on healthcare stigma directed at people living with HIV who are also MSM (i.e. intersectional stigma), measured as differences in whether syphilis testing was offered to MSM with HIV vs. straight men without HIV.
timeFrame: 3 months
measure: Impact of the intervention on healthcare stigma directed at men who have sex with men (i.e. homophobia), in which stigma is measured as differences in the level of diagnostic effort expended by doctors for MSM patients vs straight patients.
timeFrame: 3 months
measure: Impact of the intervention on healthcare stigma directed at people living with HIV (HIV stigma), in which stigma is measured as differences in diagnostic effort expended by doctors for patients living with HIV vs. patients not living with HIV.
timeFrame: 3 months
measure: Impact of the intervention on healthcare stigma directed at people living with HIV and who are MSM (i.e. intersectional stigma), in which stigma is measured as differences in diagnostic effort by doctors for MSM with HIV vs. straight men without HIV.
timeFrame: 3 months
measure: Impact of the intervention on healthcare stigma directed at men who have sex with men (homophobia), in which stigma is measured as differences in the patient-centeredness of care provided to MSM vs. straight patients.
timeFrame: 3 months
measure: Impact of the intervention on healthcare stigma directed at people living with HIV (HIV stigma), in which stigma is measured as differences in the patient-centeredness of care provided to patients living with HIV vs. those not living with HIV.
timeFrame: 3 months
measure: Impact of the intervention on healthcare stigma directed at people living with HIV and who are MSM (i.e. intersectional stigma), in which stigma is measured as differences in patient-centeredness of care for MSM with HIV vs. straight men without HIV.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Kumi Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: