Combating HIV Stigma in Healthcare Settings - A Standardized Patient Approach: Protocol Paper for a Randomized Controlled Trial (Preprint)

BACKGROUND Healthcare stigma remains one of the most persistent barriers to uptake of HIV services, particularly among sexual minorities including gay, bisexual, and other men who have sex with men (MSM). A major challenge in combating healthcare stigma is the inherent challenge of objective measurement which limits researchers’ ability to observe the very behaviors they seek to change. We have pioneered the use of unannounced visits by standardized patients (SP) to measure healthcare stigma. SPs are trained actors who present standardized disease cases to consenting providers. By randomly varying the HIV status and sexual orientation of SP case presentations, this method can be used to quantify healthcare stigma as average differences in care quality received across all case presentations. OBJECTIVE This study aims to use standardized patients to evaluate a training program for clinicians to reduce stigma faced by MSM and people living with HIV (PLWH) in healthcare settings in Vietnam, where healthcare stigma has been well documented. METHODS This cluster randomized controlled trial (RCT) will be conducted in health facilities providing sexual health services. Facilities will be randomized to either a stigma reduction intervention informed by the Information-Motivation-Behavioral Skills model or the standard of care. Study participants are medical providers (n=155) working at eligible health facilities. Findings from a baseline round of SP visits will be used to refine the intervention training, which will then be evaluated for effectiveness using a follow-up round of SP visits. Visits are only conducted with consenting providers, but they are not told about visit timing or case details. The three primary outcomes – 1) MSM stigma (i.e. homophobia), 2) HIV stigma, and 3) intersectional stigma – are conceptualized as the average difference in healthcare quality received in each test case (HIV-negative MSM; HIV-positive MSM; HIV-positive straight man) as compared to the referent scenario (HIV-negative straight man). SP visit data will be collected via Qualtrics and analyzed using intent-to-treat (ITT) and ordinary least squares linear regression models. Secondary outcomes will be informed by qualitative interviews with providers and stakeholders, which will be analyzed using thematic analysis. RESULTS Recruitment of study participants is planned to begin in Quarter 4, 2026. Study data collection and all SP visits will be completed by Quarter 4, 2028. CONCLUSIONS Study findings will provide critical evidence on the effectiveness of a stigma reduction intervention informed by direct audits of provider behaviors. If found feasible and effective in Vietnamese clinical settings, the intervention may provide a scalable model for stigma reduction nationwide and beyond. Our study also addresses longstanding challenges in the rigorous evaluation of stigma interventions by using an objective measure of healthcare stigma. CLINICALTRIAL This study is registered in ClinicalTrials.gov Study #: NCT06975176.