Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach

NCT06975176 | Not Yet Recruiting

• 1 other identifier: HIV Stigma
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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 Vietnam.

Conditions

Hiv

Outcome Measures

Primary Outcomes (9)

• 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.

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. This outcome compares pre-post changes in MSM stigma across study arms (i.e. differences in care quality between men who have sex with men \[MSM\] vs. straight men). This particular outcome measures care quality in terms of whether or not doctors offered a syphilis test.

  3 months

• 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.

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. This outcome compares pre-post changes in HIV stigma across study arms (i.e. differences in care quality between people living with HIV \[PLWH\] vs. those who are not living with HIV). This particular outcome measures care quality in terms of whether or not doctors offered a syphilis test.

  3 months

• 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.

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. This outcome compares pre-post changes in intersectional stigma across study arms (i.e. differences in care quality between MSM living with HIV vs. straight men not living with HIV). This outcome measures care quality related to whether or not doctors offered a syphilis test. This particular outcome measures care quality in terms of whether or not doctors offered a syphilis test.

  3 months

• 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.

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. Stigma itself was measured as the difference in healthcare quality between a stigmatized group vs. a dominant group. Because healthcare is multidimensional, we examined it across three domains: syphilis testing, diagnostic effort, and patient-centeredness of care. Positive values mean stigma indicate a decrease in stigma between the two time points. Negative values mean an increase in stigma between the two time points. This outcome compares pre-post changes in MSM stigma across study arms (i.e. differences in care quality between men who have sex with men \[MSM\] vs. straight men). This particular outcome measures care quality in terms of the level of diagnostic effort expended. Our measure of diagnostic effort is a composite indicator constructed from 18 items relating to various aspects of diagnostic care such as history taking and physical examinations.

  3 months

• 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.

  The outcome reflects the amount by which stigma was reduced in each arm between baseline and follow-up. Stigma was measured as the difference in healthcare quality between stigmatized and dominant groups. Because healthcare is multidimensional, we examined three domains: syphilis testing, diagnostic effort, and patient-centeredness. Positive values indicate decreased stigma; negative values indicate increased stigma. This outcome compares pre-post changes in HIV stigma across study arms (i.e. differences in care quality between people living with HIV \[PLWH\] and those not living with HIV). It measures care quality by the level of diagnostic effort. Diagnostic effort is a composite indicator based on 18 items on history taking, physical exams, and other aspects of care. The scale was developed by the study team using Chinese clinical guidelines and input from local physicians experienced in person-centered sexual health care. Items use 4-point Likert scales summed into a provider score.

  3 months

• 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.

  The outcome reflects how much stigma was reduced in each arm between baseline and follow-up. Stigma was measured as the difference in healthcare quality between stigmatized and dominant groups. As healthcare is multidimensional, we examined three domains: syphilis testing, diagnostic effort, and patient-centeredness. Positive values indicate a decrease in stigma between time points; negative values indicate an increase. This outcome compares pre-post changes in intersectional stigma across study arms (i.e. differences in care quality between MSM with HIV and HIV-negative straight men). It measures care quality by level of diagnostic effort. Diagnostic effort is a composite indicator based on 18 items covering history taking, physical exams, and other aspects of care. The scale was developed by the study team using Chinese clinical guidelines and input from local physicians experienced in person-centered sexual health care. Items use 4-point Likert scales, summed into a provider score.

  3 months

• 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.

  The outcome reflects how much stigma was reduced in each arm between baseline and follow-up. Stigma was measured as the difference in healthcare quality between stigmatized and dominant groups. As healthcare is multidimensional, we examined three domains: syphilis testing, diagnostic effort, and patient-centeredness. Positive values indicate a decrease in stigma between time points; negative values indicate an increase. This outcome compares pre-post changes in MSM stigma across study arms (i.e., differences in care quality between MSM and straight men). It specifically measures care quality in terms of patient-centeredness. Our measure of patient-centeredness is a composite indicator based on 19 items like doctors' word choice and use of nonverbal communication. The scale was developed by the study team using Chinese clinical guidelines and input from local physicians experienced in person-centered sexual health care. Items use 4-point Likert scales, summed into a provider score.

  3 months

• 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.

  The outcome reflects how much stigma was reduced in each arm between baseline and follow-up. Stigma was measured as the difference in healthcare quality between a stigmatized group and a dominant group. As healthcare is multidimensional, we examined three domains: syphilis testing, diagnostic effort, and patient-centeredness. Positive values indicate a decrease in stigma; negative values indicate an increase. This outcome compares pre-post changes in HIV stigma across study arms (i.e., differences in care quality between people living with HIV \[PLWH\] and those not living with HIV). It specifically measures care quality based on patient-centeredness. Our measure is a composite indicator from 19 relevant items such as doctors' word choice or nonverbal communication. The scale was developed by the study team using Chinese clinical guidelines and input from local physicians experienced in person-centered sexual health care. Items use 4-point Likert scales, summed into a provider score.

  3 months

• 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.

  The outcome reflects how much stigma was reduced in each arm between baseline and follow-up. Stigma was measured as the difference in healthcare quality between stigmatized and dominant groups. As healthcare is multidimensional, we examined three domains: syphilis testing, diagnostic effort, and patient-centeredness. Positive values indicate a decrease in stigma; negative values indicate an increase. This outcome compares pre-post changes in intersectional stigma across study arms (i.e. differences in care quality between MSM with HIV and straight men without HIV). It specifically measures care quality based on patient-centeredness. Our measure is a composite indicator constructed from 19 items such as doctors' word choice or use of nonverbal communication. The scale was developed by the study team using Chinese clinical guidelines and input from local physicians experienced in person-centered sexual health care. Items use 4-point Likert scales, summed into a provider score.

  3 months

Study Arms (2)

Stigma Reduction Intervention

EXPERIMENTAL

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

Behavioral: Stigma reduction intervention

Control

NO INTERVENTION

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

Interventions

Stigma reduction intervention 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.

Stigma Reduction Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible facilities are those with capacity to provide STDs care and treatment services. Within eligible and consenting facilities, eligible providers are those who are licensed at the time of the study to practice STD care in Vietnam.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Kumi Smith, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Watson

CONTACT

612-301-3051; watso684@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: May 16, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)