Standardized Patients to Measure and Address Intersectional Stigma

NCT04896216 | Completed Results

• 2 other identifiers: STUDY00006470R34MH121251
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hiv; HIV Infections; AIDS

Keywords

stigma

Outcome Measures

Primary Outcomes (9)

• MSM Stigma; Domain of Care: Syphilis Testing

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. 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. 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. This outcome quantifies pre-post changes in MSM stigma within each arm (i.e. differences in care quality between men who have sex with men \[MSM\] vs. straight men). This outcome measures care quality related to whether or not doctors offered a syphilis test.

  4 months post-intervention

• HIV Stigma; Domain of Care: Syphilis Testing

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. 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. 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. This outcome quantifies pre-post changes in HIV stigma within each arm (i.e. differences in care quality between HIV positive vs. HIV negative people). This outcome measures care quality related to whether or not doctors offered a syphilis test.

  4 months post-intervention

• Intersectional Stigma; Domain of Care: Syphilis Testing

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. 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. 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. This outcome quantifies pre-post changes in intersectional stigma within each arm (i.e. differences in care quality between HIV positive MSM vs. HIV negative straight men). This outcome measures care quality related to whether or not doctors offered a syphilis test.

  4 months post-intervention

• MSM Stigma; Domain of Care: Diagnostic Effort

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. 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. 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. This outcome quantifies pre-post changes in MSM stigma within each arm (i.e. differences in care quality between men who have sex with men \[MSM\] vs. straight men). This outcome measures care quality related to the level of diagnostic effort expended by the doctor.

  4 months post-intervention

• HIV Stigma; Domain of Care: Diagnostic Effort

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. 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. 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. This outcome quantifies pre-post changes in HIV stigma within each arm (i.e. differences in care quality between HIV positive vs. HIV negative people). This outcome measures care quality related to the level of diagnostic effort expended by the doctor.

  4 months post-intervention

• Intersectional Stigma; Domain of Care: Diagnostic Effort

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. 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. 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. This outcome quantifies pre-post changes in intersectional stigma within each arm (i.e. differences in care quality between HIV positive MSM vs. HIV negative straight men). This outcome measures care quality related to the level of diagnostic effort expended by the doctor.

  4 months post-intervention

• MSM Stigma; Domain of Care: Patient-centered Care

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. 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. 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. This outcome quantifies pre-post changes in MSM stigma within each arm (i.e. differences in care quality between men who have sex with men \[MSM\] vs. straight men). This outcome measures care quality related to the patient-centeredness of care provided.

  4 months post-intervention

• HIV Stigma; Domain of Care: Patient-centered Care

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. 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. 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. This outcome quantifies pre-post changes in HIV stigma within each arm (i.e. differences in care quality between HIV positive vs. HIV negative people). This outcome measures care quality related to the patient-centeredness of care provided.

  4 months post-intervention

• Intersectional Stigma; Domain of Care: Patient-centered Care

  The outcome represents the amount by which stigma was reduced in each arm between baseline and follow-up. 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. 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. This outcome quantifies pre-post changes in intersectional stigma within each arm (i.e. differences in care quality between HIV positive MSM vs. HIV negative straight men). This outcome measures care quality related to the patient-centeredness of care provided.

  4 months post-intervention

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. This study uses a modified Zelen design. Control arm participants will be aware that they are part of an observational study but not that they are in the control arm of an intervention study. This avoids artificially inducing changes to the standards of medical care in facilities randomization to the control arm, a common consequence in RCTs to evaluate population based services.

Stigma Reduction Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible facilities will be 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 will be those who are licensed at the time of the study to practice dermatovenereology in China.

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; HIV Infections; Social Stigma

Condition Hierarchy (Ancestors)

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; Social Behavior; Behavior

Results Point of Contact

• Title: Kumi Smith
• Organization: University of Minnesota

smi00831@umn.edu

612.301.3051

Study Officials

• Kumi Smith, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: May 17, 2021
• First Posted: May 21, 2021
• Study Start: November 24, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Locations

US (1)