Standardized Patients to Measure and Address Intersectional Stigma

July 29, 2024 updated by: University of Minnesota

Standardized Patients to Measure and Address Intersectional Stigma: An HIV Prevention Engagement Strategy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Standardized patients, or trained actors from the community, will conduct a baseline round of unannounced clinic visits with consenting providers for the purposes of observing their clinical performance. SPs will present clinically standardized case scenarios, but the HIV status and sexual orientation of each case will be randomly varied in order to quantify the extent to which HIV stigma and/or homophobia contribute to the deterioration of care quality. Care quality will be calculated using a global score based on a standard checklist administered to SPs following each visit. Results of the baseline visit will inform the development of a stigma reduction intervention for consenting providers employed at clinics randomized to the treatment arm of the study. Design of this intervention has been informed by results of the baseline study and incorporates expert input from members of community advisory boards (CAB), one made up of community members and the other of providers. The intervention will consist of both didactic and skills-building methods and will be delivered both in-person and through follow-up modules online. Didactic portions will include content on topics including clinical management of common STIs, shared decision making, sexual history taking, and working with marginalized populations. Skills-building sessions will include group-based discussion and medical simulation and feedback with trained standardized patients. Follow-up data collection will begin within 2 months of completing the stigma reduction intervention using the same approach as for the baseline data collection. All research activities will take place in Guangzhou, China.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible facilities will be those with:

    1. formal government accreditation as a medical center (a basic tenet of all public hospitals in China); and
    2. 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.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Behavioral: Stigma Reduction Intervention
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.
No Intervention: Control
For stage 2/intervention stage, participants who are providers and randomized to the "Control" arm through clinic-level randomization

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MSM Stigma; Domain of Care: Syphilis Testing
Time Frame: 4 months post-intervention
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
Time Frame: 4 months post-intervention
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
Time Frame: 4 months post-intervention
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
Time Frame: 4 months post-intervention
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
Time Frame: 4 months post-intervention
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
Time Frame: 4 months post-intervention
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
Time Frame: 4 months post-intervention
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
Time Frame: 4 months post-intervention
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
Time Frame: 4 months post-intervention
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HIV Testing Volume
Time Frame: 12 months
The secondary outcome is HIV testing volume, which will be reported as the aggregate clinic-level number of HIV tests conducted in each enrolled clinic during the study period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kumi Smith, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00006470
  • R34MH121251 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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