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HivNCT06975176

Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach

A study testing Stigma reduction intervention in people with Hiv, run by University of Minnesota at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Hiv
What is being tested?
Stigma reduction intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
1 siteUnited States
Study dates
7 Dec 2026to 31 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sophie Watson contact

612-301-3051

watso684@umn.edu

United States1 site
  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Sophie Watson, 612-301-3051, watso684@umn.edu

Other trials in United States

About this study

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.

Read the 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.

Conditions
Hiv
Being tested
Stigma reduction intervention
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stigma reduction interventionBehavioural

    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.

Study groups in NCT06975176
Study groupRoleWhat they receive
Stigma Reduction InterventionExperimentalA 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
Receives: Behavioral: Stigma reduction intervention
ControlNo interventionFor stage 2/intervention stage, participants who are providers and randomized to the "Control" arm through clinic-level randomization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: 3 months

  6. 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.

    Measured: 3 months

  7. 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.

    Measured: 3 months

  8. 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.

    Measured: 3 months

  9. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start7 Dec 2026 (estimated)
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
155 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06975176
Sponsor's protocol ID
HIV Stigma
Status last verified
Nov 2026
First submitted
18 Mar 2025
Last updated
3 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Stigma reduction intervention in people with Hiv, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sophie Watson (612-301-3051, watso684@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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