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Stigma, SocialNCT07793357

TENNacity Trial: A Pilot Test of Intersectional CBT Among Young Southern Black and Latino/x GBQ+ Men

A study testing Adapted ESTEEM intervention in people with Stigma, Social, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This open pilot involves testing the acceptability and feasibility of an intersectional, culturally responsive health intervention by piloting it among young Black and Latino/x gay, bisexual, and queer (GBQ+) men residing in Middle Tennessee. Read more about this study

Who is it for?
Ages 18 to 35 years, men only
Conditions the study is for
Stigma, Social
What is being tested?
Adapted ESTEEM intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
16 Apr 2025to 19 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

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 35 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • identify as male
  • anticipate 6-months of residential stability in Nashville (or surrounding service area)
  • identify as gay, bisexual, or report past-12-month sex with a man
  • identify as Black and/or Latino
  • speak fluent English
  • provide consent

Who cannot join

  • exhibit symptoms of psychosis, mania, or gross cognitive impairment (assessed by a clinician during pre-assessment)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nashville CARES Community Clinic

    Nashville, Tennessee, 37201

Other trials in United States

About this study

Official title: Southern TENNacity: An Open Pilot of LGBTQ-Affirmative CBT Adapted for Young Black and Latino/x Gay, Bisexual, and Queer Men in the US South

This open pilot involves testing the acceptability and feasibility of an intersectional, culturally responsive health intervention by piloting it among young Black and Latino/x gay, bisexual, and queer (GBQ+) men residing in Middle Tennessee. Qualitative exit interviews will be conducted to provide information regarding intervention feasibility, acceptability, and refinement; changes in primary and secondary study outcomes will help assess efficacy potential. Effective Skills to Empower Effective Men (ESTEEM), has been shown to decrease negative mental health symptomology and HIV risk behavior among a racially diverse sample of young GBQ+ men. This study would inform the cultural adaptation of ESTEEM to fit the unique and intersectional experiences of Black and Latino/x GBQ+ men living in the South, and in particular within Middle TN. The adaptation and group pilot stands to significantly improve stigma coping and the mental/sexual health of Black and Latino/x GBQ+ men in Middle TN-and in turn impact the HIV burden in the Southern US.

Read the detailed description

These research activities seek to further the reach and cultural-appropriateness of a clinically effective evidence-based intervention (ESTEEM) by further adapting ESTEEM-conneCT (a group-based treatment designed for gay and bisexual men of color in Fair Haven, CT) for young Black and Latino/x GBM residing in Middle Tennessee. The intervention study will take place in Nashville, TN with a partnership between the Nashville CARES and the Yale School of Public Health (YSPH). This pilot will guide further refinement, identify facilitators and barriers to scaling up, and yield effect size estimates for powering future studies.

Conditions
Stigma, Social
Being tested
Adapted ESTEEM intervention
Medical subject headings
Social Stigma

What participants receive

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

  • Adapted ESTEEM interventionBehavioural

    culturally-responsive behavioral health intervention

Study groups in NCT07793357
Study groupRoleWhat they receive
Adapted ESTEEM interventionExperimentalParticipants will receive the adapted ESTEEM intervention over 11 sessions
Receives: Behavioral: Adapted ESTEEM intervention

What is being measured

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

  1. Center for Epidemiological Studies-Depression Scale (CES-D) score

    The CES-D is a 20-item measure that assesses frequency of past-week depression symptoms (e.g., "I was bothered by things that usually don't bother me") on a 4-point scale from 0 (rarely or none of the time [less than 1 day]) to 3 (most or all of the time [5-7 days]). The item scores are summed, with higher scores indicating greater risk for clinical depression. Total score range 0-80.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  2. Overall Depression Severity and Impairment Scale (ODSIS) score

    ODSIS is a 5-item self-report scale that asks participants to rate the severity and impairment associated with past-week symptoms of depression (e.g., "In the past week, when you have felt depressed, how intense or severe was your depression?") from 0 (little or none: Depression was absent or barely noticeable.) to 4 (extreme: Depression was overwhelming.). The item scores are summed, with higher scores indicating greater severity and impairment. Total score range 0-20.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  3. Overall Anxiety Severity and Impairment Scale (OASIS) score

    OASIS is a 5-item self-report scale that asks participants to rate the severity and impairment associated with past-week anxiety symptoms (e.g., "In the past week, when you have felt anxious, how intense or severe was your anxiety?") from 0 (little or none: Anxiety was absent or barely noticeable.) to 4 (extreme: Anxiety was overwhelming. It was impossible to relax at all. Physical symptoms were unbearable). The item scores are summed, with higher scores indicating greater severity and impairment. Total score range 0-20.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  4. Brief Symptom Inventory (BSI) score

    The 18-item BSI provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). The item scores are summed with higher scores indicating greater severity and impairment. Total score range 0-72.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  5. Suicidal Ideation Attributes Scale (SIDAS) score

    SIDAS is a 5-item self-report scale that assesses past-month frequency and controllability of suicidal thoughts, how close one has come to making an attempt, and distress and impairment associated with thoughts of suicide (e.g., "In the past month, how often have you had thoughts about suicide?"). Responses range from 0 (never or not at all) to 10 (always or extremely). The item scores are summed, with higher scores indicating greater severity of suicidal ideation. Total score range 0-50.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  6. Short Inventory of Problems - Alcohol and Drugs (SIP-AD) score

    SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use?). The item scores are summed, with higher scores indicating greater problems related to drugs and alcohol. Total score range 0-15.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  7. Mean Recent HIV-risk Acts

    Mean Number of Recent HIV-risk Acts self reported using the timeline follow-back method

    Measured: Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)

  8. Psychological Health Change

    The number of the mental health variables that change in the expected direction. The eight psychological health variables include: depressive symptoms; anxiety; social anxiety; suicidal ideation; psychological distress; substance use problems; rumination; and assertiveness.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  9. Sexual Health Change

    The number of sexual health variables that change in the expected direction. The four sexual health variables include: Recent HIV transmission risk acts; condom use self-efficacy; sexual compulsivity; and recent PrEP use.

    Measured: Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)

  10. Social Interaction Anxiety Scale score

    A 20-item self-report scale that assesses fear, distress, and anxiety a person feels during general social interactions. Responses range from 0 (Not at all characteristic of me) to 4 (Extremely characteristic of me). The item scores are summed, with higher scores indicating greater level of social anxiety. Total score range 0-80.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

Secondary outcomes (22)
  1. Mean score Ruminative Responses Scale - Brooding Subscale

    The Brooding Subscale is a 5-item measure that assesses maladaptive cognitive patterns when feeling down, sad, or depressed (e.g., "Think 'why do I always react this way?'") on a 4-point scale from 1 (Almost Never) to 4 (Almost Always). The item scores are averaged, with higher scores indicating greater ruminative brooding. Total score range 0-4.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  2. Rathus Assertiveness Schedule score

    The Rathus Assertiveness Schedule is a 30-item measure that assesses assertiveness and passivity (e.g., "I often have a hard time saying 'No.'") on a 6-point scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). The item scores are summed, with positive scores indicating higher assertiveness and negative scores indicating lower assertiveness or passivity. Total score range 90 to -90.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  3. Alcohol Use Disorders Identification Test (AUDIT) score

    The AUDIT assesses past-3-month alcohol and related problems across 10 items (e.g., "How often did you have a drink containing alcohol?") with varying numeric response options (0-4). The item scores are summed, with higher scores indicating greater alcohol-related risk. Total score range 0-40.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  4. Mean score Safer Sex Self-Efficacy Questionnaire

    Condom use self-efficacy will be measured by calculating mean scores on the Safer Sex Self-Efficacy Questionnaire. The Safer Sex Self-Efficacy Questionnaire is a 13-item measure that assesses confidence in avoiding having anal sex without a condom in different situations (e.g., "When you are with someone who is really hot?") on a 5-point scale from 1 (Not at all confident) to 5 (Extremely confident). The item scores are averaged, with higher scores indicating greater condom use self-efficacy. Total score range 1-13.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  5. Sexual Compulsivity Scale score

    The Sexual Compulsivity Scale is a 10-item measure that assesses difficulties regulating sexual desire (e.g., "I think about sex more than I would like to") on a 4-point scale from 1 (Not at all lke me) to 4 (Very much like m). The item scores are summed, with higher scores indicating greater Sexual Compulsivity. Total score range 10-40.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  6. Percent participants with recent PrEP use

    Recent PrEP use will be measured by calculating proportions of participants who reported any PrEP use over the past 3 months. Three types of PrEP were described before participants were asked, "Which methods of PrEP (Pre-Exposure Prophylaxis) administration have you used to reduce the risk of getting HIV over the past 3 months? Select all that apply." Answer options included Daily PrEP (i.e., 4-7 days a week), On-demand PrEP (i.e., the "2-1-1" schedule), Injectable PrEP (i.e., every two months), and I have not taken PrEP in any form over the past three months.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  7. Stigma Coping Strategies

    Number of protective strategies that increased and risk-enhancing strategies that decreased.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  8. Stigma Coping- Adaptiveness Scale score

    Coping response will be scored on a 5-point adaptiveness scale (created for this study) ranging from 1 (Definitely adaptive [or almost certainly so]) to 5 (Definitely maladaptive [or almost certainly so]) with higher scores indicating worse coping. Total score range 1-5.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  9. Internalized Homophobia Scale score

    The Internalized Homophobia Scale is a 9-item measure that assesses internalized homophobia on a 4-point scale from 1 (Never) to 4 (Often). The item scores are summed, with higher scores indicating greater internalized homophobia. Total score range 9-36.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  10. Gay-Related Rejection Sensitivity Scale score

    The Gay-Related Rejection Sensitivity Scale is a 14-item measure that the likelihood of expecting rejection by heterosexuals in more or less ambiguous situations with answers on a scale ranging from 1 to 6 with higher scores indicating greater rejection. Total score range 1-6.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  11. Mean Outness Inventory (OI) score

    The OI is an 11-item scale designed to assess the degree to which lesbian, gay, bisexual, and queer individuals are open about their sexual orientation. Responses on OI items indicate the degree to which the respondent's sexual orientation is known by and openly discussed with various types of individuals on a 7-point scale from 1 (person definitely does NOT know about your sexual orientation status) to 7 (person definitely knows about your sexual orientation status, and it is OPENLY talked about); if the person of group is not relevant to them, participants select 0 (not applicable to your situation; there is no such person or group of people in your life). The item scores are averaged, with higher scores indicating greater sexual orientation disclosure. Total score range 0-4.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  12. Mean Sexual Orientation Concealment Scale (SOCS) score

    This version of the Self-Concealment Scale is a 6-item measure that assesses sexual ), a brief self-report measure assessing effort to conceal one's sexual identity in one's current life (e.g., "In the last 2 weeks, I have altered my appearance, mannerisms, or activities in an attempt to 'pass' as straight.") on a 5-point scale from 1 (Not at all) to 5 (All the time). The item scores are averaged, with higher scores indicating greater concealment. Total score range 1-5.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  13. Internalized Racism score

    Internalized racism will be measured as mean of participant scores on a 5-item measure that assesses negative thoughts and beliefs about one's own racial minority status. Participants were presented with a question regarding their racial/ethnic identity (e.g., "How do you feel today about being a person of your racial/ethnic background?"), which they answer by completing five semantic differential scales, each ranging from 1 (a negative characteristic) to 5 (a corresponding positive characteristic): uncomfortable to comfortable, dissatisfied to satisfied, ashamed to proud, strong to weak, and self-accepting to self-rejecting. The item scores are summed, with higher scores indicating greater internalized racism. Total score range 5-25.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  14. Mean Racism-Related Vigilance scale score

    The scale is a 7-item measure includes four items that assess (a) racial/ethnic vigilance (e.g., "try to prepare for possible insults from other people before leaving home") on a 4-point scale from 0 (Rarely) to 3 (Almost every day), total score range 0-3.and (b) race-related sleep disturbance over the past four weeks (e.g., waking very early with trouble getting back to sleep) on a 5-point scale from 1 (At least once a week) to 5 (Never), total score range 1-5. The item scores are averaged, with higher scores indicating greater race-related vigilance.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  15. Anticipatory Race-Related Stress Subscale of the Prolonged Activation and Anticipatory Race-Related Stress Scale score

    The Anticipatory Race-Related Stress Subscale is a 4-item measure that assesses race-related anticipatory stress on a 7-point scale from 1 (Not at all stressful) to 7 (Extremely Stressful). The item scores are averaged, with higher scores indicating greater race-related anticipatory stress. Total score range 1-7.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  16. Heterosexism & Cissexism in Communities of Color Subscale of the LGBTQ+ PCMS-R score

    This is a 6-item subscale measure that assesses perceived heterosexism within one's racial/ethnic community on a 7-point scale from 0 (Not applicable) to 6 (Always). Then, participants are presented with directions reading, "Imagining if you were to experience ongoing anti-LGBTQ stigma within your racial/ethnic community, such as:" and all six subscale items were presented. They are then asked, "If you were to encounter situations like these..." before encountering three follow-up questions to assess distress (e.g., "to what extent would the situation stress or bother you?"). The initial subscale score is multiplied by the stress score to compute stress related to heterosexism in one's racial/ethnic community, with higher scores indicating greater intracommunity heterosexism. Total score range 0-30.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  17. Racism within LGBTQ+ Communities Subscale of the LGBTQ+ PCMS-R score

    This is a 6-item subscale measure that assesses perceived racism in the White LGBTQ+ community (e.g., "I have felt misunderstood by White LGBTQ+ people because I am a POC.") on a 5-point scale from 1 (To a little extent) to 5 (To a great extent). Then, participants are presented with directions reading, "Imagining if you were to experience ongoing racism within the LGBTQ+ community, such as:" and all six subscale items were presented. They are then asked, "If you were to encounter situations like these..." before encountering three follow-up questions to assess distress (e.g., "to what extent would the situation stress or bother you?"). The initial subscale score is multiplied by the stress score to compute stress related to heterosexism in one's racial/ethnic community, with higher scores indicating greater intracommunity heterosexism. Total score range 0-30.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  18. Conflicts in Allegiances Scale score

    The Conflicts in Allegiances Scale is a 6-item subscale measure that assesses conflicts between the racial/ethnic and sexual orientation identities they endorsed previously within the survey (e.g., "I separate my [insert sexual orientation] and [insert racial/ethnic group] identities.") on a 7-point scale from 1 (Disagree strongly) to 7 (Agree strongly). The item scores are averaged, with higher scores indicating greater identity conflict. Total score range 1-7.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  19. Queer People of Color Identity Affirmation Scale score

    This is a 12-item measure that assesses identity affirmation among LGBTQ+ people of color on a 7-point scale from 1 (Very strongly disagree) to 7 (Very strongly agree). The item scores are averaged, with higher scores indicating greater Southern LGBTQ-POC identity strength. Total score range 1-7.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  20. Queer and Trans Black, Indigenous, and People of Color (QT-BIPOC) Resilience Measure score

    This is a 20-item subscale measure that assesses the ways oppression has shaped their individuals and community QT-BIPOC resilience on a 7-point scale from 1 (Strongly Disagree) to 7 (Strongly Agree). The item scores are averaged, with higher scores indicating greater intersectional stigma resilience. Total score range 1-7.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  21. Stigma-Related Stress Change

    Number of the mental health variables that change in the expected direction out of the 13 psychological health variables.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)

  22. Perseverative Cognition Subscale Subscale of the Prolonged Activation and Anticipatory Race-Related Stress Scale score

    The Perseverative Cognition Subscale Subscale is a 5-item measure that assesses race-related rumination on a 7-point scale from 1 (Not at all stressful) to 7 (Extremely stressful). The item scores are averaged, with higher scores indicating greater race-related anticipatory stress. Total score range 1-7.

    Measured: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)]

Timeline

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

  1. First posted28 Aug 2026
  2. Study start16 Apr 2025
  3. Primary completion19 Nov 2025
  4. Study completion19 Nov 2025

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07793357
Sponsor's protocol ID
2000034419
Other IDs
1K01MH122316-01A1
Status last verified
Aug 2026
First submitted
25 Aug 2026
Last updated
28 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified qualitative and quantitative IPD will be preserved and shared with qualified researchers upon request.

Questions about this trial

What is this clinical trial studying?

A study testing Adapted ESTEEM intervention in people with Stigma, Social, run by Yale University 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 6 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: finished, as of the sponsor's last update on 28 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Center for Epidemiological Studies-Depression Scale (CES-D) score (time frame: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)). The study lists 10 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 28 Aug 2026.

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