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

NCT07793357 | Completed

• 2 other identifiers: 20000344191K01MH122316-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stigma, Social

Outcome Measures

Primary Outcomes (10)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• Mean Recent HIV-risk Acts

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

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (22)

• Mean score Ruminative Responses Scale - Brooding Subscale

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

• Rathus Assertiveness Schedule score

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

• Alcohol Use Disorders Identification Test (AUDIT) score

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

• Mean score Safer Sex Self-Efficacy Questionnaire

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

• Sexual Compulsivity Scale score

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

Study Arms (1)

Adapted ESTEEM intervention

EXPERIMENTAL

Participants will receive the adapted ESTEEM intervention over 11 sessions

Behavioral: Adapted ESTEEM intervention

Interventions

Adapted ESTEEM intervention BEHAVIORAL

culturally-responsive behavioral health intervention

Adapted ESTEEM intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator
• Nashville CARES: collaborator

Study Sites (1)

Nashville CARES Community Clinic

Nashville, Tennessee, 37201, United States

Location

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Skyler Jackson, PhD

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: April 16, 2025
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)