Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV

NCT07792148 | Not Yet Recruiting DMC

• 2 other identifiers: IRB00121001K01MH134676
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to adapt, implement, and evaluate a 10-session mental health intervention with men who have sex with men at the Regional AIDS Interfaith Network to find out if it will reduce anxiety and depression and increase awareness and use of pre-exposure prophylaxis (PrEP), a medication to prevent HIV.

Conditions

PrEP Use

Keywords

depression; anxiety; men who have sex with men

Outcome Measures

Primary Outcomes (9)

• Depression Questionnaire- PHQ-9

  The Patient Health Questionnaire-9 (PHQ-9) is a 9-question self-report tool used to screen, diagnose, monitor, and measure the severity of depression. Total score range is 0-27 with higher score indicating higher severity of depression.

  Baseline

• Depression - PHQ-9 instrument

  The Patient Health Questionnaire-9 (PHQ-9) is a 9-question self-report tool used to screen, diagnose, monitor, and measure the severity of depression. Total score range is 0-27 with higher score indicating higher severity of depression.

  Month 3 Post Randomization

• Depression - PHQ-9 instrument

  The Patient Health Questionnaire-9 (PHQ-9) is a 9-question self-report tool used to screen, diagnose, monitor, and measure the severity of depression. Total score range is 0-27 with higher score indicating higher severity of depression.

  Month 6 Post Randomization

• Anxiety Questionnaire - GAD-7

  The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to screen for generalized anxiety disorder and measure symptom severity. Total score range is 0-21 with higher score indicating higher severity of anxiety.

  Baseline

• Anxiety - GAD-7 instrument

  The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to screen for generalized anxiety disorder and measure symptom severity. Total score range is 0-21 with higher score indicating higher severity of anxiety.

  Month 3 Post Randomization

• Anxiety - GAD-7 instrument

  The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to screen for generalized anxiety disorder and measure symptom severity. Total score range is 0-21 with higher score indicating higher severity of anxiety.

  Month 6 Post Randomization

• PrEP Uptake

  Number of participants that self-report PrEp use

  Baseline

• PrEP Uptake

  Number of participants that self-report PrEp use

  Month 3 Post Randomization

• PrEP Uptake

  Number of participants that self-report PrEp use

  Month 6 Post Randomization

Study Arms (2)

Intervention

EXPERIMENTAL

participants randomized to the intervention

Behavioral: PrEPared Minds/ Mentes PrEParadas - Cognitive Behavioral Therapy

Control Group

ACTIVE COMPARATOR

participants not receiving the intervention

Other: No Intervention

Interventions

PrEPared Minds/ Mentes PrEParadas - Cognitive Behavioral Therapy BEHAVIORAL

PrEPared Minds/Mentes PrEParadas is an adapted, bilingual (English/Spanish) affirmative cognitive behavioral intervention designed to improve mental health and promote HIV prevention. Intervention includes 10 one-hour sessions of skills-building cognitive behavioral therapy.

Intervention

No Intervention OTHER

Participants do not receive PrEPared Minds/ Mentes PrEParadas intervention.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: men who have sex with men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as a man who has sex with men
• Able to speak, read, and write in Spanish or English
• Never received and HIV diagnosis
• Reports HIV acquisition risk in; by having confirmed any of the following in the past 6 months: (a) have had sex with a partner living with HIV; (b) have had sex with a partner whose HIV status was unknown to you; (c) have had anal sex without a condom; or (d) have been diagnosed with gonorrhea, chlamydia or syphillis
• Not currently using PrEP as prescribed
• Experiencing mild to moderate anxiety symptoms within the past 2 weeks, defined as a GAD-7 score of 5 - 14, on the GAD-7 anxiety screener or mild to moderate depressive symptoms within the past 2 weeks, defined as a PHQ-9 score of 5 - 14 on the depression screener

You may not qualify if:

• Severe anxiety (≥15 on the GAD-7 screener), depression (≥ 15 on the PHQ-9 screener) or active suicidality
• Reports minimal depression and anxiety symptoms, defined as both a GAD-7 score ≤ 4 and a PHQ-9 score ≤ 4.
• Report of current or history of serious mental illness including but not limited to schizophrenia, schizoaffective disorder, bipolar disorder or another psychotic disorder
• Currently receiving mental health services (for more than 1 month)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders; Homosexuality

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sexuality; Sexual Behavior

Study Officials

• Dirk Davis, PhD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Davis, PhD, MPH

CONTACT

704-609-9752; dirk.davis@wfusm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• 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 (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following publication
• Access Criteria: Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.