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NCT Number: NCT07792148

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

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.

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Key information

Conditions

PrEP Use Anxiety Disorders Behavior Behavioral Symptoms Depression Homosexuality Mental Disorders Sexual Behavior Sexuality

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

This study will assess the preliminary effectiveness of the PrEPared Minds/ Mentes PrEParadas intervention. After randomizing English and Spanish-speaking men who have sex with men (MSM) to the cognitive behavioral therapy intervention or control group, the study team will conduct quantitative assessments (at baseline, 3-months, 6-months post intervention) and pre/post intervention in-depth interviews with MSM to assess preliminary effectiveness on depression, anxiety, and PrEP uptake. We will also use structural equation modeling to explore the pathways through which the adapted intervention influences mental health and PrEP uptake.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

No intervention

Other

Participants do not receive PrEPared Minds/ Mentes PrEParadas intervention.

Primary outcomes

  1. Depression Questionnaire- PHQ-9

    Time frame: Baseline

    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.

  2. Depression - PHQ-9 instrument

    Time frame: Month 3 Post Randomization

    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.

  3. Depression - PHQ-9 instrument

    Time frame: Month 6 Post Randomization

    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.

  4. Anxiety Questionnaire - GAD-7

    Time frame: Baseline

    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.

  5. Anxiety - GAD-7 instrument

    Time frame: Month 3 Post Randomization

    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.

  6. Anxiety - GAD-7 instrument

    Time frame: Month 6 Post Randomization

    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.

  7. PrEP Uptake

    Time frame: Baseline

    Number of participants that self-report PrEp use

  8. PrEP Uptake

    Time frame: Month 3 Post Randomization

    Number of participants that self-report PrEp use

  9. PrEP Uptake

    Time frame: Month 6 Post Randomization

    Number of participants that self-report PrEp use

Study contacts

Contact information is provided by the study sponsor or research team.

Dirk Davis, PhD, MPH

CONTACT

[email protected]

704-609-9752

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: ESTEEM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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