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

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.

• 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

• Depression Questionnaire- PHQ-9 [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.
• Depression - PHQ-9 instrument [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.
• Depression - PHQ-9 instrument [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.
• Anxiety Questionnaire - GAD-7 [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.
• Anxiety - GAD-7 instrument [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.
• Anxiety - GAD-7 instrument [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.
• PrEP Uptake [Baseline]: Number of participants that self-report PrEp use
• PrEP Uptake [Month 3 Post Randomization]: Number of participants that self-report PrEp use
• PrEP Uptake [Month 6 Post Randomization]: Number of participants that self-report PrEp use

Sex: Male, ages: 18 Years to any, accepts healthy volunteers

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)

• Dirk Davis, PhD, MPH, Principal investigator, Wake Forest University Health Sciences

NIH grants: K01MH134676