NCT07792148 - Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

80

Conditions

PrEP Use

Interventions

PrEPared Minds/ Mentes PrEParadas - Cognitive Behavioral TherapyBEHAVIORAL

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 InterventionOTHER

Participants do not receive PrEPared Minds/ Mentes PrEParadas intervention.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Dirk Davis, PhD, MPH

CONTACT

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