An interventional study of PrEPared Minds/ Mentes PrEParadas - Cognitive Behavioral Therapy and No Intervention in PrEP Use, sponsored by Wake Forest University Health Sciences. Not yet recruiting. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
participants randomized to the intervention
Behavioral: PrEPared Minds/ Mentes PrEParadas - Cognitive Behavioral Therapy
participants not receiving the intervention
Other: No Intervention
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.
Participants do not receive PrEPared Minds/ Mentes PrEParadas intervention.
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.
Time frame: Month 6 Post Randomization
PrEP Uptake
Number of participants that self-report PrEp use
Time frame: Baseline
PrEP Uptake
Number of participants that self-report PrEp use
Time frame: Month 3 Post Randomization
PrEP Uptake
Number of participants that self-report PrEp use
Time frame: Month 6 Post Randomization
No study locations are listed for this record.
Plan to share: Yes — Individual participant data that underlie results reported, after deidentification.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences