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 2026-10-30.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 80 is close to the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2028, 21 months later.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 21 months is close to that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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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