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

NCT ID
NCT07792148
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Wake Forest University Health Sciences
Conditions
PrEP Use

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 80 participants (Estimated).

What is being studied

  • Other: No Intervention
  • Behavioral: PrEPared Minds/ Mentes PrEParadas - Cognitive Behavioral Therapy

Who may be eligible

Ages
18 Years to no maximum
Sex
Male
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility criteria.

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)

Study locations

No study locations are listed in the registry data.

Study details

Start date
October 1, 2026
Primary completion date
August 1, 2028
Completion date
August 1, 2028
First posted
August 28, 2026
Collaborators
National Institute of Mental Health (NIMH)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07792148
Registry last updated
September 24, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07792148 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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