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Can talk therapy help men at HIV risk embrace PrEP?

NCT ID NCT07792148

Prevention Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

Researchers are testing a 10-session bilingual therapy program called PrEPared Minds/Mentes PrEParadas. The program uses cognitive behavioral therapy to reduce anxiety and depression in men who have sex with men. The goal is to see if improving mental health helps these men learn about and start using PrEP, a medication that prevents HIV. The study will compare men who receive the therapy with those who do not.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PrEPared Minds/Mentes PrEParadas, a 10-session bilingual cognitive behavioral therapy program
What this could lead to
If it works, this could point toward a way to improve mental health and increase HIV prevention through PrEP in men at risk.
What could go wrong
This is a small early-stage trial, so the therapy may not produce lasting changes or may not work for everyone. The results will need confirmation in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder Homosexuality HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prep use

How to take part

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