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New behavioral program aims to curb HIV and drug use in High-Risk men

NCT ID NCT07281378

Prevention Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This study tests a six-session behavioral program for stimulant-using men at high risk for HIV. The program focuses on positive thinking, mindfulness, and building supportive networks to help participants start taking PrEP (a daily pill that prevents HIV) and reduce stimulant use and risky sex. The trial will enroll 84 men across the U.S. to see if the program is feasible and acceptable.

What this could mean

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

Active substance
Tailored Positive Affect Intervention (behavioral counseling sessions)
What this could lead to
If it works, this could point toward an effective way to help stimulant-using men start PrEP and lower their HIV risk.
What could go wrong
This is a small pilot study (84 people) testing feasibility, not proof of effectiveness. Results may not apply broadly, and behavioral interventions can have mixed success.

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 84 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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: 1. be 18 years of age or older; 2. be sexually active cisgender men at high risk for HIV (foreign and US-born, residing in the US)-reporting any condomless anal sex (CAS) in the past three months with a man; 3. report use of stimulant (i.e., methamphetamine, powder cocaine, or crack-cocaine) at least one day in the past three or six month; 4. have HIV-negative serostatus; 5. be bilingual (Spanish and English), or Spanish or English monolingual; 6. meet CDC criteria for PrEP eligibility. Exclusion Criteria: 1. display diminished capacity to consent (e.g., cognitive impairment); or 2. severe psychiatric symptoms (e.g., psychosis) that require more intensive treatment; 3. if they are HIV positive or living with HIV; 4. if they are already taking PrEP; and 5. if the participant can't consent to participate in English or Spanish.

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Conditions

The condition(s) this trial relates to.

substance-related disorder HIV infectious disease prevention target

As listed by the trial registrant

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

Drug use disorders HIV risk behavior Prep adherence Prep uptake

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.