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Soccer-Themed program aims to boost HIV prevention in men

NCT ID NCT07263048

Prevention Sponsor: University of Miami 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study tests a program called PrEP & Soccer, run through CVS pharmacies, to help men learn about and start PrEP—a daily pill that prevents HIV. About 800 men aged 18-54 who are at risk for HIV will take part. Some pharmacies will offer personalized PrEP navigation and a soccer-themed pamphlet, while others provide only standard health information. The goal is to see if the program increases attendance at first PrEP appointments and improves HIV prevention awareness.

What this could mean

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

Active substance
PrEP navigation support and educational brochure
What this could lead to
If successful, this program could make it easier for men at risk of HIV to learn about and start PrEP, potentially reducing new infections.
What could go wrong
This is an early-stage implementation study, not a drug trial. The program may not increase PrEP use as hoped, and results may not apply to other settings or populations.

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 800 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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 to 54 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Provide their informed consent to participate. * Demonstrate willingness to comply with all study procedures and be available for the study duration. * Ages 18 to 54 years of age. * A man. * Self-report any of the following behaviors and/or health conditions 1. Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia) 2. Sex with a partner who is living with HIV 3. Sex without a condom with two or more partners whose HIV status were unknown 4. Injection drug use and sharing injection equipment * Have been without a PrEP prescription for at least 24 weeks. Exclusion Criteria: * Diminished capacity to consent due to: 1. Inability to provide informed consent (e.g., cognitive impairment), or 2. Presence of severe psychiatric symptoms (e.g., mania, psychosis) that impair the ability to provide informed consent, as assessed by interviewers trained in CITI Human Subjects Research and NIH Good Clinical Practice. * Younger than 18 or older than 54 years of age. * A woman. * Does not self-report any of the following behaviors and/or health conditions 1. Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia) 2. Sex with a partner who is living with HIV 3. Sex without a condom with two or more partners whose HIV status were unknown 4. Injection drug use and sharing injection equipment * Has had an active PrEP prescription within the past 24 weeks. * Living with HIV (e.g. has received an HIV diagnosis). * Planning to move outside of Miami-Dade or Broward counties in the next 7 months.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

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

HIV prevention Latino men who have sex with men Pharmacy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

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