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NCT07263048Not yet recruiting

PrEP & Soccer: A Program for Pharmacy Chains to Increase PrEP Awareness and Access Among Men

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

This type 3 Hybrid Effectiveness-Implementation study will evaluate PrEP \& Soccer, a multicomponent and multilevel implementation strategy delivered by a pharmacy chain to increase PrEP knowledge and initial PrEP appointment attendance among men. Using mixed methods and implementation science approaches, this parallel cluster randomized controlled study will assess key implementation factors at CVS Health pharmacy locations assigned either to the PrEP \& Soccer intervention or to a general CVS Health service information-only control.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
800 (estimated)
First submitted
2 Dec 2025
Start date
30 Oct 2026
Primary completion date
Oct 2029
Lead sponsor
University of Miami
Diseases
HIV
NCT number
NCT07263048

What you commit to

  • Study type: Interventional
  • Planned participants: 800
  • From 30 Oct 2026 to the primary completion date, Oct 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Living with HIV (e.g. has received an HIV diagnosis).

Other illness

  • Diminished capacity to consent due to:
    • Inability to provide informed consent (e.g., cognitive impairment), or
    • 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.
  • Does not self-report any of the following behaviors and/or health conditions
    • Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)
    • Sex with a partner who is living with HIV
    • Sex without a condom with two or more partners whose HIV status were unknown
    • Injection drug use and sharing injection equipment

Age

  • Younger than 18 or older than 54 years of age.

Other

  • A woman.
  • Has had an active PrEP prescription within the past 24 weeks.
  • Planning to move outside of Miami-Dade or Broward counties in the next 7 months.

Who the study is looking for

  • 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
    • Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)
    • Sex with a partner who is living with HIV
    • Sex without a condom with two or more partners whose HIV status were unknown
    • Injection drug use and sharing injection equipment
  • Have been without a PrEP prescription for at least 24 weeks.

Age in the registry: 18 years to 54 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.