Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07263048

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–54 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location contact

Maria R Velazquez, MPA

CONTACT

[email protected]

305-243-1946

Mariano Kanamori, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Exclusion criteria

  • 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.
  • 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
  • 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
  • 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.

Treatment and study plan

PrEP & Soccer PrEP Navigation

Behavioral

Pharmacies assigned to this group will receive personalized PrEP navigation support provided by a PrEP Navigator following baseline assessment. Sessions may be brief (~15 minutes) or longer depending on participant needs. The navigator supplies a pamphlet describing PrEP (how it works, payment options), and CVS-provided HIV services; discusses whether PrEP or another HIV prevention strategy is best for the participant; and, if PrEP is selected, provides a referral to a PrEP provider.

CVS Health brochure

Behavioral

Standard health information delivered via brochure, no active navigation components. Content includes a brochure describing services offered by CVS Health and the MinuteClinic.

Primary outcomes

  1. Self-report attendance at first PrEP appointment

    Time frame: Baseline, 3 months, and 6 months

    Attendance at the first scheduled PrEP (pre-exposure prophylaxis) appointment will be assessed using self-report responses at baseline, 3 months, and 6 months. Participants will respond to the question: "Did you attend your first scheduled PrEP appointment?" with binary options (Yes/No). This will be measured by the percentage of participants responding "Yes" at each time point and will evaluate engagement with PrEP services over time.

Secondary outcomes

  1. PrEP Cascade Questionnaire, measured by participant survey responses

    Time frame: Baseline, 3 months, and 6 months

    The PrEP Cascade Questionnaire is a structured survey designed to assess participant engagement across stages of the PrEP prevention cascade (awareness, access, initiation, adherence, and retention). Each item will be scored as binary (Yes/No) or categorical (e.g., aware/not aware, initiated/not initiated, adherent/non-adherent). This will be measured by the percentage of participants meeting each cascade stage at each time point and will evaluate the progression through the PrEP cascade over time.

  2. Percentage of correct PrEP questions, measured by participant survey responses

    Time frame: Baseline, 3 months, and 6 months.

    The PrEP Questionnaires is a structured survey designed to assess participant PrEP knowledge. Each item will be scored as binary (Yes/No) or categorical. This will be measured by the percentage of correct responses at each time point and will evaluate PrEP knowledge over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria R Velazquez, MPA

CONTACT

[email protected]

305-243-1946

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.