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

NCT07263048 | Not Yet Recruiting DMC

• 2 other identifiers: 202506451R01AI191576-01
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Prevention; Latino Men Who Have Sex With Men; Pharmacy

Outcome Measures

Primary Outcomes (1)

• Self-report attendance at first PrEP appointment

  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.

  Baseline, 3 months, and 6 months

Secondary Outcomes (2)

• PrEP Cascade Questionnaire, measured by participant survey responses

  Baseline, 3 months, and 6 months

• Percentage of correct PrEP questions, measured by participant survey responses

  Baseline, 3 months, and 6 months.

Study Arms (2)

PrEP & Soccer Intervention

EXPERIMENTAL

Pharmacies assigned to "PrEP \& Soccer" group will receive personalized PrEP navigation support from the PrEP Navigator.

Behavioral: PrEP & Soccer PrEP Navigation

Standard of care (CVS standard health information)

ACTIVE COMPARATOR

Pharmacies assigned to the control group will receive a brochure describing services offered by CVS Health and the MinuteClinic.

Behavioral: CVS Health brochure

Interventions

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.

PrEP & Soccer Intervention

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.

Standard of care (CVS standard health information)

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

• Mariano R Kanamori, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria R Velazquez, MPA

CONTACT

305-243-1946; mrvelazquez@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 8 pharmacies randomized 1:1

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 4, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)