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

NCT ID: NCT07263048

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-31
• Study Completion Date: 2029-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PrEP & Soccer Intervention

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

Group Type: EXPERIMENTAL

PrEP & Soccer PrEP Navigation

Intervention Type: 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.

Standard of care (CVS standard health information)

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

Group Type: ACTIVE_COMPARATOR

CVS Health brochure

Intervention Type: BEHAVIORAL

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

Interventions

PrEP & Soccer PrEP Navigation

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.

Intervention Type: BEHAVIORAL

CVS Health brochure

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Mariano Juan Kanamori Nishimura

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariano R Kanamori, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Central Contacts

Maria R Velazquez, MPA

Role: CONTACT

mrvelazquez@med.miami.edu

305-243-1946

Facility Contacts

Maria R Velazquez, MPA

Role: primary

mrvelazquez@med.miami.edu

305-243-1946

Other Identifiers

1R01AI191576-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20250645

Identifier Type: -

Identifier Source: org_study_id