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

University of Miami

Status: Begins enrollment in 4 months

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

Treatments: Behavioral: PrEP & Soccer PrEP Navigation; Behavioral: CVS Health brochure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07263048

20250645

1R01AI191576-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: Male

Ages: 18 to 54 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

PrEP & Soccer Intervention

Experimental group

Description:

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

Treatment:

Behavioral: PrEP & Soccer PrEP Navigation

Standard of care (CVS standard health information)

Active Comparator group

Description:

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

Treatment:

Behavioral: CVS Health brochure