PrEP & Soccer: A Program for Pharmacy Chains to Increase PrEP Awareness and Access Among Men
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PrEP & Soccer PrEP Navigation, CVS Health brochure.
- Who it may be relevant to
- Registry conditions: HIV Prevention, Latino Men Who Have Sex With Men, Pharmacy. Basic parameters: 18 years — 54 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral 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. - 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.
Primary outcome measures
- Self-report attendance at first PrEP appointment [Time frame: Baseline, 3 months, and 6 months]
Secondary outcome measures (2)
- PrEP Cascade Questionnaire, measured by participant survey responses [Time frame: Baseline, 3 months, and 6 months]
- Percentage of correct PrEP questions, measured by participant survey responses [Time frame: Baseline, 3 months, and 6 months.]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT07263048 · 20250645 · 1R01AI191576-01