About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PrEP & Soccer PrEP Navigation
- CVS Health brochure
Treatment groups
Sponsors and collaborators
University of Miami
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator