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

NCT07263048 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-12-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Miami

    lead OTHER

Principal Investigators

  • Mariano R Kanamori, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07263048 on ClinicalTrials.gov