Health TrialsbyHealthPanel

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

ConditionsHIV PreventionLatino Men Who Have Sex With MenPharmacy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-54
SponsorUniversity of Miami

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PrEP & Soccer PrEP Navigation

    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.

  • CVS Health brochure

    Behavioral

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

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: PrEP & Soccer InterventionExperimental treatment 1 intervention
Group B: Standard of care (CVS standard health information)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Self-report attendance at first PrEP appointment

Attendance at the first scheduled PrEP (pre-exposure prophylaxis) appointment will be assessed using self-report responses at baseline, 3 months, and 6 months. Participants will respond to the question: "Did you attend your first scheduled PrEP appointment?" with binary options (Yes/No). This will be measured by the percentage of participants responding "Yes" at each time point and will evaluate engagement with PrEP services over time.

Time frame
Baseline, 3 months, and 6 months

Secondary outcomes

1

PrEP Cascade Questionnaire, measured by participant survey responses

The PrEP Cascade Questionnaire is a structured survey designed to assess participant engagement across stages of the PrEP prevention cascade (awareness, access, initiation, adherence, and retention). Each item will be scored as binary (Yes/No) or categorical (e.g., aware/not aware, initiated/not initiated, adherent/non-adherent). This will be measured by the percentage of participants meeting each cascade stage at each time point and will evaluate the progression through the PrEP cascade over time.

Time frame
Baseline, 3 months, and 6 months
2

Percentage of correct PrEP questions, measured by participant survey responses

The PrEP Questionnaires is a structured survey designed to assess participant PrEP knowledge. Each item will be scored as binary (Yes/No) or categorical. This will be measured by the percentage of correct responses at each time point and will evaluate PrEP knowledge over time.

Time frame
Baseline, 3 months, and 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: