University of Miami
Miami, Florida, 33136, United States
Location contact
Maria R Velazquez, MPA
CONTACT
Mariano Kanamori, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07263048
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.
Trial opening soon.
Get Notified18 year–54 year
Male
Interventional
Not applicable
Miami, Florida, 33136, United States
Maria R Velazquez, MPA
CONTACT
Mariano Kanamori, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Standard health information delivered via brochure, no active navigation components. Content includes a brochure describing services offered by CVS Health and the MinuteClinic.
Time frame: Baseline, 3 months, and 6 months
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
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.
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.
Contact information is provided by the study sponsor or research team.
University of Miami
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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