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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI191576-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP & Soccer Intervention | Experimental | Pharmacies assigned to "PrEP & Soccer" group will receive personalized PrEP navigation support from the PrEP Navigator. |
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| Standard of care (CVS standard health information) | Active Comparator | Pharmacies assigned to the control group will receive a brochure describing services offered by CVS Health and the MinuteClinic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
Have been without a PrEP prescription for at least 24 weeks.
Exclusion Criteria:
Diminished capacity to consent due to:
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria R Velazquez, MPA | Contact | 305-243-1946 | mrvelazquez@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mariano R Kanamori, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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8 pharmacies randomized 1:1
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| 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. |
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| Baseline, 3 months, and 6 months |
| 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. | Baseline, 3 months, and 6 months. |