HIV PreventionNCT07263048
PrEP & Soccer: A Program for Pharmacy Chains to Increase PrEP Awareness and Access Among Men
A study testing PrEP & Soccer PrEP Navigation and CVS Health brochure in people with HIV Prevention and Latino Men Who Have Sex With Men, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 years, men only
- Conditions the study is for
- HIV Prevention, Latino Men Who Have Sex With Men, Pharmacy
- What is being tested?
- PrEP & Soccer PrEP Navigation and CVS Health brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)
Show all 10Show fewer
- Sex with a partner who is living with HIV
- Sex without a condom with two or more partners whose HIV status were unknown
- Injection drug use and sharing injection equipment
- Have been without a PrEP prescription for at least 24 weeks.
Who cannot join
- Diminished capacity to consent due to:
- 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.
- Does not self-report any of the following behaviors and/or health conditions
Show all 13Show fewer
- Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)
- Sex with a partner who is living with HIV
- Sex without a condom with two or more partners whose HIV status were unknown
- Injection drug use and sharing injection equipment
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami
Miami, Florida, 33136
Maria R Velazquez, MPA, 305-243-1946, mrvelazquez@med.miami.edu
Mariano Kanamori, PhD
About this study
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
- Being tested
- PrEP & Soccer PrEP Navigation, CVS Health brochure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP & Soccer PrEP NavigationBehavioural
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 brochureBehavioural
Standard health information delivered via brochure, no active navigation components. Content includes a brochure describing services offered by CVS Health and the MinuteClinic.
| Study group | Role | What they receive |
|---|---|---|
| PrEP & Soccer Intervention | Experimental | Pharmacies assigned to "PrEP \& Soccer" group will receive personalized PrEP navigation support from the PrEP Navigator. Receives: Behavioral: PrEP & Soccer PrEP Navigation |
| 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. Receives: Behavioral: CVS Health brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start30 Oct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 8 pharmacies randomized 1:1
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariano Juan Kanamori Nishimura, University of Miami
- Investigators
- Mariano R Kanamori, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263048
- Sponsor's protocol ID
- 20250645
- Other IDs
- 1R01AI191576-01
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP & Soccer: A Program for Pharmacy Chains to Increase PrEP Awareness and Access Among Men
- ClinicalTrials.gov ID
- NCT07263048
- Acronym / sponsor ID
- 20250645
- Conditions
- HIV Prevention, Latino Men Who Have Sex With Men, Pharmacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 8 pharmacies randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| PrEP & Soccer Intervention | Experimental | Behavioral: PrEP & Soccer PrEP NavigationPharmacies assigned to "PrEP \& Soccer" group will receive personalized PrEP navigation support from the PrEP Navigator. |
| Standard of care (CVS standard health information) | Active comparator | Behavioral: CVS Health brochurePharmacies assigned to the control group will receive a brochure describing services offered by CVS Health and the MinuteClinic. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP & Soccer PrEP NavigationPharmacies 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. | Behavioural | PrEP & Soccer Intervention |
| CVS Health brochureStandard health information delivered via brochure, no active navigation components. Content includes a brochure describing services offered by CVS Health and the MinuteClinic. | Behavioural | Standard of care (CVS standard health information) |
Primary outcome
Self-report attendance at first PrEP appointment
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.
2 secondary outcomes
PrEP Cascade Questionnaire, measured by participant survey responses
Time frame: Baseline, 3 months, and 6 months
Percentage of correct PrEP questions, measured by participant survey responses
Time frame: Baseline, 3 months, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariano R Kanamori, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP & Soccer PrEP Navigation and CVS Health brochure in people with HIV Prevention and Latino Men Who Have Sex With Men, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria R Velazquez, MPA (305-243-1946, mrvelazquez@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report attendance at first PrEP appointment (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.