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FPI Strategy for HIV Prevention (FPI Trial)
N/A
Recruiting
Led By Sannisha Dale, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 23 months
Awards & highlights
FPI Trial Summary
This trial will test if a strategy to increase HIV testing, PrEP use, condom access, and knowledge works.
Who is the study for?
This trial is for anyone at community events in Miami's predominantly Black neighborhoods with high HIV rates, like barbershops, beauty salons, corner stores, laundromats, and car service providers. It's not for those who can't fully understand the consent process or study procedures.Check my eligibility
What is being tested?
The study tests the 'Five Point Initiative' (FPI) strategy to see if it boosts HIV testing, knowledge about PrEP (a medication to prevent HIV), prescription linkage for PrEP, and condom use and access in these communities.See study design
What are the potential side effects?
Since this trial focuses on an implementation strategy rather than a medical treatment or drug intervention, there are no direct side effects associated with medications. However, participants may experience discomfort discussing personal health information.
FPI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 23 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PrEP knowledge as measured by Five Point Initiative - Community Survey
Change in number of residents with PrEP prescription
Change in number of residents with recent HIV testing
Secondary outcome measures
Change in condom access as measured by Five Point Initiative - Community Survey
Change in condom use as measured by Five Point Initiative - Community Survey
Number of residents with PrEP prescription by health organizations
+1 moreFPI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FPI GroupExperimental Treatment1 Intervention
Participants in this group will receive the FPI intervention at any FPI coordinated outreach event (4-5 hours) during a 21 month period
Group II: Pre-intervention Assessment GroupActive Control1 Intervention
We will conduct pre-assessment events (4-5 hours) during 1.5 months in each zip code (prior to the introduction of the FPI intervention) to capture information from residents /participants via survey.
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Who is running the clinical trial?
University of MiamiLead Sponsor
915 Previous Clinical Trials
391,478 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,812 Previous Clinical Trials
2,647,274 Total Patients Enrolled
Sannisha Dale, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
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