Five Point Initiative: A Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06062342
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • FPI — BEHAVIORAL
    The FPI intervention will be conducted twice per month (across 21 months) in a zip code, and each event will last approximately 4-5 hours. At the event, participants will receive HIV testing, PrEP linkage (e.g., prescription) and knowledge, and condom and use/access.

Study Details

The purpose of this study is to assess the effectiveness of the FPI bundled implementation strategy in increasing HIV testing, Pre-exposure prophylaxis (PrEP) linkage (e.g., prescription) and knowledge, and condom use/access.

Key Dates

Start date
Feb 2, 2024
Status verified
Jul 2025
Primary completion
Dec 1, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
20,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: FPI Group
    Participants in this group will receive the FPI intervention at any FPI coordinated outreach event (4-5 hours) during a 21 month period
  • No Intervention: Pre-intervention Assessment Group
    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.

Primary Outcome Measure

Change in number of residents with recent HIV testing [ Time Frame: Up to 23 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Sannisha Dale, PhD
(305) 243-6714
Sannisha Dale, PhD (PRINCIPAL_INVESTIGATOR)

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