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 — BEHAVIORALThe 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 GroupParticipants 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 GroupWe 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
- Sannisha Dale, PhD(305) 243-6714
- SHINE Research Program
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | Sannisha Dale, PhD (PRINCIPAL_INVESTIGATOR) |
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