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

University of Miami

Status: Enrolling

Conditions: Hiv

Treatments: Behavioral: FPI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06062342

20230484

1R01MH134269-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 20,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any individual present during the community events at the "five points" (barbershop, hair/beauty salon store or salon, corner store/grocery/neighborhood restaurant, laundromats, car service provider [e.g. gas station, mechanic, car wash]) in predominantly Black communities in Miami where HIV prevalence is high.
• Pre- and Post-assessment: Individuals are only eligible to complete the survey one time during the Pre-Intervention and during the Post-Intervention phases.
• Intervention: Individuals are only eligible to participate in the Intervention phase of this study once every 6 months.

Exclusion criteria

• Individuals who are unable to completely and fully understand the informed (verbal) consent process and the study procedures.
• Individuals who have previously completed the survey during the Pre-Intervention and Post-Intervention phases.
• Individuals who have participated in the Intervention phase of this study within less than 6 months.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20,400 participants in 2 patient groups

FPI Group

Experimental group

Description:

Participants in this group will receive the FPI intervention at any FPI coordinated outreach event (4-5 hours) during a 21 month period

Treatment:

Behavioral: FPI

Pre-intervention Assessment Group

No Intervention group

Description:

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.