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

Five Point Initiative: A Cluster Randomized Trial of a Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities

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.

Study Overview

• Status: Recruiting
• Conditions: Hiv
• Intervention / Treatment: Behavioral: FPI

• Study Type: Interventional
• Enrollment (Estimated): 20400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sannisha Dale, PhD; Phone Number: (305) 243-6714; Email: sdale@med.miami.edu
• Study Contact Backup: Name: SHINE Research Program; Email: shineresearch@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Sannisha Dale, PhD; Phone Number: (305) 243-6714; Email: sdale@med.miami.edu
      • Principal Investigator: Sannisha Dale, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: FPI; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of residents with recent HIV testing	Will be reported as proportion of residents with recent (within 12 months) HIV testing as measured by Five Point Initiative - Community Survey	Up to 23 months
Change in number of residents with PrEP prescription	Will be reported as proportion of residents with PrEP prescription as measured by Five Point Initiative - Community Survey	Up to 23 months
Change in PrEP knowledge as measured by Five Point Initiative - Community Survey	Will be reported as the proportion of residents that indicated 'Yes' on the survey.	Baseline and up to 23 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in condom use as measured by Five Point Initiative - Community Survey	Will be reported as the proportion of residents that indicated 'No' on the survey	Baseline and up to 23 months
Change in condom access as measured by Five Point Initiative - Community Survey	Will be reported as the proportion of residents that indicated 'Yes' on the survey	Baseline and up to 23 months
Proportion of residents with recent HIV testing by health organizations	Proportion of residents with recent (within 12 months) HIV testing by each of the participating health organizations.	Up to 23 months
Number of residents with PrEP prescription by health organizations	Number of residents with PrEP prescription by each of the participating health organizations.	Up to 23 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Sannisha Dale, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: PrEP; HIV prevention; HIV testing; Implementation Science
• Other Study ID Numbers: 20230484; 1R01MH134269-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No