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

NCT06062342 | Recruiting

• 2 other identifiers: 202304841R01MH134269-01
• Study Type: interventional
• Target: 20,400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hiv

Keywords

HIV prevention; HIV testing; PrEP; Implementation Science

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in condom use as measured by Five Point Initiative - Community Survey

  Baseline and up to 23 months

• Change in condom access as measured by Five Point Initiative - Community Survey

  Baseline and up to 23 months

• Proportion of residents with recent HIV testing by health organizations

  Up to 23 months

• Number of residents with PrEP prescription by health organizations

  Up to 23 months

Study Arms (2)

FPI Group

EXPERIMENTAL

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

Pre-intervention Assessment Group

NO 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.

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.

FPI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sannisha Dale, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sannisha Dale, PhD

CONTACT

(305) 243-6714; sdale@med.miami.edu

SHINE Research Program

CONTACT

shineresearch@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a stepped wedge trial and all zip codes cross over from pre-assessment period (control) to active intervention. The time/order in which zip codes enter the stepped wedge is the unity of randomization.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: February 2, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)