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

NCT ID: NCT06062342

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2029-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

FPI

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sannisha K Dale

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sannisha Dale, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sannisha Dale, PhD

Role: CONTACT

sdale@med.miami.edu

(305) 243-6714

SHINE Research Program

Role: CONTACT

shineresearch@miami.edu

Facility Contacts

Sannisha Dale, PhD

Role: primary

sdale@med.miami.edu

(305) 243-6714

Other Identifiers

1R01MH134269-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20230484

Identifier Type: -

Identifier Source: org_study_id