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

Not Applicable

Recruiting

• Conditions: Hiv
• Interventions: Behavioral: FPI

• Registration Number: NCT06062342
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-10-02
• Study Start: 2024-02-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2028-12-01
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States