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

Hiv Clinical Trial

— FPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062342
• Other study ID #: 20230484
• Secondary ID: 1R01MH134269-01
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: June 30, 2029

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Sannisha Dale, PhD
• Phone: (305) 243-6714
• Email: sdale[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20400
• Est. completion date: June 30, 2029
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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, laundrymat in the predominantly Black communities in Miami where the prevalence of HIV is highest, car service provider (e.g. gas station, mechanic, car wash) in predominantly Black communities in Miami where HIV prevalence is high.

Exclusion Criteria:

• Individuals who are unable to completely and fully understand the informed (verbal) consent process and the study procedures.

Related Conditions & MeSH terms

• Hiv

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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