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

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06062342
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 20,400
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 65.9
• Patients Per Site Per Month: 309.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hiv	Behavioral: FPI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Five Point Initiative: A Cluster Randomized Trial of a Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Dec 1, 2028
• Anticipated Study Completion Date: Jun 30, 2029

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

1. 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

2. 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

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Any individual present during the community events at the "five points" (barbershop, hair/beauty salon store or salon, corner store/grocery/neighborhood restaurant, laundromat 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Sannisha Dale, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sannisha K Dale, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT06062342
• Other Study ID Numbers: 20230484; 1R01MH134269-01
• First Posted: Oct 2, 2023
• Last Update Posted: Oct 2, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sannisha K Dale, Associate Professor, University of Miami: HIV prevention; HIV testing; PrEP; Implementation Science

Study Results

No Results Posted as of Oct 2, 2023