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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hiv

Intervention / Treatment
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* Behavioral: FPI


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FPI Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, HIV testing, PrEP, Implementation Science