Recruiting

FPI Bundled Implementation

Sponsor:

University of Miami

Code:

NCT06062342

Conditions

Hiv

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

FPI

Study Details

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 ID

NCT06062342

Start date

Feb 2, 2024

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

20400 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

no intervention: 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.

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.

Primary outcome measure

  • Change in number of residents with recent HIV testing [ Time Frame: Up to 23 months ]
  • Change in number of residents with PrEP prescription [ Time Frame: Up to 23 months ]
  • Change in PrEP knowledge as measured by Five Point Initiative - Community Survey [ Time Frame: Baseline and up to 23 months ]

Central Contacts and Locations

Central contacts

Sannisha Dale, PhD

(305) 243-6714sdale@med.miami.edu

SHINE Research Program

shineresearch@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Sannisha Dale, PhD

(305) 243-6714sdale@med.miami.edu

Principal Investigator:

Sannisha Dale, PhD

More Information

Sponsor

University of Miami

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • HIV prevention
  • HIV testing
  • PrEP
  • Implementation Science

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-28.