Clinical trial NCT06062342: Five Point Initiative: A Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities
Official title: Five Point Initiative: A Cluster Randomized Trial of a Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Keywords: HIV prevention
HIV testing
PrEP
Implementation Science
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-10-02
Enrollment: 20400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a stepped wedge trial and all zip codes cross over from pre-assessment period (control) to active intervention. The time/order in which zip codes enter the stepped wedge is the unity of randomization.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in number of residents with recent HIV testing
timeFrame: Up to 23 months
measure: Change in number of residents with PrEP prescription
timeFrame: Up to 23 months
measure: Change in PrEP knowledge as measured by Five Point Initiative - Community Survey
timeFrame: Baseline and up to 23 months
Secondary outcomes:
measure: Change in condom use as measured by Five Point Initiative - Community Survey
timeFrame: Baseline and up to 23 months
measure: Change in condom access as measured by Five Point Initiative - Community Survey
timeFrame: Baseline and up to 23 months
measure: Proportion of residents with recent HIV testing by health organizations
timeFrame: Up to 23 months
measure: Number of residents with PrEP prescription by health organizations
timeFrame: Up to 23 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sannisha Dale, PhD
role: PRINCIPAL_INVESTIGATOR
References: