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NCT Number: NCT06062342

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

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.

Recruiting

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Sannisha Dale, PhD

CONTACT

[email protected]

(305) 243-6714

Sannisha Dale, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FPI

Behavioral

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 outcomes

  1. Change in number of residents with recent HIV testing

    Time frame: 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

    Time frame: 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

    Time frame: Baseline and up to 23 months

    Will be reported as the proportion of residents that indicated 'Yes' on the survey.

Secondary outcomes

  1. Change in condom use as measured by Five Point Initiative - Community Survey

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 23 months

    Number of residents with PrEP prescription by each of the participating health organizations.

Study contacts

Contact information is provided by the study sponsor or research team.

SHINE Research Program

CONTACT

[email protected]

Sannisha Dale, PhD

CONTACT

[email protected]

(305) 243-6714

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: FPI

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Oct 2, 2023
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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