RecruitingNCT07116629

Catch A Vibe - 24-00864

A Community-Based Intervention To Address Health-Related Social Needs For Patients On LAI-PrEP


Sponsor

NYU Langone Health

Enrollment

343 participants

Start Date

Oct 22, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study evaluates a proposed community-based implementation strategy to scale up screening, identification, and intervention on Health-Related Social Needs (HRSN) among persons on Long-Acting Injectable Pre-exposure Prophylaxis (LAI-PrEP). To do so, (1) screening for HRSN will occur at provider visits every 4 months, (2) navigation and establishment of connections with community resources through collaboration with two established community-based organization (CBO) partners, and (3) development of a tracking system integrated into the Electronic Medical Record (EMR) for monitoring and assessment of referral outcomes.


Eligibility

Min Age: 18 Years

Inclusion Criteria26

  • For Patient participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
  • years of age or older
  • Does not have HIV AND vulnerable for HIV infection per WHO, NHS, and CDC recommendations
  • On or initiating LAI-PrEP as part of standard of care prior to study participation
  • Identify as either a Black/Latine cisgender woman OR Black/Latine MSM OR Transgender or Nonbinary Individual
  • Capacity and willingness to provide consent
  • For Medical Staff participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
  • years of age or older
  • Works with patients who go to the Bellevue Pride Center
  • Be employed at NYU Langone Health or NYC H+H/Bellevue as one of the following occupations
  • Physician
  • Clinical Pharmacist
  • Nurse
  • Medical Phlebotomist
  • Social Worker/Navigator
  • Community Health Worker
  • Medical Leader (i.e., director of services)
  • For CBO Partner participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
  • years of age or older
  • Works with patients who go to the Bellevue Pride Center
  • Be employed at one of the established CBOs
  • Capacity and willingness to provide consent
  • For Patient Who Declines LAI-PrEP participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
  • years of age or older
  • Declines LAI-PrEP as part of standard of care
  • Capacity and willingness to provide consent

Exclusion Criteria25

  • For Patient participant group: An individual who meets any of the following criteria will be excluded from participation in this study:
  • Less than 18 years old
  • Known HIV seropositive status or test positive at screening
  • Does not identify as one of the listed priority populations
  • Not fluent in either English or Spanish
  • Not interested in HIV PrEP
  • Not willing to consent for study participation
  • Does not reside within New York State
  • Pregnant or planning to become pregnant at the time of consent.
  • Without capacity to consent to participate in the study
  • For Medical Staff participant group: An individual who meets any of the following criteria will be excluded from participation in this study:
  • Do not work with patients who go to the Bellevue Pride Center
  • Is not employed at NYU Langone Health or NYC/H+H Bellevue as one of the following occupations
  • Physician
  • Clinical Pharmacist
  • Nurse
  • Medical Phlebotomist
  • Social Worker
  • Community Health Worker
  • Medical Leader (i.e., directors of services)
  • For CBO Partner participant group: An individual who meets any of the following criteria will be excluded from participation in this study:
  • Does not work with patients who go to the Bellevue Pride Center
  • For Patient Who Declines LAI-PrEP participant group: An individual who meets any of the following criteria will be excluded from participation in this study:
  • Less than 18 years old
  • Interested in initiating LAI-PrEP as part of standard of care or on LAI-PrEP

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Locations(2)

NYC Health + Hospitals/Bellevue

New York, New York, United States

NYU Langone Health

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07116629