Catch A Vibe - 24-00864
A Community-Based Intervention To Address Health-Related Social Needs For Patients On LAI-PrEP
NYU Langone Health
343 participants
Oct 22, 2025
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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07116629