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Catch A Vibe - 24-00864

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07116629
Enrollment
343
Registered
2025-08-11
Start date
2025-10-22
Completion date
2028-05-01
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health-Related Social Needs

Keywords

LAI-PrEP, Community Partnerships, Health-Related Social Needs

Brief 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.

Interventions

None listed

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

For Patient participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria: * 18 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: * 18 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: * 18 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: * 18 years of age or older * Declines LAI-PrEP as part of standard of care * Capacity and willingness to provide consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Completion Rate of HRSN ScreenerBaseline; Month 4; Month 8; Month 12

Secondary

MeasureTime frameDescription
Percentage of Participants who Identify Financial Insecurity as an HRSNBaseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Transportation as an HRSNBaseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Food Insecurity as an HRSNBaseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Legal Assistance as an HRSNBaseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Housing Insecurity and/or Homelessness as an HRSNBaseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Inadequate Housing as an HRSNBaseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Education as an HRSNBaseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Employment as an HRSNBaseline; Month 4; Month 8; Month 12
Percentage of Participants who Childcare Issues as an HRSNBaseline; Month 4; Month 8; Month 12
PrEP PersistenceBaseline; Month 4; Month 8; Month 12Percentage of patients who remain on PrEP.
Retention in HIV Prevention CareBaseline; Month 4; Month 8; Month 12Percentage of patients who are retained in HIV prevention care.

Countries

United States

Contacts

CONTACTRobert Pitts, MD
robert.pitts@nyulangone.org301-318-4376
CONTACTOfole Mgbako
Ofole.mgbako@nyulangone.org646-501-9758
PRINCIPAL_INVESTIGATORRobert Pitts, MD

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026