Catch A Vibe - 24-00864

NYU Langone Health

Status: Not yet enrolling

Conditions: Health-Related Social Needs

Study type: Observational

Funder types: Other

Identifiers

NCT07116629

24-00684

Details and patient eligibility

About

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.

Enrollment: 343 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

343 participants in 4 patient groups

Patients on or initiating LAI-PrEP as part of standard of care

Description:

Quantitative HRSN surveys will be administered to Patient participants at enrollment, 4-, 8-, and 12-month visits to evaluate changes in HRSN, barriers/facilitators to resolving HRSN, and the impact of HRSN on LAI-PrEP persistence and retention in HIV care.

Medical Staff who work with patients on LAI-PrEP

Description:

Survey will be administered to Medical Staff participants 6 months after enrollment of the first patient participant.

CBO Partners who work with patients on LAI-PrEP linkage and addressing HRSN

Description:

Survey will be administered to community-based organization (CBO) Partner participants 6 months after enrollment of the first patient participant.

Patients who decline LAI-PrEP as part of standard of care

Description:

Survey will be administered to Patients Who Decline LAI-PrEP to better understand why they declined LAI-PrEP.