Catch A Vibe: Connecting LAI-PrEP patients with community support to address health-related social needs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study aims to scale up screening for health-related social needs at regular provider visits every four months for individuals on LAI-PrEP. It uses patient navigation and formal connections with two community-based organizations to link participants to resources. An EMR-based tracking system will monitor referrals and outcomes to assess implementation success. The focus is on Black/Latine cisgender women, Black/Latine men who have sex with men, and transgender or nonbinary individuals, with participation open to eligible patients and staff at NYU Langone Health and NYC Health + Hospitals/Bellevue.

Why it matters

Who can join: the full rules

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

Where it's running

• NYC Health + Hospitals/Bellevue
  New York, New York, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Robert Pitts, MD — NYU Langone Health
• Study coordinator: Robert Pitts, MD
• Email: robert.pitts@nyulangone.org
• Phone: 301-318-4376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.