NCT07116629 · NYU Langone Health
Catch A Vibe - 24-00864
What this study is 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).
View original scientific description
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.
Primary outcome measures
Completion Rate of HRSN Screener
Time frame: Baseline; Month 4; Month 8; Month 12
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Clinical Pharmacist
- 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
- Clinical Pharmacist
- 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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations