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OpenTrials
Recruiting

NCT Number: NCT07116629

Catch A Vibe - 24-00864

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYC Health + Hospitals/Bellevue, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Completion Rate of HRSN Screener

    Time frame: Baseline; Month 4; Month 8; Month 12

Secondary outcomes

  1. Percentage of Participants who Identify Financial Insecurity as an HRSN

    Time frame: Baseline; Month 4; Month 8; Month 12

  2. Percentage of Participants who Identify Transportation as an HRSN

    Time frame: Baseline; Month 4; Month 8; Month 12

  3. Percentage of Participants who Identify Food Insecurity as an HRSN

    Time frame: Baseline; Month 4; Month 8; Month 12

  4. Percentage of Participants who Identify Legal Assistance as an HRSN

    Time frame: Baseline; Month 4; Month 8; Month 12

  5. Percentage of Participants who Identify Housing Insecurity and/or Homelessness as an HRSN

    Time frame: Baseline; Month 4; Month 8; Month 12

  6. Percentage of Participants who Identify Inadequate Housing as an HRSN

    Time frame: Baseline; Month 4; Month 8; Month 12

  7. Percentage of Participants who Identify Education as an HRSN

    Time frame: Baseline; Month 4; Month 8; Month 12

  8. Percentage of Participants who Identify Employment as an HRSN

    Time frame: Baseline; Month 4; Month 8; Month 12

  9. Percentage of Participants who Childcare Issues as an HRSN

    Time frame: Baseline; Month 4; Month 8; Month 12

  10. PrEP Persistence

    Time frame: Baseline; Month 4; Month 8; Month 12

    Percentage of patients who remain on PrEP.

  11. Retention in HIV Prevention Care

    Time frame: Baseline; Month 4; Month 8; Month 12

    Percentage of patients who are retained in HIV prevention care.

Study contacts

Contact information is provided by the study sponsor or research team.

Ofole Mgbako

CONTACT

[email protected]

646-501-9758

Robert Pitts, MD

CONTACT

[email protected]

301-318-4376

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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