Recruiting

LAI-PrEP

Sponsor:

NYU Langone Health

Code:

NCT07116629

Conditions

Health-Related Social Needs

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Health-Related Social Needs

Study ID

NCT07116629

Start date

Oct 22, 2025

Status verified date

Jun, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

343 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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

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

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

Primary outcome measure

  • Completion Rate of HRSN Screener [ Time Frame: Baseline; Month 4; Month 8; Month 12 ]

Central Contacts and Locations

Locations

NYC Health + Hospitals/Bellevue

Recruiting

New York, New York, United States, 10016

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-26.