Catch A Vibe - 24-00864

Official title

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

Overview

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]

Secondary outcome measures (11)

• Percentage of Participants who Identify Financial Insecurity as an HRSN [Time frame: Baseline; Month 4; Month 8; Month 12]
• Percentage of Participants who Identify Transportation as an HRSN [Time frame: Baseline; Month 4; Month 8; Month 12]
• Percentage of Participants who Identify Food Insecurity as an HRSN [Time frame: Baseline; Month 4; Month 8; Month 12]
• Percentage of Participants who Identify Legal Assistance as an HRSN [Time frame: Baseline; Month 4; Month 8; Month 12]
• Percentage of Participants who Identify Housing Insecurity and/or Homelessness as an HRSN [Time frame: Baseline; Month 4; Month 8; Month 12]
• Percentage of Participants who Identify Inadequate Housing as an HRSN [Time frame: Baseline; Month 4; Month 8; Month 12]
• Percentage of Participants who Identify Education as an HRSN [Time frame: Baseline; Month 4; Month 8; Month 12]
• Percentage of Participants who Identify Employment as an HRSN [Time frame: Baseline; Month 4; Month 8; Month 12]
• Percentage of Participants who Childcare Issues as an HRSN [Time frame: Baseline; Month 4; Month 8; Month 12]
• PrEP Persistence [Time frame: Baseline; Month 4; Month 8; Month 12]
• Retention in HIV Prevention Care [Time frame: Baseline; Month 4; Month 8; Month 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Ecologic or community

Study locations

United States · 2 centers

• NYC Health + Hospitals/Bellevue — New York
• NYU Langone Health — New York

Identifiers

NCT: NCT07116629 · 24-00684

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗