Catch A Vibe - 24-00864
- Conditions
- Health-Related Social Needs
- Registration Number
- NCT07116629
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 343
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
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Completion Rate of HRSN Screener Baseline; Month 4; Month 8; Month 12
- Secondary Outcome Measures
Name Time Method Percentage of Participants who Identify Financial Insecurity as an HRSN Baseline; Month 4; Month 8; Month 12 Percentage of Participants who Identify Transportation as an HRSN Baseline; Month 4; Month 8; Month 12 Percentage of Participants who Identify Food Insecurity as an HRSN Baseline; Month 4; Month 8; Month 12 Percentage of Participants who Identify Legal Assistance as an HRSN Baseline; Month 4; Month 8; Month 12 Percentage of Participants who Identify Housing Insecurity and/or Homelessness as an HRSN Baseline; Month 4; Month 8; Month 12 Percentage of Participants who Identify Inadequate Housing as an HRSN Baseline; Month 4; Month 8; Month 12 Percentage of Participants who Identify Education as an HRSN Baseline; Month 4; Month 8; Month 12 Percentage of Participants who Identify Employment as an HRSN Baseline; Month 4; Month 8; Month 12 Percentage of Participants who Childcare Issues as an HRSN Baseline; Month 4; Month 8; Month 12 PrEP Persistence Baseline; Month 4; Month 8; Month 12 Percentage of patients who remain on PrEP.
Retention in HIV Prevention Care Baseline; Month 4; Month 8; Month 12 Percentage of patients who are retained in HIV prevention care.
Trial Locations
- Locations (2)
NYC Health + Hospitals/Bellevue
🇺🇸New York, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
NYC Health + Hospitals/Bellevue🇺🇸New York, New York, United States