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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Completion Rate of HRSN Screener | Baseline; Month 4; Month 8; Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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
For CBO Partner participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
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:
Exclusion Criteria:
For Patient participant group: An individual who meets any of the following criteria will be excluded from participation in this 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
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:
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There are multiple participant groups:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Pitts, MD | Contact | 301-318-4376 | robert.pitts@nyulangone.org | |
| Ofole Mgbako | Contact | 646-501-9758 | Ofole.mgbako@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Pitts, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYC Health + Hospitals/Bellevue | Recruiting | New York | New York | 10016 | United States | |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Requests should be directed to Robert.pitts@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
Immediately following publication. No end date.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose (individual participant data meta-analysis) will be granted access. Requests should be directed to Robert.pitts@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| 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 | Percentage of patients who remain on PrEP. | Baseline; Month 4; Month 8; Month 12 |
| Retention in HIV Prevention Care | Percentage of patients who are retained in HIV prevention care. | Baseline; Month 4; Month 8; Month 12 |
| NYU Langone Health |
| Recruiting |
| New York |
| New York |
| 10016 |
| United States |