NCT07116629招募中不适用
A Community-Based Intervention To Address Health-Related Social Needs For Patients On LAI-PrEP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 343
- 试验地点
- 4
- 主要终点
- Completion Rate of HRSN Screener
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
- •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
结局指标
主要结局
Completion Rate of HRSN Screener
时间窗: Baseline; Month 4; Month 8; Month 12
Completion Rate of HRSN Screener
时间窗: Baseline; Month 4; Month 8; Month 12
次要结局
- 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)
- Retention in HIV Prevention Care(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 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 Employment as an HRSN(Baseline; Month 4; Month 8; Month 12)
- 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)
- Retention in HIV Prevention Care(Baseline; Month 4; Month 8; Month 12)
研究者
研究点 (4)
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