PC4PrEP: Integrating PrEP into Primary Care

PC4PrEP：将 PrEP 纳入初级保健

基本信息

批准号：
9324506
负责人：
Laurie J Bauman
金额：
$ 26.32万
依托单位：
ALBERT EINSTEIN COLLEGE OF MEDICINE, INC
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-05-27 至 2020-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9324506
关键词：
AIDS prevention AIDS/HIV problem Acquired Immunodeficiency Syndrome Address Adherence Adoption Adverse effects Affordable Care Act Anal Sex Area Awareness Behavior Biological Assay Biological Markers Blood Caring Centers for Disease Control and Prevention (U.S.)Clinic Clinical Clinical Practice Guideline Clinical Research Communities Community Health Centers Computerized Medical Record Counseling Country Data Data Sources Development Eligibility Determination Epidemic Evaluation Federally Qualified Health Center Financial compensation Fumarates Futility Goals Guidelines HIV HIV Infections Health Healthcare Healthcare Systems Heterosexuals Home environment Human immunodeficiency virus test Incidence Individual Injecting drug user Institutes Insurance Intervention Interview Link Longitudinal Surveys Measures Medicaid Medical Medical center Medicine Methods Modeling New York Occupations Oral Organizational Models Outcome Patient Self-Report Patients Phase Population Positioning Attribute Prevention Prevention approach Primary Health Care Process Professional counselor Prophylactic treatment Protocols documentation Provider Qualitative Methods Randomized Randomized Clinical Trials Recommendation Reporting Research Risk Seroprevalences Services Site Spottings Staging System Tenofovir Testing Universities Woman base behavioral study college condoms continuing medical education cost design emtricitabine evidence base falls health disparity high risk interest men men who have sex with men multidisciplinary programs screening social stigma tool transgender women truvada uptake

项目摘要

DESCRIPTION (provided by applicant): Oral pre-exposure prophylaxis (PrEP) has been proven effective in reducing HIV infection in high-risk men who have sex with men, heterosexually active women and men, and injecting drug users. Despite its 2012 approval by the FDA and the development of CDC clinical guidelines, PrEP uptake has been limited. Significant impediments to PrEP implementation include: system barriers (lack of a medical "home" and of models for implementing PrEP); provider barriers (difficulty identifying those likely to benefit from PrEP, inexperience with PrEP, and concerns about adherence and risk compensation); and user barriers (lack of awareness of PrEP, inability to access providers comfortable with prescribing PrEP, and concerns about stigma and side effects). Cost is not a barrier in New York State, where PrEP is covered by many insurance plans, including Medicaid. Primary Care for PrEP (PC4PrEP) is a structural, multilevel intervention that will integrate PrEP into primary care practices that care for underserved communities in the Bronx, NY, an epicenter of continuing HIV infection in the US. The proposed study is closely aligned with the goals of the Patient Protection and Affordable Care Act in expanding high-quality coordinated primary care in community health centers and integrating HIV/AIDS prevention and treatment services into primary care. PC4PrEP will develop an organizational protocol for prescribing PrEP in primary care; identify high-risk individuals in primary care clinics and community HIV testing sites using a new PrEP Eligibility Tool; link them to primary care providers (PCPs) who can provide PrEP; and counsel potential users about PrEP both before they receive a prescription (to enhance receptivity), and after they initiate PrEP (to enhance adherence). In the course of this study, we will (1) develop and pilot PC4PrEP; (2) implement and evaluate it in "real-world" settings (Federally Qualified Health Centers; FQHCs) on objective outcomes as well as provider and patient reports; and (3) present a new model, the PrEP Cascade that - as with the HIV Care Cascade for HIV+ populations - may be used to evaluate the impact of PrEP programs in the US and other countries. PC4PrEP is consistent with CDC and NYSDOH Guidelines and the Affordable Care Act in integrating PrEP into primary care practices and is responsive to recent 2014 NYSDOH recommendations which now position PrEP as a first-line intervention for MSM and transgender women who engage in ongoing condomless anal sex, HIV- partners in sero-discordant relationships, and high-risk heterosexual women in high seroprevalence areas. There are two Specific Aims: (1) Finalize the PC4PrEP intervention and, in a clinic-randomized Phase 2 futility trial, assess whether it shows promise for increasing PrEP prescription rates in the Bronx, NY; and (2) Identify strengths and limitations of PC4PrEP in two ways: (a) through a mixed-methods process evaluation PrEP-eligible patients and PCPs, counselors and navigators; and (b) by identifying "fall-off" at each step of the PrEP Cascade.

描述（通过应用程序提供）：已证明口服预防前预防（PREP）有效地减少与男性发生性关系，异性恋活跃的男性和男性以及注射吸毒者的高风险男性的艾滋病毒感染。尽管FDA获得了2012年的批准和CDC临床准则的制定，但PREP吸收仍受到限制。预备实施的重大障碍包括：系统障碍（缺乏医疗“家庭”和实施PREP的模型）；提供者障碍（难以确定可能受益于准备，对准备的不足以及对依从性和风险补偿的担忧）；和用户障碍（缺乏对准备的意识，无法访问对处方准备的提供者以及对污名和副作用的担忧）。费用不是纽约州的障碍，在纽约州，包括医疗补助在内的许多保险计划涵盖了PREP。 PREP的初级保健（PC4PREP）是一种结构性的多级干预措施，将PREP整合到纽约州布朗克斯市服务不足的社区的初级保健实践中，这是美国持续HIV感染的震中。拟议的研究与《患者保护和负担得起的护理法》的目标紧密一致，以扩大社区卫生中心的高质量协调初级保健，并将艾滋病毒/艾滋病预防和治疗服务整合到初级保健中。 PC4PREP将开发一个组织协议，以开处方初级保健中的PREP；使用新的PREP资格工具在初级保健诊所和社区艾滋病毒测试站点中识别高风险的人；将它们链接到可以提供PREP的初级保健提供者（PCP）；并在收到处方（增强受体）和启动PREP（增强依从性）之后，在他们收到处方之前的PREP咨询。在这项研究的过程中，我们将（1）开发和驾驶PC4PREP；（2）在“现实世界”设置（联邦合格的保健中心； FQHC）中对其进行实施和评估，以及提供者和患者报告；（3）提出了一种新模型，即与艾滋病毒+人群的艾滋病毒护理级联级联一样，可以用来评估美国和其他国家 /地区的准备计划的影响。 PC4PrEP is consistent with CDC and NYSDOH Guidelines and the Affordable Care Act in integrating PrEP into primary care practices and is responsive to recent 2014 NYSDOH recommendations which now position PrEP as a first-line intervention for MSM and transgent women who engage in ongoing condomless anal sex, HIV- partners in sero-discordant relationships, and high-risk heterosexual women in high seroprevalence areas.有两个具体的目的：（1）最终确定PC4PREP干预措施，并且在诊所2阶段2能量试验中，评估它是否显示出有望提高纽约州布朗克斯市的准备处方率；（2）通过两种方式确定PC4PREP的优势和局限性：（a）通过混合方法评估预先资格的患者以及PCP，伙伴和导航器；（b）通过在准备级联的每个步骤中识别“损坏”。