PC4PrEP: Integrating PrEP into Primary Care

PC4PrEP：将 PrEP 纳入初级保健

基本信息

批准号：
9279244
负责人：
Laurie J Bauman
金额：
$ 94.97万
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/9279244
关键词：
AIDS/HIV problem Address Adherence Adoption Adverse effects Affordable Care Act Anal Sex Area Awareness Biological Assay Blood Caring Centers for Disease Control and Prevention (U.S.)Clinic Clinical Practice Guideline Clinical Research Collaborations Communication Communities Computerized Medical Record Counseling Eligibility Determination Epidemic FDA approved Federally Qualified Health Center Financial compensation Fumarates Funding Futility Goals Guidelines HIV HIV Infections HIV risk Health Healthcare Healthcare Systems Heterosexuals Home environment Human immunodeficiency virus test Incidence Individual Injecting drug user Institutes Insurance Intervention Interview Link Measures Medicaid Medical Medical center Medicine Modeling New York Occupations Oral Organizational Models Outcome Patient Self-Report Patients Phase Policies Positioning Attribute Prevention approach Primary Health Care Professional counselor Provider Randomized Randomized Clinical Trials Reporting Research Risk Seroprevalences Site Spottings System Tenofovir Training Support Uninsured United States National Institutes of Health Universities Woman base behavioral study college continuing medical education cost design emtricitabine evidence base high risk high risk men high risk population implementation research implementation science innovation interest men men who have sex with men multidisciplinary outreach pre-exposure prophylaxis prevention service primary care setting public health relevance screening social stigma tool transgender women truvada uptake

项目摘要

DESCRIPTION (provided by applicant): Although 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 and approved by the FDA in 2012, uptake has been limited. Significant impediments to PrEP implementation include: system barriers (lack of a medical "home" and organizational 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 and is provided to the uninsured. Primary Care for PrEP (PC4PrEP) is a new multilevel structural intervention that will address these diverse barriers to PrEP uptake in underserved communities in the Bronx, NY, a U.S HIV epicenter. It has 4 components: (1) designate a "home" for PrEP in primary care clinics; (2) train and support primary care providers (PCPs) to prescribe and manage PrEP, and create provider norms that promote the value of PrEP; (3) identify high-risk individuals in primary care clinics using a new PrEP Eligibility Tool; and (4) identify high- risk out-of-care individuals (in collaboration with a community-based organization (CBO) that conducts outreach and HIV testing in HIV-risk groups) and link them to PCPs who can provide PrEP. We will conduct a Phase 2 clinic-randomized futility trial of PC4PrEP in 6 Federally Qualified Health Centers (FQHCs) and 6 non- randomized community HIV testing sites to determine whether PC4PrEP shows promise for increasing the rate of new PrEP prescriptions, assess its effect on outcomes at each stage of our conceptualization of the "PrEP Cascade," and assess challenges to PrEP adoption. The Specific Aims are to (1) assess whether PC4PrEP shows promise, measured as the rate of new PrEP prescriptions per clinic per year; (2) through a phased implementation of PC4PrEP components, determine the incremental contribution of each component; (3) evaluate the effects of PC4PrEP on measures of the "PrEP Cascade"; and (4) assess challenges to PC4PrEP adoption through (a) in-depth interviews with PCPs and support staff about PC4PrEP; (b) in-depth interviews with selected patient-provider dyads to understand their communication about PrEP; and (c) a nested longitudinal qualitative study of patients who initiate PrEP that will include exploration of risk compensation and self-reported adherence augmented by an objective measure of adherence, dried blood spot assays for tenofovir disphosphate. If shown effective, PC4PreP will be highly transferable to other primary care clinic/CBO partnerships in high HIV incidence communities. It is consistent with CDC Guidelines and the Patient Protection and Affordable Care Act in integrating PrEP into primary care practices and is responsive to the 2014 NYS Health Department guidelines, which position PrEP as a first-line intervention for high-risk groups.

描述（由适用提供）：尽管已证明口服预防预防（PREP）可有效减少与男性发生性关系的高风险男性，异性活跃的男性和男性的艾滋病毒感染，并在2012年被FDA注射吸毒者并在2012年批准了FDA，但吸收受限。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的组织模型）；提供者的障碍（难以确定可能从准备，对PREP的经验不足以及对依从性和风险补偿的担忧的困难）；和用户障碍（缺乏对准备的意识，无法访问适合处方准备的提供者以及对污名和副作用的担忧）。成本不是纽约州的障碍，在纽约州，包括医疗补助在内的许多保险计划涵盖了PREP，并提供给了未投保的保险。 PREP的初级保健（PC4PREP）是一种新的多级结构干预措施，该干预措施将解决这些潜水员的障碍，以在美国纽约州布朗克斯市服务不足的社区（美国艾滋病毒中心）中提供准备。它有4个组成部分：（1）指定在初级保健诊所的“住所”；（2）培训和支持初级保健提供者（PCP）来准备和管理PREP，并创建促进PREP价值的提供商规范；（3）使用新的PREP资格工具在初级保健诊所中识别高风险个体；（4）确定高风险的出现外在的人（与基于社区的组织（CBO）在艾滋病毒风险群体中进行外展和艾滋病毒测试，并将其链接到可以提供PREP的PCP。我们将在6个联邦资格的健康中心（FQHC）和6个非随机社区HIV测试站点中对PC4PREP进行第二阶段临床机械化的能源试验，以确定PC4PREP是否表现出有望提高新的预处方率是否有望提高其对我们对套餐的概念的影响，并评估“预定”的概念，并进行了cascade的概念，并进行了cascade挑战，以做出挑战，“和评估挑战”。具体目的是（1）评估PC4PREP是否表现出希望，以每年每个诊所的新准备处方率衡量；（2）通过分阶段实现PC4PREP组件，确定每个组件的增量贡献；（3）评估PC4PREP对“准备级联”测量的影响；（4）通过（a）对PCP的深入访谈和支持人员对PC4PREP的深入访谈，对PC4PREP采用PC4PREP的挑战；（b）对选定的患者支持者的二元组的深入访谈，以了解他们对准备的沟通；（c）对启动PREP的患者进行嵌套的纵向定性研究，其中包括探索风险补偿和自我报告的依从性，并通过客观的依从性测量，替诺福韦过磷酸盐的血液点测定。如果显示有效，则PC4PREP将高度转移到高艾滋病毒发病率社区的其他初级保健诊所/CBO合作伙伴关系中。它与CDC指南以及将PREP纳入初级保健实践的《 CDC指南》一致，并且对2014年纽约州卫生部门指南响应，该指南将PREP作为对高风险群体的一线干预措施。