PC4PrEP: Integrating PrEP into Primary Care

PC4PrEP：将 PrEP 纳入初级保健

• 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
• 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

 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（由申请人提供）：尽管口服暴露前预防（PrEP）已被证明可有效减少男性同性性行为高危男性、异性性行为活跃女性和男性以及注射吸毒者的艾滋病毒感染，并于2012年获得FDA批准，但使用率有限。实施PrEP的重大障碍包括：系统障碍（缺乏实施PrEP的医疗“家”和组织模式）;提供者障碍（难以识别那些可能从PrEP中受益的人，缺乏PrEP经验，以及对依从性和风险补偿的担忧）;用户壁垒（缺乏对PrEP的认识，无法获得对处方PrEP感到舒适的提供者，以及对耻辱和副作用的担忧）。在纽约州，费用并不是一个障碍，在那里，PrEP被许多保险计划所覆盖，包括医疗补助计划，并提供给没有保险的人。 PrEP初级保健（PC 4PrEP）是一种新的多层次结构性干预措施，将解决美国艾滋病中心纽约州布朗克斯服务不足社区PrEP吸收的各种障碍。它有四个组成部分：（1）在初级保健诊所为PrEP指定一个“家”;（2）培训和支持初级保健提供者（PCP）开药和管理PrEP，并创建促进PrEP价值的提供者规范;（3）使用新的PrEP资格工具识别初级保健诊所的高风险个体;以及（4）识别高风险的护理个体（与 我们将在6个联邦合格的卫生中心（CIMCs）和6个非随机社区HIV检测点进行PC 4PrEP的2期临床随机无效试验，以确定PC 4PrEP是否有望增加新PrEP处方的比例，评估其对“PrEP级联”概念化每个阶段结果的影响，并评估PrEP采用的挑战。具体目标是（1）评估PC 4PrEP是否显示出前景，以每年每个诊所新的PrEP处方率衡量;（2）通过分阶段实施PC 4PrEP组件，确定每个组件的增量贡献;（3）评估PC 4PrEP对“PrEP级联”措施的影响;和（4）通过以下方式评估采用PC 4PrEP的挑战：（a）与PCP和支持人员进行关于PC 4PrEP的深入访谈;（B）与选定的患者-提供者配对进行深入访谈，以了解他们关于PrEP的沟通;以及（c）对启动PrEP的患者进行嵌套式纵向定性研究，包括探索风险补偿和自我报告的依从性，并通过依从性的客观测量、二磷酸替诺福韦干血斑试验进行增强。如果证明有效，PC 4PreP将高度转移到艾滋病毒高发社区的其他初级保健诊所/CBO伙伴关系。它与CDC指南和患者保护和平价医疗法案一致，将PrEP纳入初级保健实践，并响应2014年纽约州卫生部指南，将PrEP定位为高危人群的一线干预措施。