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(申请人提供)：尽管口服暴露前预防(PrEP)已被证明在减少高危男性、异性恋活跃的男性和男性以及注射吸毒者中的艾滋病毒感染方面有效，并于2012年获得FDA的批准，但吸收受到限制。实施PrEP的重大障碍包括：制度障碍(缺乏实施PrEP的医疗“家”和组织模式)；提供者障碍(难以确定哪些人可能从PrEP中受益，缺乏PrEP经验，以及对遵守和风险补偿的担忧)；以及用户障碍(对PrEP缺乏认识，无法接触到愿意开PrEP的提供者，以及对耻辱和副作用的担忧)。在纽约州，费用并不是障碍，在纽约州，PrEP由包括医疗补助在内的许多保险计划覆盖，并提供给未参保的人。PrEP初级保健(PC4PrEP)是一种新的多层次结构性干预措施，将解决美国艾滋病毒中心纽约布朗克斯区服务不足的社区感染PrEP的这些不同障碍。它包括4个组成部分：(1)为初级保健诊所的PrEP指定“家”；(2)培训和支持初级保健提供者(PCP)开出和管理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危个人；以及(4)识别高危失业者(与 在艾滋病毒风险群体中进行外展和艾滋病毒检测的社区组织(CBO)，并将他们与能够提供预防接种计划的初级保健医生联系起来。我们将在6个联邦合格卫生中心(FQHC)和6个非随机社区艾滋病毒检测地点进行PC4PrEP的第二阶段临床随机无效性试验，以确定PC4PrEP是否显示出提高新PrEP处方率的前景，评估其在我们概念化“PrEP级联”的每个阶段对结果的影响，并评估PrEP采用面临的挑战。具体目标是(1)评估PC4PrEP是否显示出希望，以每个诊所每年新开PrEP处方的比率衡量；(2)通过分阶段实施PC4PrEP组件，确定每个组件的增量贡献；(3)评估PC4PrEP对“PrEP级联”措施的影响；以及(4)通过(A)深入访谈PCP和支持人员，评估采用PC4PrEP面临的挑战；(B)对选定的患者-提供者双方进行深入访谈，以了解他们关于PrEP的沟通；以及(C)对发起PrEP的患者进行嵌套的纵向定性研究，其中将包括探索风险补偿和自我报告的依从性，并增加客观的依从性衡量标准，以及替诺福韦二磷酸的干血斑分析。如果证明有效，PC4PreP将高度可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。它在将PrEP纳入初级保健实践方面符合CDC指南和患者保护和平价医疗法案，并响应了2014年纽约卫生部指南，该指南将PrEP定位为高危群体的一线干预措施。