PC4PrEP: Integrating PrEP into Primary Care

 描述（由申请人提供）：口服暴露前预防（PrEP）已被证明可有效减少高危男性同性性行为者、异性性行为活跃的女性和男性以及注射吸毒者的艾滋病毒感染。尽管2012年FDA批准了PrEP，并制定了CDC临床指南，但PrEP的吸收仍然有限。实施PrEP的重大障碍包括：系统障碍（缺乏医疗“家园”和实施PrEP的模式）;提供者障碍（难以识别可能存在的障碍）; 受益于PrEP，缺乏PrEP经验，以及对依从性和风险补偿的担忧）;和用户障碍（缺乏对PrEP的认识，无法访问对处方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。 PrEP初级保健（PC 4PrEP）是一种结构性的多层次干预措施，将PrEP整合到初级保健实践中，为纽约州布朗克斯服务不足的社区提供护理，该社区是美国持续艾滋病毒感染的中心。这项拟议的研究与《患者保护和平价医疗法》的目标密切一致，即在社区卫生中心扩大高质量的协调初级保健，并将艾滋病毒/艾滋病预防和治疗服务纳入初级保健。PC 4PrEP将制定一个组织协议，用于在初级保健中处方PrEP;使用新的PrEP资格工具识别初级保健诊所和社区艾滋病毒检测站点的高风险个人;将他们与可以提供PrEP的初级保健提供者（PCP）联系起来;并在收到处方之前（以提高接受性）和启动PrEP之后（以提高依从性）为潜在用户提供PrEP咨询。在这项研究的过程中，我们将（1）开发和试点PC 4PrEP;（2）在“现实世界”环境中实施和评估它（联邦合格的卫生中心; CIMCs）的客观结果以及提供者和患者的报告;（3）提出了一种新的模型，PrEP Cascade与HIV+人群的HIV Care Cascade一样，可用于评估美国和其他国家PrEP计划的影响。PC 4PrEP与CDC和NYSDOH指南和平价医疗法案一致，将PrEP纳入初级保健实践，并响应最近2014年NYSDOH的建议，该建议现在将PrEP定位为从事持续无安全套肛交的MSM和变性妇女的一线干预措施，艾滋病毒-血清不一致关系中的伴侣，以及高血清阳性率地区的高风险异性恋妇女。 有两个具体目标：（1）最终确定PC 4PrEP干预措施，并在临床随机2期无效试验中，评估其是否有望提高纽约州布朗克斯的PrEP处方率;（2）以两种方式确定PC 4PrEP的优势和局限性：（a）通过混合方法过程评估PrEP合格患者和PCP，辅导员和导航员;和（B）通过鉴定PrEP级联的每个步骤的“下降”。

 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.