PC4PrEP: Integrating PrEP into Primary Care

PC4PrEP：将 PrEP 纳入初级保健

• 批准号: 9305426
• 负责人: Laurie J Bauman
• 金额: $ 85.02万
• 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/9305426
• 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

 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(由申请人提供)：口服暴露前预防(PrEP)已被证明在减少高危男男性行为、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方面有效。尽管2012年FDA批准了PrEP，并制定了CDC临床指南，PrEP的吸收一直是有限的。实施PrEP的重大障碍包括：体制障碍(缺乏医疗“家”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，担心遵守和风险补偿)；用户障碍(对PrEP缺乏认识，无法接触到对PrEP处方感到满意的提供者，以及对耻辱和副作用的担忧)。在纽约州，成本并不是障碍，那里的PrEP由包括医疗补助在内的许多保险计划覆盖。PrEP初级保健(PC4PrEP)是一种结构性、多层次的干预措施，将PrEP整合到初级保健实践中，以照顾纽约州布朗克斯区服务不足的社区，布朗克斯区是美国艾滋病毒持续感染的中心。拟议的研究与《患者保护和平价医疗法案》的目标密切一致，即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纳入初级保健。PC4PrEP将制定一个组织协议，用于在初级保健中开出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地点的高危个人；将他们与能够提供PrEP的初级保健提供者(PCP)联系起来；并在潜在用户收到处方之前(以提高接受度)和在他们启动PrEP之后(以加强遵从性)，就PrEP向他们提供咨询。在这项研究过程中，我们将(1)开发和试行PC4PrEP；(2)根据客观结果以及提供者和患者报告，在“现实世界”环境(联邦合格健康中心；FQHC)中实施和评估；(3)提出一个新模型，即PrEP级联，与针对HIV+人群的HIV关怀级联一样，可用于评估美国和其他国家的PrEP计划的影响。PC4PrEP在将PrEP纳入初级保健实践方面符合CDC和NYSTOH指南以及《平价医疗法案》，并回应了最近2014年NYSHOH的建议，这些建议现在将PREP定位为从事持续无避孕套肛交的MSM和变性人、血清不和谐关系中的艾滋病毒伴侣以及血清阳性率高地区的高危异性恋妇女的一线干预措施。有两个具体目标：(1)最终确定PC4PrEP干预措施，并在临床随机第二阶段无效性试验中，评估它是否显示出在纽约州布朗克斯提高PrEP处方率的前景；以及(2)通过两种方式确定PC4PrEP的优势和局限性：(A)通过混合方法评估符合PrEP条件的患者和PCP、咨询师和导航员；以及(B)确定PrEP级联的每一步的“下降”。