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PC4PrEP: Integrating PrEP into Primary Care

PC4PrEP：将 PrEP 纳入初级保健

基本信息

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
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/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

项目摘要

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) 已被证明可有效减少男男性行为者、异性恋活跃女性和男性以及注射吸毒者的 HIV 感染。尽管 PrEP 于 2012 年获得 FDA 批准并制定了 CDC 临床指南，但 PrEP 的使用仍然有限。 PrEP 实施的重大障碍包括：系统障碍（缺乏医疗“家园”和实施 PrEP 的模式）；提供商障碍（难以识别那些可能从 PrEP 中受益、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、无法接触到愿意开 PrEP 处方的提供者以及对耻辱和副作用的担忧）。在纽约州，费用不是障碍，PrEP 涵盖许多保险计划，包括医疗补助。 PrEP 初级保健 (PC4PrEP) 是一种结构性、多层次的干预措施，它将把 PrEP 纳入初级保健实践中，为纽约州布朗克斯区服务不足的社区提供服务，该社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 将制定初级保健中 PrEP 处方的组织协议；使用新的 PrEP 资格工具识别初级保健诊所和社区 HIV 检测点的高危人群；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（以增强接受性）和开始 PrEP 之后（以增强依从性）向潜在用户提供有关 PrEP 的建议。在本研究过程中，我们将 (1) 开发和试点 PC4PrEP； (2) 在“现实世界”环境（联邦合格健康中心；FQHC）中根据客观结果以及提供者和患者报告实施和评估它； (3) 提出一种新模型，即 PrEP 级联，与针对 HIV+ 人群的 HIV 护理级联一样，可用于评估 PrEP 计划在美国和其他国家的影响。 PC4PrEP 符合 CDC 和 NYSDOH 指南以及平价医疗法案将 PrEP 纳入初级保健实践的要求，并响应了 2014 年 NYSDOH 最近的建议，该建议目前将 PrEP 定位为一线干预措施，适用于持续进行无套肛交的 MSM 和变性女性、血清不一致关系中的 HIV 伴侣以及高血清流行地区的高风险异性恋女性。有两个具体目标：(1) 最终确定 PC4PrEP 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区的 PrEP 处方率； (2) 通过两种方式确定 PC4PrEP 的优势和局限性： (a) 通过混合方法过程评估符合 PrEP 资格的患者和 PCP、咨询员和导航员； (b) 确定 PrEP 级联每一步的“下降”。