Optimizing HIV Pre-Exposure Prophylaxis through Shared Decision Making

描述(由申请人提供)：背景：由于美国61%的新艾滋病毒感染发生在男男性行为者(MSM)中，因此需要为这一人群制定有效的预防策略。抗逆转录病毒暴露前预防(PrEP)可以降低MSM中HIV的发病率，并可用于处方。然而，考虑到潜在的危害(毒性、耐药性、风险补偿)以及日常用药对生活质量的影响，识别可能受益于PrEP的MSM的风险标准尚不清楚。因此，MSM和医疗保健提供者面临决策冲突的风险，即关于PrEP使用的行动过程的不确定状态。这可能会导致决策上的后悔和执行不力。有必要了解MSM和提供商如何做出启动PrEP的决策，以及如何优化这一决策过程。候选人：我的职业目标是成为一名独立的调查员，在优化生物医学艾滋病毒预防的临床决策方面拥有专业知识。过去两年发表或提交的6篇手稿(2篇第一作者)和6篇被接受的摘要(2篇第一作者口头陈述)反映了我对艾滋病毒预防研究的承诺。要成为一名独立的调查员，我需要额外的研究培训、指导和经验。研究：我的科学目标是了解MSM和提供者是如何做出决定的，以启动PrEP，然后开发和评估决策支持干预，以优化决策过程。我的假设是，共同决策，即患者和提供者共同权衡治疗的风险和好处，然后决定行动方案的过程，可以减少决策冲突及其不利后果。我将通过追求3个具体目标来验证这一假设：1)进行定性访谈，以评估MSM和提供者如何估计HIV风险，以及如何在PrEP使用方面进行权衡，以便为共同决策辅助工具的开发提供信息；2)为MSM-提供者双方开发决策辅助工具，以减少MSM关于PrEP使用的决策冲突；以及3)评估决策辅助工具对临床环境中MSM决策冲突的影响。培训：研究由定性和定量方法、决策科学、临床试验设计、依从性措施以及与MSM研究相关的问题方面的课程和/或结构化指导支持。导师和资源：Ken Mayer博士是我的主要导师，他是MSM预防艾滋病和PrEP方面的专家。为了实现我的目标，我将利用他在芬威健康公司的广泛研究基础设施，以及哈佛大学和贝丝以色列女执事医学中心的资源，我将于2012年7月在该中心被任命为传染病科的主治医生。我还将受益于一支专注于决策科学、定性研究、患者与提供者沟通和坚守原则的共同导师团队。该方法在将临床决策科学应用于艾滋病毒预防方面具有创新性。这项研究意义重大，因为它有望从根本上改变PrEP和其他生物医学预防策略的临床决策。 公共卫生相关性：由于美国每年约50,000例新增艾滋病毒感染中有61%发生在男男性行为者(MSM)中，因此迫切需要在这一人群中采取有效的预防策略。未感染艾滋病毒的男男性男男性同性恋者使用抗逆转录病毒药物，称为暴露前预防(PrEP)，可以降低男男性同性恋者中新感染艾滋病毒的比率。然而，PrEP的使用可能与潜在的危害有关，如药物毒性、耐药艾滋病毒的出现以及危险性行为的增加。这项研究试图了解MSM个人及其医疗保健提供者如何处理围绕使用PrEP的决策的不确定性，然后开发决策支持干预以优化这一困难的决策过程。通过帮助患者做出关于PrEP使用的知情决定，这种干预可能会提高PrEP的依从性，从而最大限度地发挥这一预防战略对艾滋病毒流行的影响。

DESCRIPTION (provided by applicant): Background: As 61% of new HIV infections in the US occur among men who have sex with men (MSM), effective prevention strategies are needed for this population. Antiretroviral pre-exposure prophylaxis (PrEP) can decrease HIV incidence among MSM and is available for prescribing. However, risk criteria to identify MSM who may benefit from PrEP are unclear given potential harms (toxicities, drug resistance, risk compensation) and the impact of daily medication use on quality of life. Therefore, MSM and healthcare providers are at risk for decisional conflict, the state of uncertainty over the course f action to take, regarding PrEP use. This can lead to decisional regret and poor adherence. There is a need to understand how MSM and providers approach the decision to initiate PrEP and how to optimize this decision making process. Candidate: My career goal is to become an independent investigator with expertise in optimizing clinical decision making for biomedical HIV prevention. Six published or submitted manuscripts (2 first-author) and 6 accepted abstracts (2 first-author oral presentations) focused on PrEP in the last 2 years reflect my commitment to HIV prevention research. To become an independent investigator, I need additional research training, mentorship, and experience. Research: My scientific goal is to understand how MSM and providers approach the decision to initiate PrEP and then develop and evaluate a decision-support intervention to optimize the decision making process. My hypothesis is that shared decision making, a process in which patients and providers weigh risks and benefits of treatments together and then decide on a course of action, can reduce decisional conflict and its adverse consequences. I will test this hypothesis by pursuing 3 specific aims: 1) conduct qualitative interviews to assess how MSM and providers estimate HIV risk and approach trade-offs regarding PrEP use, in order to inform development of a shared decision making Decision Aid; 2) develop a Decision Aid for MSM-provider dyads that decreases MSM decisional conflict regarding PrEP use; and 3) evaluate the impact of the Decision Aid on MSM decisional conflict in clinical settings. Training: The research is supported by courses and/or structured mentoring in qualitative and quantitative methods, decision science, clinical trial design, adherence measures, and issues relevant to research with MSM. Mentorship and Resources: Dr. Ken Mayer, an expert in PrEP and HIV prevention for MSM, is my primary mentor. To achieve my goals, I will leverage his extensive research infrastructure at Fenway Health and the resources of Harvard and Beth Israel Deaconess Medical Center, where I will be appointed as Attending Physician in the Division of Infectious Diseases in July 2012. I will also benefit from a team of dedicated co-mentors in decision science, qualitative research, patient-provider communication, and adherence. The approach is innovative in its application of clinical decision science to HIV prevention. The research is significant because it is expected to fundamentally alter clinical decision making for PrEP and other biomedical prevention strategies. PUBLIC HEALTH RELEVANCE: As 61% of ~50,000 new HIV infections in the US each year occur among men who have sex with men (MSM), effective prevention strategies are needed urgently in this population. The use of antiretroviral medications by HIV-uninfected men MSM, known as pre-exposure prophylaxis (PrEP), can reduce the rate of new HIV infections among MSM. However, PrEP use may be associated with potential harms, such as medication toxicities, the emergence of drug resistant HIV, and increases in risky sexual behaviors. This research seeks to understand how individual MSM and their healthcare providers approach the uncertainty that surrounds the decision to utilize PrEP and then develop a decision-support intervention to optimize this difficult decision- making process. By helping patients make informed decisions regarding PrEP use, this intervention may enhance PrEP adherence and thus maximize the impact of this prevention strategy on the HIV epidemic.