Risks, Benefits, and Stakeholder Perspectives of Molecular Epidemiology for HIV Prevention (HIV-ME)

摘要 最近提出的终止艾滋病毒流行倡议包括四个支柱：诊断、治疗、保护， 并作出回应。涉及教育、健康和环境倡议"回应"支柱的研究可能与障碍有关 由于一系列相关的科学、伦理、法律的和社会因素， 挑战EHE研究应用的成功将取决于仔细解决 这一预防战略的实施挑战。这项提案将采取创新性的飞跃， 一系列潜在的ME知情艾滋病毒预防工作的伦理、法律的和社会影响（ELSI） 通过模拟开发，使用真实数据进行参数化，并将当前和新兴的 技术和分析方法。这些定量估计将为我们了解 与ME相关的伦理、法律的和社会问题，并指导政策制定，以减轻与ME相关的问题。 给他们.这项拟议的研究，"关键人群对分子生物学风险和益处的看法"， 艾滋病毒预防流行病学（HIV-ME）"将使全国艾滋病毒感染者（PLWH）参与 和无艾滋病毒风险的人（PWoH）在ME知情推断的ELSI的多方法检查中 (i.e.,识别带有遗传连锁的艾滋病毒序列的个人），以促进成功实施 ME指导的艾滋病毒预防研究。关键人群，包括男男性行为者、变性人 将包括教育保健倡议优先考虑的地理区域内的妇女和注射毒品者。 定量和定性方法将通过充分表征的获益估计（例如，改进 通过分子监测的风险分层）和风险（例如，推断的传播方向性和错误 识别）来自一个良好表征的美国艾滋病毒流行病的模拟。到目前为止，还没有一个 全面努力提供与ME相关的实际风险和受益的定量估计- 知情的艾滋病毒预防干预PLWH和PWOH在美国，并没有大规模的 关键人群的参与，以确定如何看待这些风险和利益。此外，没有 以前的研究集中在艾滋病毒负担高的司法管辖区。 我们的总体目标是衡量在艾滋病预防研究中， 美国各地的PLWH和PWoH人群，通过对风险的充分表征估计， 效益我们将确定可能影响受HIV-ME影响最严重的人的促进因素和障碍，并制定 提高ME指导的HIV预防研究的可接受性的指导。为此，我们将解决以下问题 具体目标：1）目标1-确定艾滋病毒分子流行病学的伦理、法律的和社会风险 目的2-评估分子流行病学可衡量的科学效益和风险;以及3） 目标3-为设计和实施涉及分子生物学的研究制定考虑要点和指南 流行病学知情的艾滋病毒预防方法。

ABSTRACT The recently proposed Ending the HIV Epidemic (EHE) Initiative includes four pillars: Diagnose, Treat, Protect, and Respond. Research that involves the “Respond” pillar of the EHE Initiative may be associated with barriers not observed with the other three EHE pillars, due to a set of associated scientific, ethical, legal and social challenges. The success of EHE research applications will be contingent upon carefully addressing the implementation challenges of this prevention strategy. This proposal will take the innovative leap of addressing the Ethical, Legal and Social Implications (ELSI) of an array of potential ME-informed HIV prevention efforts developed by simulations, parameterized using real-world data, and incorporating current and emerging technological and analytic approaches. These quantitative estimates will inform our efforts to understand the ethical, legal, and social issues related to ME, as well as guide policy development to attenuate concerns related to them. The proposed study, “Perspectives Among Key Populations of the Risks and Benefits of Molecular Epidemiology for HIV Prevention (HIV-ME)” will engage a national population of persons living with HIV (PLWH) and persons at risk without HIV (PWoH) in a multi-method examination of the ELSI of ME-informed inferences (i.e., identification of individuals with genetically linked HIV sequences) to facilitate successful implementation of ME-guided HIV prevention research. Key populations, including men who have sex with men, transgender women, and persons who inject drugs in geographic areas prioritized by the EHE initiative will be included. Quantitative and qualitative methods will be informed by well-characterized estimates of benefit (e.g., improved risk stratification by molecular surveillance) and risk (e.g., inferred directionality of transmission and false identification) derived from simulations of a well characterized U.S. HIV epidemic. To date, there has not been a comprehensive effort to provide quantitative estimates of the actual risks and benefits associated with ME- informed HIV prevention interventions among PLWH and PWoH in the U.S. and there has been no large-scale engagement of key populations to determine how these risks and benefits are perceived. Furthermore, no previous studies focus on high HIV burden jurisdictions. Our overarching goal is to gauge the acceptability of ME approaches for HIV prevention research among key populations of PLWH and PWoH across the US, informed by well-characterized estimates of the risks and benefits. We will identify the facilitators and barriers that may impact those most affected by HIV-ME and develop guidance to improve acceptability of ME guided HIV prevention research. To do so we will address the following Specific Aims: 1) AIM 1 - Identify the perceived ethical, legal and social risks of molecular epidemiology for HIV prevention; 2) AIM 2 - Estimate the measurable scientific benefits and risks of molecular epidemiology; and 3) AIM 3 - Develop points to consider and guidance for designing and implementing research involving molecular epidemiology-informed approaches to HIV prevention.