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

摘要 最近提出的结束艾滋病毒流行(EHE)倡议包括四大支柱：诊断、治疗、保护、 并做出回应。涉及EHE倡议的“响应”支柱的研究可能与障碍有关 由于一系列相关的科学、伦理、法律和社会因素，其他三个支柱没有得到遵守 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。这项提议将迈出创新的一步，解决 一系列潜在的ME信息HIV预防努力的伦理、法律和社会影响(ELSI) 通过模拟开发，使用真实世界数据进行参数化，并结合当前和新兴的 技术和分析方法。这些定量的估计将有助于我们努力理解 与ME相关的道德、法律和社会问题，以及指导政策制定以减少相关担忧 敬他们。这项拟议的研究题为《关键人群对分子药物风险和益处的看法 艾滋病毒预防流行病学(HIV-ME)“将使全国艾滋病毒携带者(PLWH)人群参与进来 和无艾滋病毒的高危人群(PWoH)在多方法检查中的ELSI的ME-通知推论 (即，识别具有基因关联的艾滋病毒序列的个人)，以促进成功实施 我指导的艾滋病毒预防研究。关键人群，包括与男性发生性关系的男性，变性人 妇女和在EHE倡议优先考虑的地理区域注射毒品的人将被包括在内。 定量和定性方法将通过良好的效益估计(例如，改进的)来提供信息 通过分子监测进行风险分层)和风险(例如，推断的传播方向性和错误 身份识别)源自对美国一次典型的艾滋病毒流行的模拟。到目前为止，还没有 全面努力提供与ME相关的实际风险和收益的量化估计- 在美国妇幼保健院和妇幼保健院开展艾滋病预防干预，目前还没有大规模的 关键人群的参与，以确定如何感知这些风险和好处。此外，没有 以前的研究集中在艾滋病毒负担较高的司法管辖区。 我们的首要目标是评估ME方法在艾滋病毒预防研究中的可接受性 全美PLWH和PWoH的人口，通过对风险和 福利。我们将确定可能影响受艾滋病毒-ME影响最大的人的促进者和障碍，并制定 提高ME指导的HIV预防研究可接受性的指导。要做到这一点，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、法律和社会风险 预防；2)目标2--估计分子流行病学的可测量的科学益处和风险；以及3) 目标3-为设计和实施涉及分子的研究制定考虑和指导要点 流行病学--预防艾滋病毒的知情方法。

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.