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

HIV 分子流行病学预防 (HIV-ME) 的风险、益处和利益相关者观点

• 批准号: 10212958
• 负责人: SUSAN JANET LITTLE
• 金额: $ 73.77万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-08 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10212958
• 关键词: AIDS prevention; Address; Affect; Area; Attenuated; Attitude; Belief; Benefits and Risks; Centers for Disease Control and Prevention (U.S.); Communicable Diseases; Communities; Criminal Law; Data; Diagnosis; Disease Outbreaks; Epidemic; Epidemiology; Genetic; Geographic Locations; Goals; HIV; HIV Infections; Healthcare Systems; Individual; Injecting drug user; Investigation; Laboratories; Legal; Link; Measurable; Measures; Medical; Methods; Molecular; Molecular Epidemiology; Participant; Persons; Policy Developments; Population; Prevention Research; Prevention strategy; Public Health; Publications; Qualitative Methods; Reporting; Research; Research Personnel; Risk; Risk Estimate; Spottings; Surveillance Program; System; Technology; Time; United States; data sharing; deliberative democracy; design; disease transmission; epidemiologic data; ethical legal social implication; experience; implementation barriers; improved; innovation; men who have sex with men; pathogen; preventive intervention; prospective; risk stratification; simulation; social stigma; stakeholder perspectives; standard of care; success; transgender women; transmission process; working group

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.

抽象的 最近提出的结束艾滋病毒流行 (EHE) 倡议包括四个支柱：诊断、治疗、保护、 涉及 EHE 计划“响应”支柱的研究可能与障碍相关。 由于一系列相关的科学、伦理、法律和社会准则，EHE 的其他三大支柱并未得到遵守 EHE 研究应用的成功将取决于仔细解决这些挑战。 该提案将实现解决这一预防战略实施挑战的创新飞跃。 一系列潜在的基于 ME 的 HIV 预防工作的伦理、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 这些定量估计将为我们理解的努力提供信息。 与 ME 相关的道德、法律和社会问题，并指导政策制定以减轻相关担忧 拟议的研究“主要人群对分子的风险和益处的看法”。 艾滋病毒预防流行病学 (HIV-ME)”将吸引全国艾滋病毒感染者 (PLWH) 和未感染 HIV 的高危人群 (PWoH)，对 ME 知情推论的 ELSI 进行多方法检查 （即识别具有 HIV 基因序列的个体）以促进成功实施 ME引导的艾滋病毒预防研究重点人群，包括男男性行为者、跨性别者。 EHE 倡议优先考虑的地理区域中的妇女和注射吸毒者也将包括在内。 定量和定性方法将通过明确描述的效益估计（例如，改进的 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的传播方向） 识别）源自对美国艾滋病毒流行病的模拟。迄今为止，还没有出现艾滋病毒流行病。 全面努力提供与 ME-相关的实际风险和收益的定量估计 在美国，针对 PLWH 和 PWoH 的艾滋病毒预防干预措施已获悉，但尚未开展大规模的 关键人群的参与以确定如何看待这些风险和收益此外，没有。 之前的研究主要集中在艾滋病毒高负担地区。 我们的首要目标是评估 ME 方法在关键人群中对 HIV 预防研究的可接受性 通过对风险和风险的充分描述的估计，了解美国各地的 PLWH 和 PWoH 人群 我们将确定可能影响受 HIV-ME 影响最严重的人群的促进因素和障碍，并制定相关方案。 提高 ME 指导的艾滋病毒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) AIM 1 - 确定 HIV 分子流行病学的伦理、法律和社会风险 预防；2) AIM 2 - 评估分子流行病学的可衡量的科学效益和风险； AIM 3 - 制定设计和实施涉及分子研究的考虑要点和指导 基于流行病学的艾滋病毒预防方法。