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HIV流行（EHE）倡议的倡议包括四个支柱：诊断，治疗，保护， 并回应。涉及EHE计划的“响应”支柱的研究可能与障碍有关 由于一组相关的科学，道德，法律和社会 挑战。 EHE研究应用程序的成功将取决于仔细解决 实施这种预防策略的挑战。该提议将采取创新的飞跃来解决 一系列潜在潜在的艾滋病毒预防努力的道德，法律和社会影响（ELSI） 通过模拟开发，使用现实世界数据进行参数化，并结合了电流和新兴 技术和分析方法。这些定量估计将为我们了解 与我有关的道德，法律和社会问题，以及指导政策制定以减弱关注有关的问题 给他们。拟议的研究：“分子风险和益处的关键人群之间的观点 预防艾滋病毒的流行病学（HIV-ME）”将与艾滋病毒（PLWH）的全国人群互动 以及在对我了解的ELSI的多方法检查中，有没有艾滋病毒（PWOH）的人（PWOH） （即，识别具有一般链接的HIV序列的个体），以促进成功实施 我引导的艾滋病毒预防研究。关键人群，包括与男人发生性关系的男人，变性人 将包括妇女和在EHE倡议优先级的地理区域注射毒品的人。 定量和定性方法将通过良好的福利估计来告知（例如，改进 通过分子监视的风险分层）和风险（例如，推断传播方向性和假 鉴定）来自对美国艾滋病毒流行的模拟。迄今为止，还没有 全面的努力，以提供与我相关的实际风险和收益的定量估计 美国PLWH和PWOH之间的知情艾滋病毒预防干预措施，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利益。此外，不 先前的研究集中于高艾滋病毒负担管辖区。 我们的总体目标是评估我的可接受性方法，以预防艾滋病毒的预防研究 全美国的PLWH和PWOH人群，由良好的风险估计值和 好处。我们将确定可能影响受HIV-ME影响最大的人的促进者和障碍，并发展 提高我可接受性的指导指导HIV预防研究。为此，我们将解决以下内容 具体目的：1）目标1-确定分子流行病学对艾滋病毒的伦理，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科学益处和风险； 3） 目标3-开发要考虑的要点和指导，以设计和实施涉及分子的研究 艾滋病毒预防的流行病学方法。