New methods for the design and evaluation of large HIV prevention interventions

设计和评估大型艾滋病毒预防干预措施的新方法

• 批准号: 8729765
• 负责人: DONNA L SPIEGELMAN
• 金额: $ 67.18万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8729765
• 关键词: AIDS prevention; Address; Africa; Africa South of the Sahara; Area; Attenuated; Botswana; Cellular Phone; Clinical Trials Design; Collaborations; Communities; Computer software; Data; Data Analyses; Development; Discipline; Disease; Effectiveness; Ethics; Evaluation; HIV; HIV Infections; HIV prevention trial; HIV prevention trials network; Health; Human Resources; Impact evaluation; Incidence; Intervention; Interviewer; Investigation; Libraries; Measurement; Methodology; Methods; Modeling; Observational Study; Outcome; Performance; Population; Prevention; Prevention Research; Preventive Intervention; Principal Investigator; Proxy; Randomized; Randomized Clinical Trials; Recommendation; Research; Research Design; Research Personnel; Robin bird; Science; South Africa; Statistical Methods; Stratification; Structural Models; Tanzania; Testing; Time; Uncertainty; Vertical Disease Transmission; Work; Zambia; antiretroviral therapy; base; comparative effectiveness; cost; cost effectiveness; design; experience; follow-up; improved; models and simulation; novel; novel strategies; prevent; prevention clinical trial; prevention evaluation; programs; randomized trial; scale up; social; tool; transmission process; treatment center; user-friendly; validation studies; web site

DESCRIPTION (provided by applicant): The advent of newly discovered efficacious tools for the prevention of HIV creates a new challenge and the need for new paradigms: How do we assess the impact of combinations of HIV prevention tools in ethical ways, when we have evidence that individually they work to reduce HIV transmission? How do we roll out efficacious strategies, but assess their effectiveness and cost-effectiveness in real-world settings at scale? In a powerful collaboration between four of the major HIV preventive interventions currently underway - including Harvard's Botswana Community Prevention Project and Familia Salama study of PMTCT, Vanderbilt and Imperial's PopART project, and the Africa Centre's Treatment as Prevention trial, our proposal, entitled "New methods for the design and evaluation of large HIV prevention interventions" will address key gaps in the available methodologies for the design and analysis of these large- scale HIV preventive intervention projects. After extensive dialogue with the Principal Investigators and other key personnel on these projects (three of whom are Co-investigators of this proposal), we have identified our specific aims as: 1) To develop and validate novel network methods to improve the evaluation of large combination prevention clinical trials 2) To develop advanced statistical methods to improve the design and evaluation of large- scale HIV prevention studies. 3) To augment prevention trial designs to adjust for bias due to loss to follow-up and to assess infectiousness and indirect effects. 4) To disentangle and evaluate the effects of specific interventions that comprise a 'package' as in the Harvard-Botswana and HPTN 061/PopART trials

描述(申请人提供)：新发现的预防艾滋病毒的有效工具的出现带来了新的挑战和对新范式的需要：当我们有证据表明艾滋病毒预防工具单独有效地减少艾滋病毒传播时，我们如何以伦理方式评估艾滋病毒预防工具组合的影响？我们如何推出有效的战略，同时在现实世界中大规模评估其有效性和成本效益？在目前正在进行的四项主要艾滋病毒预防干预措施--包括哈佛的博茨瓦纳社区预防项目和防止母婴传播的Familia Salama研究、Vanderbilt和Imperial的PopART项目--与非洲中心的治疗作为预防试验之间的有力合作中，我们题为“设计和评估大型艾滋病毒预防干预措施的新方法”的提案将解决这些大规模艾滋病毒预防干预项目设计和分析的现有方法中的主要空白。在与这些项目的首席研究人员和其他关键人员(其中三人是本提案的共同研究人员)进行了广泛的对话后，我们确定了我们的具体目标：1)开发和验证新的网络方法，以改进大型联合预防临床试验的评估；2)开发先进的统计方法，以改进大规模艾滋病毒预防研究的设计和评估。3)加强预防试验设计，调整失访偏倚，评估感染性和间接效应。4)如哈佛-博茨瓦纳试验和HPTN 061/PopART试验中那样，理清和评估构成“一揽子”的特定干预措施的效果