Statistical Methods for Adherence Issues in HIV Prevention Research

HIV 预防研究中依从性问题的统计方法

• 批准号: 9292248
• 负责人: Ying Qing Chen
• 金额: $ 63.27万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-02 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9292248
• 关键词: AIDS prevention; Address; Adherence; Agreement; Behavior Therapy; Biological; Clinical; Clinical Trials; Computer software; Coupled; Couples; Data; Data Analyses; Data Collection; Effectiveness; Electronic drug monitoring; Fumarates; Goals; Gold; HIV; HIV Infections; HIV vaccine; Health; Incidence; Individual; Intention; Kenya; Linear Regressions; Measures; Mediation; Mediator of activation protein; Methodology; Methods; Modeling; Monitor; Oral; Oral Medicine; Participant; Patient Self-Report; Pattern; Pharmaceutical Preparations; Pharmacy facility; Plasma; Population; Population Attributable Risks; Populations at Risk; Prevention; Prevention Research; Prevention trial; Preventive Intervention; Procedures; Public Health; Regimen; Research Design; Research Personnel; Risk; Role; Sampling; Statistical Methods; Tenofovir; Testing; Time; Translational Research; Treatment Efficacy; Uganda; Woman; clinical care; clinical practice; cost effective; design; drug testing; emtricitabine; flexibility; improved; innovation; instrument; mathematical model; men who have sex with men; pill; pre-exposure prophylaxis; prevent; public health relevance; social; standard measure; study population; success; time use; tool

 DESCRIPTION (provided by applicant): Recent advances in biomedical prevention intervention, e.g., Treatment as Prevention (TasP) and Pre‐ Exposure Prophylaxis (PrEP), have changed how HIV prevention is conceptualized and implemented, while effective HIV vaccine is yet to be developed. For a biological HIV prevention regimen, mostly likely in oral medicine, to be effective, users' adherence to the prescribed regimen is critical. Imperfect adherence reduces the regimen's effectiveness, and also makes it difficult to assess the regimen's efficacy in clinical trial settings. There are various instruments used in clinical practce for researchers trying to measure the adherence. Since each of these instruments has its limitations, we have realized that there is a serious lack of systematic statistical methods, being flexible and reliable to the different data collection procedures. To address the need, in this application we aim to 1) develop consistent statistical measures that can capture different longitudinal adherence patterns; 2) develop statistical methods to infer the true adherence pattern using data from different measuring instruments; 3) develop statistical methods to detect and analyze the association between the adherence patterns and the level of protection from HIV acquisition; 4) develop a statistical/mathematical modeling framework to predict the population impact of adherence improvement on a population's overall HIV incidence reduction. Upon the completion of this project, an innovative, useful and easy‐to‐implement set of statistical tools and software will be developed for assessing, analyzing and improving adherence in HIV prevention research.

 描述（由适用提供）：例如预防生物医学预防干预的最新进展，例如预防治疗（TASP）和预防预防预防（PREP），已改变了预防HIV预防和实施的方式，而有效的HIV疫苗仍在开发中。为了使生物艾滋病毒预防方案（最有可能在口腔医学中）有效，用户遵守规定的方案至关重要。不完美的依从性降低了该方案的有效性，并且也很难评估该方案在临床试验环境中的有效性。临床实践中使用了各种工具，用于试图衡量依从性的研究人员。由于这些仪器中的每一个都有其局限性，因此我们意识到严重缺乏系统的统计方法， 灵活而可靠的数据收集程序。为了满足需求，在本应用程序中，我们的目的是1）制定一致的统计措施，可以捕获不同的纵向依从性模式； 2）开发统计方法，使用来自不同测量工具的数据来推断真实的依从性模式； 3）开发统计方法来检测和分析依从性模式与艾滋病毒获取的保护水平之间的关联； 4）开发一个统计/数学建模框架，以预测依从性改善对依从性的整体HIV事件减少的影响。该项目完成后，将开发一组创新，有用且易于实施的统计工具和软件集，以评估，分析和改善HIV预防研究中的依从性。