Optimizing HIV Therapy: virological monitoring, adherence & cost-effectiveness

优化 HIV 治疗：病毒学监测、依从性

• 批准号: 8528384
• 负责人: Sarah E. Rutstein
• 金额: $ 3.73万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-17 至 2017-07-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8528384
• 关键词: AIDS clinical trial group; Address; Adherence; Africa; Africa South of the Sahara; African; Algorithms; Ancillary Study; Area; Automobile Driving; Awareness; Bedside Testings; Behavior; Behavioral; Behavioral Research; Biological; Blood; Care Technology Points; Clinical; Clinical Research; Clinical Trials; Cohort Studies; Cost Effectiveness Analysis; Counseling; Country; Data; Decision Making; District Hospitals; Economics; Effectiveness; Enrollment; Ensure; Epidemiology; Evaluation; Failure; Fellowship; Fostering; Goals; Guidelines; HIV; HIV therapy; Individual; Knowledge; Literature; Malawi; Medicine; Mentorship; Modeling; Monitor; Morbidity - disease rate; Motivation; National Research Service Awards; Outcome; Patient Monitoring; Patients; Persons; Pharmaceutical Preparations; Physicians; Policies; Policy Maker; Preparation; Price; Provider; Public Health; Quality of Care; Quality of life; Regimen; Reporting; Research; Research Design; Research Methodology; Research Project Grants; Resistance; Resistance development; Resources; Risk; Role; Scientist; Secondary to; Series; Severity of illness; Spottings; Sustainable Development; Techniques; Testing; Therapeutic; Training; Translational Research; Treatment Effectiveness; Treatment Efficacy; Treatment Failure; Treatment outcome; Viral; Viral Load result; Viremia; Virus; antiretroviral therapy; behavioral health; career; cohort; compliance behavior; cost effective; cost effectiveness; design; effective intervention; empowered; evidence base; improved; innovation; insight; mortality; point of care; policy implication; predictive modeling; programs; prospective; resistance mutation; resistant strain; response; scale up; skills; standard of care; therapy adherence; therapy outcome; therapy resistant; transmission process

DESCRIPTION (provided by applicant): Antiretroviral therapy (ART) has enormous benefits for HIV-infected persons, including improved morbidity and mortality and reduced secondary transmissions. In sub-Saharan Africa, rapid scale-up of ART has allowed over four million persons to receive therapy. Maximizing treatment outcomes in these persons requires sufficient adherence and appropriate regimen selection. Viral load (VL) monitoring is one approach that has been underutilized in Africa, but has the potential to enhance long-term outcomes. Expanded monitoring may be critical to improving adherence, maintaining treatment efficacy, preserving therapeutic options, and controlling emerging resistant strains. Behaviorally, VL monitoring may be a potent motivator to improve adherence. The VL communicates important information to the patient regarding the threat of increasing severity of disease. Knowledge of an increased VL is a warning sign that may improve a patient's adherence behavior. For persons with resistance mutations, simple algorithms are needed to guide decisions and ensure prompt conversion to second-line therapy to minimize poor outcomes and transmission of resistant virus. Cost-effective interventions to maximize ART effects must consider the role of adherence and resistance in driving outcomes. Comprehensive cost-effectiveness analyses provide insight for policymakers considering implementation of monitoring strategies, addressing the consequences of early initiation of ART on a larger scale. The overall objective of this Kirschstein-NRSA individual fellowship (F30) proposal is to identify the clinical and policy implications of VL monitoring in sub-Saharan Africa, facilitating the development of sustainable, cost-effective ART monitoring to maximize treatment outcomes. The specific aims of this proposal are: 1) To evaluate the effect of providing VL information on ART adherence; 2) To develop a predictive model to identify persons with resistance from a single elevated VL; and 3) To develop a generalizable cost-effectiveness model to a) compare point-of-care, DBS, and conventional VL monitoring to current standard of care, and b) conduct optimization evaluation for design and pricing of forthcoming point-of-care tests. The proposed research includes an ancillary study of a prospective cohort study designed to examine the effect of VL information on ART adherence (Aim 1); a retrospective analysis of RCT data to improve efficiency in identifying treatment failure (Aim 2); and a generalizable cost-effectiveness analysis to inform VL monitoring policy (Aim 3). Through this research project and a carefully constructed training plan, the trainee will achieve the following fellowship goals: 1) develop advanced skills in econometric, clinical, and behavioral research methods; 2) acquire clinical and translational research skills; and 3) develop professional skills necessary to foster a successful academic career.

描述（由申请人提供）：抗逆转录病毒疗法（ART）对感染HIV的人具有巨大的好处，包括提高的发病率和死亡率以及降低了继发性传播。在撒哈拉以南非洲，迅速扩大艺术使超过400万人接受治疗。最大化这些人的治疗结果需要足够的依从性和适当的方案选择。病毒载荷（VL）监测是一种在非洲未充分利用的方法，但有可能提高长期结局。扩展的监测可能对于提高依从性，维持治疗效果，保留治疗选择和控制新兴抗性菌株至关重要。 从行为上讲，VL监视可能是提高依从性的有效动机。 VL向患者传达有关疾病严重程度日益严重的威胁的重要信息。对VL增加的知识是一个警告信号，可以改善患者的依从性行为。对于具有阻力突变的人，需要简单的算法来指导决策并确保迅速转化为二线治疗，以最大程度地减少抗抗病病毒的不良预后和传播。 具有成本效益的干预措施以最大化艺术作用，必须考虑依从性和抵抗力在推动结果中的作用。全面的成本效益分析为考虑实施监测策略的决策者提供了见解，以解决更大范围的早期艺术开始的后果。这项Kirschstein-NRSA个人奖学金（F30）的总体目标是确定VL监测在撒哈拉以南非洲中的VL监测的临床和政策影响，从而促进了可持续的，具有成本效益的艺术监测的发展，以最大程度地提高治疗结果。 该提案的具体目的是：1）评估提供有关艺术依从性的VL信息的效果； 2）开发一个预测模型，以识别具有单个升高VL抗性的人； 3）为了将可推广的成本效益模型开发为a）比较现有的护理点，DB和常规VL监控与当前的护理标准，b）进行优化评估，以设计和定价即将出现的即将出现的即将出现的关键点测试。拟议的研究包括对一项前瞻性队列研究的辅助研究，旨在检查VL信息对艺术依从性的影响（AIM 1）；对RCT数据的回顾性分析，以提高识别治疗失败的效率（AIM 2）；和可推广的成本效益 分析以告知VL监视政策（AIM 3）。通过该研究项目和精心构建的培训计划，实习生将实现以下奖学金目标：1）发展经济学，临床和行为研究方法的先进技能； 2）获得临床和转化研究技能； 3）发展成功的学术职业所必需的专业技能。