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）对艾滋病毒感染者具有巨大的益处，包括改善发病率和死亡率并减少继发性传播。在撒哈拉以南非洲地区，抗逆转录病毒疗法的迅速推广已使超过 400 万人接受了治疗。最大限度地提高这些人的治疗效果需要足够的依从性和适当的治疗方案选择。病毒载量（VL）监测是一种在非洲未得到充分利用的方法，但有潜力提高长期结果。扩大监测对于提高依从性、维持治疗效果、保留治疗选择和控制新出现的耐药菌株可能至关重要。 在行为上，VL 监测可能是提高依从性的有效动力。 VL 向患者传达有关疾病严重程度增加的威胁的重要信息。了解 VL 增加是一个警告信号，可以改善患者的依从行为。对于携带耐药突变的人，需要简单的算法来指导决策并确保迅速转换为二线治疗，以尽量减少不良结果和耐药病毒的传播。 为最大限度地提高 ART 效果而采取的具有成本效益的干预措施必须考虑坚持和抵抗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战略的政策制定者提供了见解，解决了早期大规模启动抗逆转录病毒疗法的后果。 Kirschstein-NRSA 个人研究金 (F30) 提案的总体目标是确定撒哈拉以南非洲 VL 监测的临床和政策影响，促进可持续、具有成本效益的 ART 监测的发展，以最大限度地提高治疗效果。 该提案的具体目标是： 1）评估提供 VL 信息对 ART 依从性的影响； 2) 开发预测模型来识别对单次升高的 VL 产生耐药性的人； 3) 开发一个通用的成本效益模型，以 a) 将护理点、DBS 和传统 VL 监测与当前护理标准进行比较，以及 b) 对即将推出的护理点的设计和定价进行优化评估测试。拟议的研究包括一项前瞻性队列研究的辅助研究，旨在检查 VL 信息对 ART 依从性的影响（目标 1）；对 RCT 数据进行回顾性分析，以提高识别治疗失败的效率（目标 2）；和普遍的成本效益 分析为 VL 监测政策提供信息（目标 3）。通过这个研究项目和精心构建的培训计划，学员将实现以下奖学金目标：1）发展计量经济学、临床和行为研究方法方面的高级技能； 2）获得临床和转化研究技能； 3）培养成功学术生涯所需的专业技能。