Optimizing Outcomes for HIV-Exposed and HIV-Infected Children in South Africa

优化南非艾滋病毒暴露和感染儿童的成果

• 批准号: 8103904
• 负责人: Andrea Lynne Ciaranello
• 金额: $ 13.71万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-25 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8103904
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adolescent; Africa; Age; Age-Months; Algorithms; Award; Biological Assay; Biometry; Birth; Boston; Budgets; Caring; Cessation of life; Child; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Cohort Studies; Collaborations; Communicable Diseases; Complement; Computer Simulation; Cost Effectiveness Analysis; Data; Decision Analysis; Development; Diagnosis; Diagnostic; Diagnostic tests; Discipline; Disease; Doctor of Philosophy; Early Diagnosis; Economic Models; Epidemiologic Studies; Ethics; Evaluation; Faculty; Federal Government; Funding; Future; General Hospitals; Guidelines; HIV; HIV Infections; Health Benefit; Infant; Infection; Instruction; International; Lead; Life; Literature; Massachusetts; Mentored Research Scientist Development Award; Mentors; Mentorship; Methodology; Methods; Modeling; Morbidity - disease rate; Mothers; NIH Office of AIDS Research; Operations Research; Outcome; Perinatal; Perinatal Infection; Pharmacotherapy; Policies; Policy Maker; Prevalence; Principal Investigator; Public Health Schools; Publishing; Records; Regimen; Relative (related person); Research; Research Methodology; Research Personnel; Research Priority; Resources; Source; South Africa; Techniques; Therapeutic; Time; Toxic effect; United States National Institutes of Health; Woman; antiretroviral therapy; base; career development; clinical care; clinical decision-making; clinical effect; cost; cost effective; cost effectiveness; improved; medical schools; member; models and simulation; mortality; pediatric human immunodeficiency virus; prevent; programs; success; tool

DESCRIPTION (provided by applicant): When available and used optimally, antiretroviral therapy (ART) can dramatically reduce the morbidity and mortality associated with perinatally-acquired HIV disease. In resource-limited settings such as South Africa, however, the most effective diagnostic tests and ART regimens for the management of perinatal HIV infection are often not available. As a result, more than 60,000 perinatal infections and 20,000 pediatric HIV deaths may occur annually in South Africa alone. Clinicians and policy-makers in South Africa currently select diagnostic tests and ART regimens for children based on limited available data about efficacy, toxicity, and cost. Decision analysis can complement more traditional clinical research methods by synthesizing data from multiple sources and projecting the future outcomes of diagnostic and therapeutic strategies over the lifetimes of HIV-infected children. This K01 award application proposes three Specific Aims based on these methods: 1. To construct a Monte Carlo simulation model of perinatal HIV disease, and to use as parameters in the model the best available data in the literature and from collaborating investigators in South Africa. 2. To evaluate the long-term clinical outcomes and cost-effectiveness of ART initiation in the first year of life compared to deferred therapy. 3. To evaluate the clinical outcomes and relative cost-effectiveness of currently recommended diagnostic testing algorithms for early infant diagnosis. To facilitate this proposed research, the Candidate, Andrea Ciaranello, MD, will pursue coursework in advanced biostatistics and modeling methodology, operations research, and ethical principles pertinent to HIV/AIDS in resource-limited settings. Dr. Ciaranello will benefit from the resources of the Massachusetts General Hospital and the Harvard School of Public Health; from the support of mentors with expertise in modeling techniques, perinatal HIV infection, and international HIV research and with outstanding records of mentorship; and from her collaborations with clinical investigators in South Africa and with the international Kids' ART-LINC research consortium. This K01 Award will facilitate Dr. Ciaranello's career development and her transition to an independent HIV clinical outcomes investigator. RELEVANCE (See instructions): This K01 Award will lead to analyses that will inform clinical decisions, as well as national and international policy guidelines, regarding the management of HIV infection in children. The proposed research aligns with the published priorities of the NIH Office of AIDS research, including the evaluation of the most effective, setting-specific strategies for diagnosis, care and treatment of HIV-infected children and adolescents.

描述（由申请人提供）：抗逆转录病毒疗法（ART）在可用和最佳使用时，可显著降低围产期获得性HIV疾病相关的发病率和死亡率。然而，在南非等资源有限的环境中，往往得不到管理围产期艾滋病毒感染的最有效的诊断检测和抗逆转录病毒疗法。因此，仅在南非，每年就可能发生60 000多例围产期感染和20 000例儿童艾滋病毒死亡。南非的临床医生和政策制定者目前根据关于疗效、毒性和成本的有限可用数据为儿童选择诊断测试和ART方案。决策分析可以通过综合来自多种来源的数据，预测感染艾滋病毒儿童一生中诊断和治疗战略的未来结果，补充更传统的临床研究方法。K 01奖项申请基于这些方法提出了三个具体目标：1。构建围产期HIV疾病的Monte Carlo模拟模型，并将文献中和南非合作研究者的最佳可用数据用作模型参数。2.评价与延迟治疗相比，在出生后第一年开始ART治疗的长期临床结局和成本效益。3.评价目前推荐的用于婴儿早期诊断的诊断检测算法的临床结局和相对成本效益。为了促进这项拟议的研究，候选人，安德烈Ciaranello，医学博士，将追求先进的生物统计学和建模方法，运筹学，以及有关艾滋病毒/艾滋病在资源有限的环境伦理原则的课程。Ciaranello博士将受益于马萨诸塞州总医院和哈佛公共卫生学院的资源;受益于在建模技术、围产期艾滋病毒感染和国际艾滋病毒研究方面具有专业知识并具有出色指导记录的导师的支持;受益于她与南非临床研究人员和国际儿童ART-LINC研究联盟的合作。该K 01奖将促进Ciaranello博士的职业发展和她向独立的HIV临床结果调查员的过渡。相关性（参见说明）：该K 01奖将导致分析，为临床决策以及国家和国际政策指导方针提供信息，涉及儿童艾滋病毒感染的管理。拟议的研究与NIH艾滋病研究办公室公布的优先事项相一致，包括评估最有效的，针对艾滋病毒感染儿童和青少年的诊断，护理和治疗的具体策略。