Health Outcomes/Cost of Early vs Delayed ART in Haiti

描述(由申请人提供)：在资源有限的情况下，关于开始抗逆转录病毒治疗(ART)的最佳时间存在争议。塞雷娜·凯尼格博士是布里格姆妇女医院社会医学和健康不平等部门的传染病研究员和副医生，她的研究目标是使用决策建模方法确定在海地有症状的艾滋病毒疾病患者中启动抗逆转录病毒治疗的最佳时间，以纳入临床益处、毒性风险和财务成本之间的复杂权衡。她将在进行拟议的健康结果研究的同时，进行一项随机对照试验，该试验将由太子港的GHESKIO研究中心进行，以比较艾滋病前期症状艾滋病毒疾病患者早期治疗和延迟治疗的存活率和结核病结果。她将得到苏·戈尔迪、沃伦·约翰逊和让·威廉·帕普博士的指导。这项研究计划由三个具体目标组成：1.在临床试验中测量早期和延迟治疗组患者的生活质量和对抗逆转录病毒治疗的依从性，并对患者和海地社区其他成员进行访谈研究，比较他们在艾滋病毒疾病不同阶段对健康的重视程度。2.利用在GHESKIO和海地其他地方接受治疗的患者收集的临床试验数据和回顾数据，对海地艾滋病毒护理进行成本分析。这项分析将估计早期抗逆转录病毒治疗与延迟抗逆转录病毒治疗在一段时间内的初始、诱导和避免的医疗资源成本。3.从社会角度对海地早期抗逆转录病毒治疗与延迟抗逆转录病毒治疗进行成本效益分析。结果衡量标准将包括预期寿命、终身直接医疗总成本，以及每获得质量调整寿命年和残疾调整寿命年的成本效益。结果将根据活动性结核病(TB)感染的存在与否进行分层，敏感性分析将检查依从率的影响。

DESCRIPTION (provided by applicant): There is debate regarding the optimal time to initiate antiretroviral therapy (ART) in resource-limited settings. The research goal of Dr. Serena Koenig, an infectious disease fellow and associate physician in the Division of Social Medicine and Health Inequalities at Brigham and Women's Hospital, is to determine the optimal time to initiate ART in patients with symptomatic HIV disease in Haiti using a decision modeling approach to incorporate complex trade-offs among clinical benefits, risk of toxicity, and financial cost. She will carry out the proposed health outcomes study in parallel with a randomized control trial that will be conducted by the GHESKIO research center in Port au Prince to compare survival and TB outcomes for early versus delayed treatment of patients with pre-AIDS symptomatic HIV disease. She will be mentored by Drs. Sue Goldie, Warren Johnson, and Jean William Pape. This research plan is composed of three specific aims: 1. To measure quality of life and adherence to ART among patients in the early and delayed treatment groups in the clinical trial, and to conduct an interview study of patients and other members of the Haitian community to compare the values they place on health at different stages of HIV disease. 2. To perform a cost analysis of HIV care in Haiti using clinical trial data and retrospective data collected on patients treated at GHESKIO and elsewhere in Haiti. This analysis will estimate the initial, induced, and averted costs of health-care resources over time for early versus delayed ART. 3. To conduct a cost-effectiveness analysis of early versus delayed ART in Haiti from a societal perspective. Outcome measures will include life expectancy, lifetime total direct medical costs, and costeffectiveness in dollars per quality-adjusted life-year gained and in disability-adjusted life-year gained. Results will be stratified based on the presence or absence of active tuberculosis (TB) infection and sensitivity analyses will examine the impact of adherence rates.