Health Outcomes/Cost of Early vs Delayed ART in Haiti

描述（由申请人提供）：关于在资源有限的环境中开始抗逆转录病毒治疗（ART）的最佳时间存在争议。Serena Koenig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，他的研究目标是确定在海地有症状的艾滋病毒疾病患者中启动ART的最佳时间，使用决策建模方法将临床益处，毒性风险和财务成本之间的复杂权衡结合起来。她将进行拟议的健康结果研究，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，以比较早期与延迟治疗艾滋病前症状性艾滋病患者的生存率和结核病结果。她将由苏·戈尔迪博士、沃伦·约翰逊博士和让·威廉·佩普博士指导。本研究计划由三个具体目标组成：1.测量临床试验中早期和延迟治疗组患者的生活质量和抗逆转录病毒治疗依从性，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价值。2.使用在GHESKIO和海地其他地方治疗的患者的临床试验数据和回顾性数据，对海地的艾滋病毒护理进行成本分析。这项分析将估计早期与延迟ART的初始、诱导和避免的医疗资源成本。从社会角度对海地早期与延迟抗逆转录病毒疗法进行成本效益分析。结果指标将包括预期寿命、终生直接医疗总费用以及每获得质量调整生命年和残疾调整生命年的成本效益。结果将根据是否存在活动性结核（TB）感染进行分层，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.