Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in

快速启动抗逆转录病毒治疗以促进艾滋病毒/艾滋病的早期治疗

• 批准号: 8490297
• 负责人: Sydney Rosen
• 金额: $ 36.93万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-19 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8490297
• 关键词: AIDS prevention; AIDS/HIV problem; Acceleration; Address; Adherence; Adult; African; Bedside Testings; CD4 Lymphocyte Count; Care Technology Points; Caring; Clinic; Clinic Visits; Counseling; Creatinine clearance measurement; Diagnosis; Diagnostic tests; Dose; Drops; Early treatment; Education; Eligibility Determination; Failure; Government; HIV; HIV Infections; HIV Seropositivity; HIV diagnosis; Hemoglobin; High Prevalence; Human immunodeficiency virus test; Intention; Intervention; Laboratories; Laboratory Personnel; Medical; Modeling; Morbidity - disease rate; Outcome; Outpatients; Patient Care; Patients; Population; Pregnancy; Pregnant Women; Prevention strategy; Procedures; Public Health; Randomized; Readiness; Recommendation; Resources; Savings; Schedule; South Africa; Technology; Testing; Time; Training; Viral; Virus; Visit; antiretroviral therapy; arm; base; cost; cost effective; cost effectiveness; design; evidence base; improved; innovation; liver function; mortality; novel diagnostics; prevent; programs; research study; routine care; standard of care; transmission process; treatment program; treatment site; trial comparing; tuberculosis treatment; wasting

DESCRIPTION (provided by applicant): One of the most serious challenges facing antiretroviral therapy (ART) programs in resource-constrained settings is the failure of ART-eligible patients to complete the steps required to initiate treatment. The high rate of loss to cae of patients who are treatment-eligible at HIV diagnosis may be due in part to the large number of steps required between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In South Africa, these steps usually require 2-4 clinic visits over a perio of 2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses among those eligible for ART is to simplify and condense the steps required for starting treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and TB diagnosis are available. These technologies can be combined with changes to clinic schedules to allow all steps required for ART initiation (lab tests, medical exam, education) to take place on the day the patient presents for an HIV test. The study is designed as an unblinded randomized strategy trial comparing the current standard of care to a rapid ART initiation strategy for outpatient adults and pregnant women who come to a South African clinic for an HIV test and are eligible for ART. Those who are offered rapid ART initiation will have the chance to receive their first dose of ARVs on the same day, while those in the comparison arm of the study will follow the clinic's usual procedures for starting ART. The study aims to evaluate whether offering rapid ART initiation is an effective and cost-effective strategy for increasing th proportion of ART-eligible patients who are successfully treated, as indicated by having no virus detectable within 9 months of HIV testing. This study is significant because prior research by the study team and others has shown that losses from HIV care before ART initiation may be as high as two thirds, resulting in continued late presentation for treatment, unnecessary morbidity and mortality, and substantial wasted resources. The intervention is innovative because it combines novel diagnostic technologies in a new setting, aims to maximize treatment initiations, and considers whether the strategy is both affordable and cost effective. It is also innovative because it examines the effect of the strategy on pregnant women as well as on the general adult population. Finally, it will help to build the evidence base for "test-and-treat," one of the most innovative ideas currently considered to prevent HIV transmission.

描述（由申请人提供）：在资源受限设置中抗逆转录病毒疗法（ART）计划面临的最严重的挑战之一是符合艺术资格的患者无法完成启动治疗所需的步骤。在接受HIV诊断的符合治疗资格的患者的CAE损失率很高可能部分是由于接受HIV诊断和获得首次剂量抗逆转录病毒（ARV）所需的大量步骤。在南非，这些步骤通常需要在患者开始治疗的2-8周内进行2-4个诊所就诊。提出的一种减少有资格获得艺术的损失的策略是简化和凝结开始治疗所需的步骤。这是可能的，因为可以提供新的，即时的CD4计数和结核病诊断测试。这些技术可以与诊所时间表的更改结合使用，以允许在患者提出HIV测试的那天进行艺术启动所需的所有步骤（实验室测试，体检，教育）。该研究被设计为一项无盲的随机策略试验，将目前的护理标准与为门诊成人和孕妇的快速艺术启动策略进行了比较，他们来南非诊所进行HIV测试，并有资格获得艺术。那些被提供快速艺术启动的人将有机会在同一天接受第一剂ARV，而研究的比较部门将遵循该诊所的通常的开始艺术的程序。该研究旨在评估 提供快速艺术启动是一种有效且具有成本效益的策略，用于增加成功治疗的符合艺术资格的患者的比例，如在HIV测试后9个月内无法检测到的病毒所表明的那样。这项研究很重要，因为研究团队和其他人的先前研究表明，在艺术启动之前，艾滋病毒护理的损失可能高达三分之二，从而导致治疗，不必要的发病率和死亡率以及大量浪费资源的延迟呈现。干预具有创新性，因为它将新颖的诊断技术结合在新环境中，旨在最大化治疗启动，并考虑该策略是否负担得起且具有成本效益。它也具有创新性，因为它检查了该战略对孕妇以及一般成年人口的影响。最后，这将有助于建立“测试和治疗”的证据基础，其中之一 目前认为最具创新性的想法是为了防止艾滋病毒传播。