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

描述(申请人提供)：在资源有限的情况下，抗逆转录病毒疗法(ART)计划面临的最严重挑战之一是符合ART条件的患者未能完成启动治疗所需的步骤。在艾滋病毒诊断中符合治疗条件的患者的CAE损失率很高，部分原因可能是在接受艾滋病毒诊断和获得第一剂抗逆转录病毒药物(ARV)之间需要大量的步骤。在南非，这些步骤通常需要在2-8周内去2-4次诊所就诊，然后患者才能开始治疗。为减少有资格接受抗逆转录病毒治疗的患者的损失而提出的一种战略是简化和压缩开始治疗所需的步骤。这现在是可能的，因为新的护理点(POC)检测CD4计数和结核病诊断是可用的。这些技术可以与临床时间表的改变相结合，使ART启动所需的所有步骤(实验室测试、体检、教育)都可以在患者进行艾滋病毒检测的当天进行。这项研究是一项非盲目随机策略试验，将目前的护理标准与快速启动ART的策略进行比较，适用于来南非诊所进行艾滋病毒检测并符合抗逆转录病毒治疗条件的门诊成年人和孕妇。那些被提供快速ART启动的患者将有机会在同一天接受他们的第一剂ARV，而那些在研究的比较组的患者将遵循诊所开始ART的通常程序。这项研究旨在评估 提供快速抗逆转录病毒疗法是否是提高符合抗逆转录病毒疗法资格的患者成功治疗的比例的有效和成本效益高的策略，如艾滋病毒检测9个月内没有检测到病毒所表明的那样。这项研究意义重大，因为研究小组和其他人之前的研究表明，在开始抗逆转录病毒治疗之前，艾滋病毒护理造成的损失可能高达三分之二，导致持续延迟提交治疗、不必要的发病率和死亡率，以及大量资源浪费。这种干预是创新的，因为它在新的环境中结合了新的诊断技术，旨在最大限度地启动治疗，并考虑该战略是否既负担得起又具有成本效益。它还具有创新性，因为它检查了该战略对孕妇以及一般成人人口的影响。最后，它将有助于建立“测试和治疗”的证据基础，这是 目前被认为是预防艾滋病毒传播的最具创新性的想法。

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.