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: 8665872
• 负责人: Sydney Rosen
• 金额: $ 21.84万
• 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 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8665872
• 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）：在资源有限的环境中，抗逆转录病毒治疗（ART）项目面临的最严重挑战之一是符合ART条件的患者未能完成开始治疗所需的步骤。在艾滋病毒诊断时符合治疗条件的患者的死亡率很高，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之间需要经过大量步骤。在南非，这些步骤通常需要在2-8周的时间内进行2-4次诊所访问，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人的损失而提出的一项战略是简化和压缩开始治疗所需的步骤。现在这是可能的，因为有了针对CD4计数和结核病诊断的新的即时检测方法。这些技术可以与诊所时间表的变化相结合，以便在患者进行艾滋病毒检测的当天进行抗逆转录病毒治疗启动所需的所有步骤（实验室测试、医学检查、教育）。该研究被设计为一项非盲随机策略试验，将目前的护理标准与快速启动抗逆转录病毒治疗策略进行比较，这些策略适用于来南非一家诊所接受艾滋病毒检测并有资格接受抗逆转录病毒治疗的门诊成年人和孕妇。那些接受快速抗逆转录病毒治疗的人将有机会在同一天接受第一剂抗逆转录病毒药物，而那些在研究的比较组的人将遵循诊所开始抗逆转录病毒治疗的常规程序。这项研究旨在评估