Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care

当日艾滋病毒检测和治疗启动，以提高护理保留率

• 批准号: 8623097
• 负责人: SERENA Patricia KOENIG
• 金额: $ 61.15万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-02-19 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8623097
• 关键词: Adherence; Bedside Testings; CD4 Lymphocyte Count; CD4 Positive T Lymphocytes; Caring; Cells; Clinical; Counseling; Critical Care; Disease; Effectiveness; Ensure; Evaluation; Guidelines; HIV; HIV Antibodies; HIV-1; Haiti; Human Resources; Human immunodeficiency virus test; Immunologics; Individual; Investigation; Measures; Medical; Mission; Newly Diagnosed; Opportunistic Infections; Outcome; Participant; Pathway interactions; Patients; Pharmacy facility; Plasma; Protocols documentation; Public Health; Qualifying; RNA; Readiness; Records; Research; Resources; Services; Social support; Staging; Testing; Treatment Cost; Treatment Effectiveness; United States National Institutes of Health; Viral Load result; Visit; World Health Organization; antiretroviral therapy; clinically relevant; cost; cost effective; cost effectiveness; follow-up; group intervention; improved; innovation; literacy; point of care; programs; public health relevance; randomized trial; standard care; success; therapy adherence; treatment program

DESCRIPTION (provided by applicant): The majority of patients that are newly diagnosed with HIV in resource-poor settings are lost to care prior to initiation of antiretroviral therapy (ART). Yet current protocols impose delays in therapy by requiring multiple pre-ART visits for ART literacy counseling and medical evaluations to assess for opportunistic infections (OIs). Retention in care would be improved if these services could be provided in one day, as the rate of attrition increases with every additional step between HIV testing and ART initiation. Efforts t implement and evaluate strategies that strengthen linkages between HIV testing and treatment programs, streamline services during the pre-ART period, and improve retention in care are critical to the success of HIV programs worldwide. Such strategies must be considered in the context of constrained financial and human resources. The proposed study is a randomized trial to establish the effectiveness of same-day ART initiation for patients who present for HIV testing with early HIV clinical disease (World Health Organization [WHO] stage 1 or 2) who qualify for ART by immunologic criteria (CD4 cell count d350 cells/mm3) with point-of-care CD4 cell testing at the GHESKIO Center in Port-au-Prince, Haiti. All patients in the intervention group will receive rapid HIV antibody testing, point-of-care CD4 cell testing, clinically relevant testing for OIs, WHO staging, comprehensive counseling and social support, and ART initiation on the day of presentation. The standard group will receive the same services as the same-day ART group (including point-of-care CD4 cell testing) except that instead of same-day ART, they will receive the standard GHESKIO protocol of three sequential visits for ART readiness counseling and testing for OIs prior to ART initiation. For the same-day ART group, these activities will take place on the day of ART initiation and during the subsequent two weeks. Three specific aims are proposed. The first aim is to compare the proportion of patients in the standard and same-day ART groups that are alive and in-care with an undetectable HIV viral load at 12 months after HIV testing. The second aim is to compare ART adherence between the two groups using pharmacy refill records. The third aim is to compare the cost and cost-effectiveness of standard and same-day ART, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with an undetectable viral load at 12 months after HIV testing. The 2012 Trans-NIH Plan for HIV-Related Research prioritizes investigations that evaluate the clinical impact and cost-effectiveness of innovative approaches to engage and retain individuals in HIV treatment. The results of this study will impact care worldwide, as a substantial proportion of patients with newly diagnosed HIV are lost to follow-up before ART initiation in all settings.

描述(由申请人提供)：在资源匮乏的环境中新诊断为艾滋病毒的大多数患者在开始抗逆转录病毒治疗(ART)之前失去了护理。然而，目前的方案通过要求多次ART前探视进行艺术素养咨询和医学评估来评估机会性感染(OIS)，从而延误了治疗。如果能在一天内提供这些服务，护理保留率将得到改善，因为在艾滋病毒检测和抗逆转录病毒治疗开始之间，每增加一步，自然减员率就会增加。努力实施和评估加强艾滋病毒检测和治疗计划之间联系的战略，简化抗逆转录病毒治疗前的服务，并改善护理的保留，对于全球艾滋病毒项目的成功至关重要。必须在财政和人力资源有限的情况下考虑这些战略。这项拟议的研究是一项随机试验，旨在为那些在海地太子港的GHESKIO中心接受艾滋病病毒检测的患者(世界卫生组织(WHO)第1或2期)建立当天启动抗逆转录病毒治疗的有效性，这些患者通过免疫学标准(CD4细胞计数d350细胞/mm3)通过护理点CD4细胞测试获得抗逆转录病毒治疗的资格。干预组中的所有患者将接受快速艾滋病毒抗体检测、护理点CD4细胞检测、临床相关检测 OIS、WHO分期、全面咨询和社会支持，以及介绍当天的ART启动。标准组将获得与当天抗逆转录病毒治疗组相同的服务(包括护理点CD4细胞检测)，不同之处在于，他们将接受标准的GHESKIO方案，即在抗逆转录病毒治疗开始之前，为OIS提供三次连续的抗逆转录病毒治疗准备咨询和检测。对于同一天的艺术团体，这些活动将在艺术印心当天和随后的两周内进行。提出了三个具体目标。第一个目标是比较标准抗逆转录病毒治疗组和同一天抗逆转录病毒治疗组中在艾滋病毒检测后12个月未检测到艾滋病毒病毒载量的活着和正在接受治疗的患者的比例。第二个目的是使用药房再灌装记录来比较两组患者对ART的依从性。第三个目标是比较标准抗逆转录病毒疗法和同日抗逆转录病毒疗法的成本和成本效益，其中成本是通过平均治疗成本衡量的，有效性是通过在艾滋病毒检测后12个月活着并在无法检测到的病毒载量的情况下接受护理来衡量的。2012年跨国立卫生研究院艾滋病毒相关研究计划将评估创新方法的临床影响和成本效益的调查列为优先事项，以吸引和留住个人参与艾滋病毒治疗。这项研究的结果将影响世界各地的护理，因为在所有环境下，新诊断的艾滋病毒患者中有相当一部分在开始抗逆转录病毒治疗之前失去了随访。