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: 8540744
• 负责人: SERENA Patricia KOENIG
• 金额: $ 66.32万
• 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/8540744
• 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）：大多数在资源匮乏的环境中新诊断为艾滋病毒的患者在开始抗逆转录病毒治疗（ART）之前就失去了护理。然而，目前的协议强加治疗延迟，需要多次ART前访问的ART扫盲咨询和医疗评估，以评估机会性感染（OI）。如果能够在一天之内提供这些服务，护理的保留率将得到改善，因为在艾滋病毒检测和开始抗逆转录病毒治疗之间每增加一步，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ART前阶段的服务，并改善护理保留对于全球艾滋病毒计划的成功至关重要。必须在财力和人力资源有限的情况下考虑这些战略。拟议的研究是一项随机试验，旨在确定在海地太子港GHESKIO中心进行即时CD 4细胞检测的免疫学标准（CD 4细胞计数d350细胞/mm 3）符合ART资格的早期HIV临床疾病（世界卫生组织[WHO] 1期或2期）HIV检测患者当天开始ART的有效性。干预组的所有患者将接受快速HIV抗体检测、即时CD 4细胞检测、临床相关检测， OIs、WHO分期、综合咨询和社会支持，以及就诊当天的ART启动。标准组将接受与当天ART组相同的服务（包括床旁CD 4细胞检测），但他们将接受标准GHESKIO方案，即在开始ART前进行三次连续访视，以进行ART准备咨询和OI检测，而不是当天ART。对于当天ART组，这些活动将在ART启动当天和随后的两周内进行。提出了三个具体目标。第一个目的是比较标准和同一天ART组中存活和在HIV检测后12个月无法检测到HIV病毒载量的患者比例。第二个目的是比较两组之间的抗逆转录病毒治疗依从性使用药房续药记录。第三个目的是比较标准和当天ART的成本和成本效益，其中成本是通过平均治疗成本来衡量的，有效性是通过在艾滋病毒检测后12个月内病毒载量检测不到的情况下存活和护理来衡量的。2012年跨NIH艾滋病毒相关研究计划优先考虑评估创新方法的临床影响和成本效益的研究，以吸引和留住艾滋病毒治疗的个人。这项研究的结果将影响全世界的护理，因为在所有情况下，新诊断的艾滋病毒患者中有很大一部分在ART开始前失访。