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）：在开始抗逆转录病毒疗法（ART）之前，大多数在资源贫困环境中新诊断为艾滋病毒的患者都会丢失。然而，当前的方案通过需要多次进行艺术素养咨询和医学评估来评估机会性感染（OIS）来延迟治疗。如果可以在一天之内提供这些服务，随着艾滋病毒测试和艺术启动之间的每一个额外步骤的增加，保留保留将得到改善。努力实施和评估策略，以加强艾滋病毒测试和治疗计划之间的联系，在艺术前时期简化服务以及改善护理的保留措施对于全球艾滋病毒计划的成功至关重要。在财务和人力资源受限的背景下，必须考虑此类策略。 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.干预组中的所有患者将接受快速HIV抗体测试，护理点CD4细胞测试，临床相关测试 OIS，在演讲当天进行，全面的咨询和社会支持以及艺术启动。标准组将获得与当天艺术组相同的服务（包括保健CD4细胞测试），除非当日艺术，但他们将在艺术启动之前获得三个顺序访问的标准Gheskio协议。对于当天艺术团体，这些活动将在艺术当天以及随后的两周内举行。提出了三个具体目标。第一个目的是比较在HIV测试后12个月内，在标准和当日艺术组中与无法检测到的HIV病毒负荷的患者的比例。第二个目的是使用药房补充记录比较两组之间的艺术依从性。第三个目的是比较标准和当天艺术的成本和成本效益，在这种情况下，通过平均治疗成本和有效性来衡量成本是通过活着和在HIV测试后12个月内使用未发现的病毒负荷来衡量的。 2012年针对HIV相关研究的Trans-NIH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，以吸引和保留个人接受HIV治疗。这项研究的结果将影响全球护理，因为在所有情况下，在ART启动之前，新诊断的HIV的患者中很大一部分都会失去随访。