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，大多数新诊断出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，目前的方案要求多次进行 ART 前就诊以进行 ART 素养咨询和医疗评估以评估机会性感染 (OIs)，从而导致治疗延迟。如果这些服务能够在一天内提供，护理的保留率将会得到改善，因为艾滋病毒检测和开始抗逆转录病毒治疗之间每增加一步，损耗率就会增加。努力实施和评估加强艾滋病毒检测和治疗计划之间联系、简化抗逆转录病毒治疗前阶段的服务以及改善护理保留率的策略，对于全球艾滋病毒计划的成功至关重要。必须在财政和人力资源有限的背景下考虑此类战略。拟议的研究是一项随机试验，目的是确定对患有早期 HIV 临床疾病（世界卫生组织 [WHO] 1 或 2 期）进行 HIV 检测的患者进行当天 ART 的有效性，这些患者根据免疫学标准（CD4 细胞计数 d350 个细胞/mm3）符合 ART 资格，并在海地太子港 GHESKIO 中心进行即时 CD4 细胞检测。干预组中的所有患者将接受快速 HIV 抗体检测、护理点 CD4 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开始 ART。标准组将接受与当天 ART 组相同的服务（包括床旁 CD4 细胞检测），只不过他们将接受标准 GHESKIO 方案，即在开始 ART 之前进行 3 次连续就诊，以进行 ART 准备咨询和 OI 测试，而不是当天进行 ART。对于当天 ART 小组，这些活动将在 ART 开始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 ART 组和当天 ART 组中在 HIV 检测后 12 个月时存活并接受护理且 HIV 病毒载量无法检测到的患者比例。第二个目标是使用药房补充记录来比较两组之间的 ART 依从性。第三个目标是比较标准 ART 和当天 ART 的成本和成本效益，其中成本通过平均治疗成本来衡量，有效性通过 HIV 检测后 12 个月时存活并处于检测不到病毒载量的护理情况来衡量。 2012 年跨 NIH 艾滋病相关研究计划优先开展调查，评估创新方法的临床影响和成本效益，以吸引和保留个人接受艾滋病毒治疗。这项研究的结果将影响全世界的护理，因为在所有环境中，很大一部分新诊断出的艾滋病毒患者在开始抗逆转录病毒疗法之前都无法进行随访。