Test and Treat TB: A Proof of Concept Trial in South Africa

测试和治疗结核病:南非的概念验证试验

基本信息

  • 批准号:
    8887097
  • 负责人:
  • 金额:
    $ 14.16万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2014
  • 资助国家:
    美国
  • 起止时间:
    2014-07-04 至 2017-06-30
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): The dual epidemics of HIV and TB continue unabated in many urban areas in resource-limited settings, with TB the leading cause of death among patients enrolled in antiretroviral therapy programs in South Africa. Despite substantial investment in healthcare facility-based diagnosis and treatment of TB, only a fraction of HIV-infected people in South Africa are screened for TB and complete TB treatment; therefore TB control at the community level remains poor. Efforts are urgently needed to implement and evaluate strategies that integrate early HIV and TB diagnosis, TB treatment initiation and retention in care, and to consider such strategies in the context of constrained healthcare resources. Xpert MTB/RIF, a novel, rapid, automated molecular diagnostic tool, currently deployed within centralized provincial hospitals in South Africa, has great potential for intensifid case finding at the community level among people who are not currently accessing hospital-based services. This proposal builds upon a successful mobile HIV screening unit that travels to community venues such as taxi stands and malls in the townships of Durban, South Africa. We will leverage this unique program to formally evaluate the value of using Xpert on the mobile unit, and build upon that strategy by implementing and evaluating a "Test & Treat TB" (T&T TB) intervention for promoting linkage to and retention in TB care. T&T TB is a package of interventions that includes: i) Xpert screening with rapid receipt of Xpert MTB/RIF test results at the mobile unit; ii) expedited TB treatment initiation with a "starter pack" at the mobile unit; an iii) monthly SMS (text message) appointment reminders. In a 3-arm design, we will compare: 1) T&T TB; 2) Expedited testing (Xpert screening on the mobile unit with clinic-based follow-up) or 3) Usual care (referral to clinic for TB screening). We propose a proof-of-concept randomized trial to accomplish two specific aims. The first aim is to establish the feasibility, yield, and clnical impact of a "Test & Treat TB" strategy on a mobile HIV screening unit in South Africa. The second aim is to assess the cost and cost-effectiveness of this integrated HIV/TB screening strategy for maximizing linkage to TB care and treatment completion. We hypothesize that the T&T TB strategy will improve rates of TB treatment completion and will be very cost-effective. The cost-effectiveness analysis offers the flexibility to examine the feasibility and affordabilityof Xpert in settings with different HIV and TB prevalences. This proposal is motivated by the 2013 Trans-NIH HIV research plan to investigate new approaches to HIV/TB integration that promote early detection and effective engagement in care, and to assess the effects of these interventions on survival, quality of care, and cost-effectiveness. This novel, mobile, rapid HIV and TB screening intervention will bring Xpert MTB/RIF technology to the "point of care", at the community level, and will use innovative techniques to improve rates of TB treatment completion. This work will inform physicians, governments, and policy makers on how to maximize the benefits of community screening through timely and integrated mobile HIV/TB diagnosis and linkage to care.
描述(由申请人提供):在资源有限的许多城市地区,艾滋病毒和结核病的双重流行仍然有增无减,结核病是南非参加抗逆转录病毒治疗项目的患者的主要原因。尽管对基于医疗机构的结核病诊断和治疗进行了大量投资,但南非只有一小部分艾滋病毒感染者接受了结核病筛查并完成了结核病治疗;因此,社区一级的结核病控制仍然很差。迫切需要努力实施和评估将早期艾滋病毒和结核病诊断、结核病治疗开始和保留护理结合起来的策略,并在医疗资源有限的情况下考虑这些策略。 Xpert MTB/RIF 是一种新型、快速、自动化的分子诊断工具,目前部署在南非的集中省级医院内,对于在社区层面针对目前无法获得医院服务的人群进行强化病例发现具有巨大潜力。该提案建立在一个成功的移动艾滋病毒筛查装置的基础上,该装置可以前往南非德班城镇的出租车站和购物中心等社区场所。我们将利用这一独特的计划来正式评估在移动设备上使用 Xpert 的价值,并通过实施和评估“测试和治疗结核病”(T&T TB) 干预措施来建立该战略,以促进结核病护理的联系和保留。 T&T TB 是一揽子干预措施,包括: i) Xpert 筛查,可在以下地址快速收到 Xpert MTB/RIF 测试结果: 移动装置; ii) 通过移动设备上的“启动包”快速启动结核病治疗; iii) 每月短信(短信)预约提醒。在 3 臂设计中,我们将比较: 1) T&T TB; 2) 快速检测(在移动设备上进行 Xpert 筛查,并进行基于诊所的随访)或 3) 常规护理(转诊至诊所进行结核病筛查)。我们提出了一项概念验证随机试验来实现两个特定目标。第一个目标是确定南非移动艾滋病毒筛查单位“检测和治疗结核病”策略的可行性、产量和临床影响。第二个目标是评估这种综合艾滋病毒/结核病筛查策略的成本和成本效益,以最大限度地提高与结核病护理和治疗完成的联系。我们假设 T&T 结核病策略将提高结核病治疗完成率,并且非常具有成本效益。成本效益分析提供了灵活性,可以检验 Xpert 在不同艾滋病毒和结核病患病率的环境中的可行性和可负担性。该提案受到 2013 年跨 NIH HIV 研究计划的推动,该计划旨在调查 HIV/TB 整合的新方法,以促进早期检测和有效参与护理,并评估这些干预措施对生存、护理质量和成本的影响。效力。这种新颖、移动、快速的 HIV 和结核病筛查干预措施将把 Xpert MTB/RIF 技术引入社区层面的“护理点”,并将使用创新技术来提高结核病治疗完成率。这项工作将告知医生、政府和政策制定者如何通过及时、综合的移动艾滋病毒/结核病诊断和与护理的联系来最大限度地发挥社区筛查的好处。

项目成果

期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Ingrid Valerie Bassett其他文献

Ingrid Valerie Bassett的其他文献

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{{ truncateString('Ingrid Valerie Bassett', 18)}}的其他基金

Mentoring in patient-oriented research on HIV and global health
指导以患者为中心的艾滋病毒和全球健康研究
  • 批准号:
    9889026
  • 财政年份:
    2019
  • 资助金额:
    $ 14.16万
  • 项目类别:
Mentoring in patient-oriented research on HIV and global health
指导以患者为中心的艾滋病毒和全球健康研究
  • 批准号:
    9790038
  • 财政年份:
    2019
  • 资助金额:
    $ 14.16万
  • 项目类别:
Mentoring in patient-oriented research on HIV and global health
指导以患者为中心的艾滋病毒和全球健康研究
  • 批准号:
    10338169
  • 财政年份:
    2019
  • 资助金额:
    $ 14.16万
  • 项目类别:
Mentoring in patient-oriented research on HIV and global health
指导以患者为中心的艾滋病毒和全球健康研究
  • 批准号:
    10570265
  • 财政年份:
    2019
  • 资助金额:
    $ 14.16万
  • 项目类别:
South Africa's new Central Chronic Medicine Dispensing and Distribution program: assessing the clinic, patient, and community impact
南非新的中央慢性药物配发和分配计划:评估诊所、患者和社区的影响
  • 批准号:
    10194606
  • 财政年份:
    2018
  • 资助金额:
    $ 14.16万
  • 项目类别:
South Africa's new Central Chronic Medicine Dispensing and Distribution program: assessing the clinic, patient, and community impact
南非新的中央慢性药物配发和分配计划:评估诊所、患者和社区的影响
  • 批准号:
    10413904
  • 财政年份:
    2018
  • 资助金额:
    $ 14.16万
  • 项目类别:
South Africa's new Central Chronic Medicine Dispensing and Distribution program: assessing the clinic, patient, and community impact
南非新的中央慢性药物配发和分配计划:评估诊所、患者和社区的影响
  • 批准号:
    9751392
  • 财政年份:
    2018
  • 资助金额:
    $ 14.16万
  • 项目类别:
What happens after diagnosis: Characterizing long-term HIV care trajectories and mortality in South Africa
诊断后会发生什么:描述南非长期艾滋病毒护理轨迹和死亡率
  • 批准号:
    9140315
  • 财政年份:
    2016
  • 资助金额:
    $ 14.16万
  • 项目类别:
Test and Treat TB: A Proof of Concept Trial in South Africa
测试和治疗结核病:南非的概念验证试验
  • 批准号:
    8739080
  • 财政年份:
    2014
  • 资助金额:
    $ 14.16万
  • 项目类别:
Linkage & Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa
连锁
  • 批准号:
    7838990
  • 财政年份:
    2010
  • 资助金额:
    $ 14.16万
  • 项目类别:

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利用药物流行病学了解西非艾滋病毒感染者低水平病毒血症的预测因子和影响
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