Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study.
Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study.
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DOI：
10.1136/bmjopen-2017-017507
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发表时间：
2017-09-27
期刊：
影响因子：
2.9
通讯作者：
Drain PK
中科院分区：
文献类型：
--
作者：
Dorward J;Garrett N;Quame-Amaglo J;Samsunder N;Ngobese H;Ngomane N;Moodley P;Mlisana K;Schaafsma T;Donnell D;Barnabas R;Naidoo K;Abdool Karim S;Celum C;Drain PK
要实现联合国艾滋病毒和艾滋病联合规划署的“90-90-90”目标，需要在不使卫生系统负担过重的情况下扩大抗逆转录病毒治疗覆盖面的艾滋病毒护理模式。即时护理（POC）病毒载量（VL）检测有可能有效监测抗逆转录病毒治疗，而注册护士可能能够为病情稳定的艾滋病毒患者提供安全和具有成本效益的慢性护理。本研究旨在证明与基于实验室的VL监测和标准HIV护理相比，POC VL检测结合任务转移到注册护士是否具有非劣势和成本效益。STREAM（简化HIV治疗和监测）研究是一项开放标签、非劣效性、随机对照实施试验。hiv阳性成人，在抗逆转录病毒治疗开始6个月后临床稳定，将在南非的一个大型城市诊所招募。大约396名参与者将以1:1的比例随机分配，接受POC HIV VL监测和潜在的任务转移给注册护士，而不是实验室VL监测和标准的南非HIV护理。最初的临床随访将在两组中进行2个月，在入组时进行VL测试，6个月和12个月。在6个月时（开始抗逆转录病毒治疗后1年），两组稳定的参与者将有资格获得差异化护理模式，包括在社区药房分散接受抗逆转录病毒治疗。主要结局是在入组后12个月保持护理和病毒学抑制。次要结局包括适当进入分散抗逆转录病毒治疗方案所需的时间、每位病毒学抑制患者的成本以及与标准治疗相比干预措施的成本效益。研究结果将为在艾滋病毒流行资源有限的环境中扩大VL检测和差异化护理提供信息。夸祖鲁-纳塔尔大学生物医学研究伦理委员会（BFC296/16）和华盛顿大学机构审查委员会（STUDY00001466）已经批准了伦理批准。研究结果将在国际会议上发表，并发表在同行评议的学术期刊上。NCT03066128;Pre-results。
Achieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shifting to enrolled nurses is non-inferior and cost-effective compared with laboratory-based VL monitoring and standard HIV care. The STREAM (Simplifying HIV TREAtment and Monitoring) study is an open-label, non-inferiority, randomised controlled implementation trial. HIV-positive adults, clinically stable at 6 months after ART initiation, will be recruited in a large urban clinic in South Africa. Approximately 396 participants will be randomised 1:1 to receive POC HIV VL monitoring and potential task shifting to enrolled nurses, versus laboratory VL monitoring and standard South African HIV care. Initial clinic follow-up will be 2-monthly in both arms, with VL testing at enrolment, 6 months and 12 months. At 6 months (1 year after ART initiation), stable participants in both arms will qualify for a differentiated care model involving decentralised ART pickup at community-based pharmacies. The primary outcome is retention in care and virological suppression at 12 months from enrolment. Secondary outcomes include time to appropriate entry into the decentralised ART delivery programme, costs per virologically suppressed patient and cost-effectiveness of the intervention compared with standard care. Findings will inform the scale up of VL testing and differentiated care in HIV-endemic resource-limited settings. Ethical approval has been granted by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC296/16) and University of Washington Institutional Review Board (STUDY00001466). Results will be presented at international conferences and published in academic peer-reviewed journals. NCT03066128; Pre-results.
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影响因子：
2.8
作者：
Babigumira JB;Castelnuovo B;Lamorde M;Kambugu A;Stergachis A;Easterbrook P;Garrison LP
通讯作者：
Garrison LP
DOI：
10.1111/tmi.12460
发表时间：
2015-04
期刊：
Tropical medicine & international health : TM & IH
影响因子：
--
作者：
Duncombe C;Rosenblum S;Hellmann N;Holmes C;Wilkinson L;Biot M;Bygrave H;Hoos D;Garnett G
通讯作者：
Garnett G
影响因子：
3.7
作者：
Gous N;Scott L;Potgieter J;Ntabeni L;Enslin S;Newman R;Stevens W
通讯作者：
Stevens W
影响因子：
158.5
作者：
Danel, Christine;Moh, Raoul;Anglaret, Xavier
通讯作者：
Anglaret, Xavier
影响因子：
3.3
作者：
Decroo, Tom;Koole, Olivier;Laga, Marie
通讯作者：
Laga, Marie