The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania
The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania
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DOI：
10.1186/s12913-017-2032-7
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发表时间：
2017-02-22
影响因子：
2.8
通讯作者：
Barnighausen, Till
中科院分区：
文献类型：
--
作者：
Geldsetzer, Pascal;Francis, Joel M.;Barnighausen, Till
背景：社区卫生工作者（CHWs）在家提供抗逆转录病毒治疗（ART）可以通过减少时间负担和定期前往ART诊所的自付费用来改善ART的保留。此外，抗逆转录病毒疗法家庭分娩可以缩短等待时间，并通过减少抗逆转录病毒疗法诊所的充血来提高那些在设施护理中的人的护理质量。本试验旨在确定在实现和维持病毒学抑制方面，对抗逆转录病毒治疗临床稳定的患者进行抗逆转录病毒治疗家庭分娩与对抗逆转录病毒治疗不稳定的患者进行机构护理是否不逊色于标准护理（对所有抗逆转录病毒治疗患者进行机构护理）。方法：这是一项在坦桑尼亚达累斯萨拉姆进行的非劣效群随机试验。一个集群是48个医疗保健设施之一，其周围的集水区。24组随机分为ART家庭分娩组，24组随机分为标准护理组。干预包括由卫生保健员家访，为接受抗逆转录病毒治疗稳定的患者提供咨询和提供抗逆转录病毒治疗，而控制是标准护理（以设施为基础的抗逆转录病毒治疗和卫生保健员家访，不提供抗逆转录病毒治疗）。此外，每个研究组中有一半的医疗机构在家访期间随机接受标准咨询（包括计划生育、预防艾滋病毒传播和抗逆转录病毒治疗），另一半接受标准加营养咨询（包括食品生产和饮食建议）。非劣效性设计适用于ART家庭分娩试验的终点；主要终点是在研究期结束时，在医疗机构接受抗逆转录病毒治疗的患者病毒受到抑制的比例。该主要终点的非劣效性裕度设定为9个百分点。讨论：随着撒哈拉以南非洲地区抗逆转录病毒治疗患者数量的增加，本试验为家庭护理模式的有效性提供了因果证据，这种模式可以减少抗逆转录病毒治疗诊所的拥挤并减少患者的医疗保健支出。更广泛地说，这项试验将告知越来越多的政策兴趣，慢性病护理从设施到社区卫生保健工作者的任务转移。
Background: Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) may improve ART retention by reducing the time burden and out-of-pocket expenditures to regularly attend an ART clinic. In addition, ART home delivery may shorten waiting times and improve quality of care for those in facility-based care by decongesting ART clinics. This trial aims to determine whether ART home delivery for patients who are clinically stable on ART combined with facility-based care for those who are not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression.Methods: This is a non-inferiority cluster-randomized trial set in Dar es Salaam, Tanzania. A cluster is one of 48 healthcare facilities with its surrounding catchment area. 24 clusters were randomized to ART home delivery and 24 to the standard of care. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART and CHW home visits without ART home delivery). In addition, half of the healthcare facilities in each study arm were randomized to standard counseling during home visits (covering family planning, prevention of HIV transmission, and ART adherence), and half to standard plus nutrition counseling (covering food production and dietary advice). The non-inferiority design applies to the endpoints of the ART home delivery trial; the primary endpoint is the proportion of ART patients at a healthcare facility who are virally suppressed at the end of the study period. The margin of non-inferiority for this primary endpoint was set at nine percentage points.Discussion: As the number of ART patients in sub-Saharan Africa is expected to rise, this trial provides causal evidence on the effectiveness of a home-based care model that could decongest ART clinics and reduce patients' healthcare expenditures. More broadly, this trial will inform the increasing policy interest in task-shifting of chronic disease care from facility-to community-based healthcare workers.