Outcomes of community-based differentiated models of multi-month dispensing of antiretroviral medication among stable HIV-infected patients in Lesotho: a cluster randomised non-inferiority trial protocol
Outcomes of community-based differentiated models of multi-month dispensing of antiretroviral medication among stable HIV-infected patients in Lesotho: a cluster randomised non-inferiority trial protocol
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DOI：
10.1186/s12889-018-5961-0
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发表时间：
2018-08-29
影响因子：
4.5
通讯作者：
Pisa, P. T.
中科院分区：
文献类型：
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作者：
Faturiyele, I. O.;Appolinare, T.;Pisa, P. T.
背景：目前世界卫生组织（世卫组织）指南建议艾滋病毒阳性患者早期开始抗逆转录病毒治疗（ART），无论其临床或免疫状况如何，即所谓的检测和开始方法。与许多其他国家一样，莱索托在2016年引入了这种方法，作为实现流行病控制的一项战略。开始治疗的艾滋病毒感染者人数将迅速增加，这将给卫生系统带来实际挑战，如拥堵、患者等待时间过长以及向患者提供优质服务的时间有限。提供抗逆转录病毒治疗的差异化模式是一种创新解决方案，有助于增加获得保健的机会，同时减轻现有卫生系统的负担。最终，这种模式将有助于实现留存率和病毒抑制。我们描述了一项示范研究，旨在评估莱索托稳定的艾滋病毒患者中基于社区的多月分配（MMD）抗逆转录病毒治疗方法的差异化模型。方法：该研究将是一项三组随机分组试验，将在30个选定的分组中招募约5760名接受抗逆转录病毒治疗稳定的hiv感染者。这些保健设施集群将被随机分配到以下不同的护理组模式中：(i)设施每月提供3次抗逆转录病毒治疗（对照）；（ii）通过社区抗逆转录病毒治疗小组每月提供3次抗逆转录病毒治疗；（iii）通过社区抗逆转录病毒治疗分发点每月提供6次抗逆转录病毒治疗。主要结局是保留护理和病毒学抑制，次要结局包括可行性和成本效益。讨论：将吸取重要经验教训，以便改进此类示范项目的实施，包括对可靠药物供应的各种需求、获得高质量临床数据（包括获得病毒载量（VLs）结果）、支持基层工作人员骨干的框架、社区利益攸关方的参与以及可靠的数据系统（包括关键指标的记录）。烟雾病将有积极的影响，包括改善滞留，病毒学抑制，方便和获得药物。
Background: Current World Health Organization (WHO) guidelines recommend early initiation of HIV positive patients on antiretroviral therapy (ART) irrespective of their clinical or immunological status known as the test and start approach. Lesotho, like many other countries introduced this approach in 2016 as a strategy to reach epidemic control. There will be rapidly growing number of HIV-infected individuals initiating treatment leading to practical challenges on health systems such as congestion, long waiting time for patients and limited time to provide quality services to patients. Differentiated models of ART delivery is an innovative solution that helps to increase access to care, while reducing the burden on existing health systems. Ultimately this model will help to achieve retention and viral suppression. We describe a demonstration study designed to evaluate a community-based differentiated model of multi-month dispensing (MMD) approaches of ART among stable HIV patients in Lesotho.Methods: This study will be a three-arm cluster randomised trial, which will enrol approximately 5760 HIV-infected individuals who are stable on ART in 30 selected clusters. The clusters, which are health facilities, will be randomly assigned into the following differentiated model of care arms: (i) 3 monthly ART supply at facilities (Control), (ii) 3 monthly ART supply through community ART groups (CAGs) and (iii) 6 monthly ART supply through community ART distribution points (CAD). Primary outcomes are retention in care and virologic suppression, and secondary outcomes include feasibility and cost effectiveness.Discussion: Important lessons will be learnt to allow for improved implementation of such demonstration projects, including various needs for reliable supply of medication, access to quality clinical data including access to viral loads (VLs) results, frameworks to support lay worker cadre, involvement of community stakeholders, and reliable data systems including records of key indicators. MMD will have positive implications including improved retention, virologic suppression, convenience and access to medication.