VIBRA trial - Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho
VIBRA trial - Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho
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DOI：
10.1186/s13063-019-3510-5
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发表时间：
2019-08-22
期刊：
影响因子：
2.5
通讯作者：
Labhardt, Niklaus Daniel
中科院分区：
文献类型：
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作者：
Amstutz, Alain;Lejone, Thabo Ishmael;Labhardt, Niklaus Daniel
有必要评估以社区为基础的抗逆转录病毒治疗（ART）提供模式，以提高艾滋病毒项目的整体绩效，特别是在可能难以获得持续护理的人群中。这项随机分组临床试验旨在评估在南部非洲莱索托偏远村庄进行家庭当天ART启动后多组分差异化ART提供模式（VIBRA模式）的有效性。方法/设计VIBRA试验（基于村庄的ART再填充）是一项在南部非洲莱索托两个地区进行的随机分组平行组优效性临床试验。集群（即，村庄）被随机分配到VIBRA模式或标准护理。这些群组按地区、村庄规模和村庄获得最近的卫生设施的情况进行分层。在社区艾滋病毒检测活动中确定的符合条件的个人（艾滋病毒阳性、10岁或10岁以上、未接受抗逆转录病毒疗法）可在当天在家中开始接受抗逆转录病毒疗法。干预集群提供了一个有两个特点的差异化抗逆转录病毒疗法交付包：（1）由受过培训和监督的乡村卫生工作者（VHW）进行药物补充和随访，（2）通过短信接收个性化的依从性提醒和病毒载量结果通知。对照组将继续接受标准治疗，即，从诊所收集抗逆转录病毒药物补充剂，没有短信通知。主要终点是入组后12个月的病毒抑制。次要终点包括与护理的联系和参与。此外，还计划进行安全性和成本效益分析以及定性研究。最小目标样本量为262名参与者。统计分析将遵循CONSORT指南。VIBRA试验与另一项试验HOSENG（基于家庭的自我测试）试验相关联，这两项试验都在GET ON（GETing tOwards Ninety）研究项目中。讨论VIBRA试验是第一个评估VHWs在ART开始后立即提供ART的试验。它评估了从检测到病毒抑制的整个艾滋病毒护理级联。由于撒哈拉以南非洲的大多数国家都有像莱索托的VHW计划这样的干部，如果证明有效，这种模式有可能扩大规模。系统影响评估将提供有价值的成本估算，定性研究将建议如何进一步修改模型以优化其影响。
Background There is a need for evaluating community-based antiretroviral therapy (ART) delivery models to improve overall performance of HIV programs, specifically in populations that may have difficulties to access continuous care. This cluster-randomized clinical trial aims to evaluate the effectiveness of a multicomponent differentiated ART delivery model (VIBRA model) after home-based same-day ART initiation in remote villages in Lesotho, southern Africa. Methods/design The VIBRA trial (VIllage-Based Refill of ART) is a cluster-randomized parallel-group superiority clinical trial conducted in two districts in Lesotho, southern Africa. Clusters (i.e., villages) are randomly assigned to either the VIBRA model or standard care. The clusters are stratified by district, village size, and village access to the nearest health facility. Eligible individuals (HIV-positive, aged 10 years or older, and not taking ART) identified during community-based HIV testing campaigns are offered same-day home-based ART initiation. The intervention clusters offer a differentiated ART delivery package with two features: (1) drug refills and follow-ups by trained and supervised village health workers (VHWs) and (2) the option of receiving individually tailored adherence reminders and notifications of viral load results via SMS. The control clusters will continue to receive standard care, i.e., collecting ART refills from a clinic and no SMS notifications. The primary endpoint is viral suppression 12 months after enrolment. Secondary endpoints include linkage to and engagement in care. Furthermore, safety and cost-effectiveness analyses plus qualitative research are planned. The minimum target sample size is 262 participants. The statistical analyses will follow the CONSORT guidelines. The VIBRA trial is linked to another trial, the HOSENG (HOme-based SElf-testiNG) trial, both of which are within the GET ON (GETing tOwards Ninety) research project. Discussion The VIBRA trial is among the first to evaluate the delivery of ART by VHWs immediately after ART initiation. It assesses the entire HIV care cascade from testing to viral suppression. As most countries in sub-Saharan Africa have cadres like the VHW program in Lesotho, this model-if shown to be effective-has the potential to be scaled up. The system impact evaluation will provide valuable cost estimations, and the qualitative research will suggest how the model could be further modified to optimize its impact.