Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB)
Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB)
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DOI：
10.1186/s13012-020-00988-y
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发表时间：
2020-04-21
影响因子：
7.2
通讯作者：
Cattamanchi, Adithya
中科院分区：
文献类型：
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作者：
Reza, Tania F.;Nalugwa, Talemwa;Cattamanchi, Adithya
结核病诊断和治疗延误在高负担国家仍然很常见。为了改进病例检测，已投入大量资金扩大Xpert MTB/RIF (Xpert)，这是一种基于药盒的核酸扩增检测，可在2小时内检测出结核病，作为痰涂片镜检的替代品。然而，实现Xpert测试的最佳策略仍然不清楚。方法Xpert结核病治疗联动性绩效评估（XPEL-TB）试验采用超实用的混合II型有效性实施设计来评估在现实环境中提供Xpert测试的简化策略的有效性和实施情况。20家拥有结核病显微镜设备的卫生中心被选中参与试验，其中10家卫生中心被随机分配到干预策略（使用GeneXpert Edge进行现场分子检测，重新设计流程以促进当日结核病诊断和治疗，以及绩效反馈）或常规护理（现场痰涂片显微镜检查，并将痰样本转介到Xpert检测点）。主要结果是微生物学证实的结核病患者在到保健中心就诊后14天内开始接受治疗的人数，这反映了结核病诊断评估过程的成功完成。次要结果包括健康结果（6个月生命状况），以及干预战略的覆盖范围、采用和实施措施。XPEL-TB试验的设计元素和实施方法是有意选择的，以尽量减少对常规护理程序的干扰，目的是限制它们对主要和次要结局的影响。试验结果可能会增加对快速现场分子检测的支持和资助，使其成为所有接受结核病评估的患者的标准治疗方法。
Background Delays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridge-based nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear. Methods The Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy. Discussion The design elements and implementation approach for the XPEL-TB trial were intentionally selected to minimize disruptions to routine care procedures, with the goal of limiting their influence on key primary and secondary outcomes. Trial findings may result in increased support and funding for rapid, onsite molecular testing as the standard-of-care for all patients being evaluated for TB.