Community delivery of antiretroviral drugs: A non-inferiority cluster-randomized pragmatic trial in Dar es Salaam, Tanzania
Community delivery of antiretroviral drugs: A non-inferiority cluster-randomized pragmatic trial in Dar es Salaam, Tanzania
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DOI：
10.1371/journal.pmed.1002659
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发表时间：
2018-09-01
期刊：
影响因子：
15.8
通讯作者：
Baernighausen, Till
中科院分区：
文献类型：
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作者：
Geldsetzer, Pascal;Francis, Joel M.;Baernighausen, Till
背景随着撒哈拉以南非洲地区艾滋病毒感染者的增加以及抗逆转录病毒治疗（ART）资格标准的扩大，人们对使用新型输送模式产生了浓厚的兴趣，这种模式可以使人手不足的卫生系统成功应对抗逆转录病毒药物（ARV）不断增长的需求。这项在坦桑尼亚达累斯萨拉姆进行的务实随机对照试验评估了一种新的抗逆转录病毒社区交付模式：非专业卫生工作者（家庭护理人员 [HBC]）将抗逆转录病毒药物运送到接受 ART 临床稳定的患者家中，而护士和医生为临床不稳定的患者提供标准的基于设施的护理。具体来说，该试验旨在评估抗逆转录病毒社区交付模式在避免病毒学失败方面是否至少与护理标准（针对所有 ART 患者的基于设施的护理）表现同样出色。方法和结果该研究于 2016 年 3 月 1 日至 2017 年 10 月 27 日进行。达累斯萨拉姆提供 ART 并拥有公共部门 HBC 附属团队的所有 (48) 家医疗机构均以 1:1 随机分配至任一组(i) 抗逆转录病毒药物社区提供（干预）或 (ii) 护理标准（控制）。我们预先设定的主要终点是研究期结束时病毒学失败的成人非妊娠 ART 患者的比例。预先指定的非劣效性界限是风险比 (RR) 1.45。平均随访期为 326 天。我们使用对数二项式模型调整医疗机构级别聚类的标准误差来获得意向治疗 (ITT) RR。干预设施（1,163 名患者）和对照设施（1,009 名患者）总共招募了 2,172 名患者。在干预组的 1,163 名患者中，516 名 (44.4%) 的 ART 治疗临床效果稳定，并选择在家中或在社区中选择的另一个会面点接受抗逆转录病毒药物。在研究期结束时，对照组中有 10.9% (95/872) 的患者和干预组中有 9.7% (91/943) 的患者病毒学失败。病毒学失败的 ITT RR 证明了 ARV 社区给药模式的非劣效性（RR 0.89 [单侧 95% CI 0.00 +/- 1.18]）。我们发现，在研究退出前的过去 6 个月内，研究组之间自我报告的患者医疗保健支出没有显着差异。在社区接受抗逆转录病毒治疗的患者中，97.2% (95% CI 94.7% +/- 98.7%) 表示对该计划“满意”或“非常满意”。除了失访（干预组为 18.9%，对照组为 13.6%）外，该试验的主要限制是医疗设施的拥挤状况并未实现，因此使我们预先注册的 ITT 方法（包括干预样本中那些没有资格在家接受 ARV 的人）的逻辑不那么引人注目。结论在这项研究中，ARV 社区交付模型的表现至少与病毒学关键健康指标方面的护理标准一样。失败。该干预措施并未显着减少患者的医疗支出，但对该计划的满意度很高，并且可能会节省患者的时间。政策制定者应考虑试点、评估和扩大更雄心勃勃的抗逆转录病毒社区交付计划，以惠及更高比例的抗逆转录病毒治疗患者。
BackgroundWith the increase in people living with HIV in sub-Saharan Africa and expanding eligibility criteria for antiretroviral therapy (ART), there is intense interest in the use of novel delivery models that allow understaffed health systems to successfully deal with an increasing demand for antiretroviral drugs (ARVs). This pragmatic randomized controlled trial in Dar es Salaam, Tanzania, evaluated a novel model of ARV community delivery: lay health workers (home-based carers [HBCs]) deliver ARVs to the homes of patients who are clinically stable on ART, while nurses and physicians deliver standard facility-based care for patients who are clinically unstable. Specifically, the trial aimed to assess whether the ARV community delivery model performed at least equally well in averting virological failure as the standard of care (facility-based care for all ART patients).Methods and findingsThe study took place from March 1, 2016, to October 27, 2017. All (48) healthcare facilities in Dar es Salaam that provided ART and had an affiliated team of public-sector HBCs were randomized 1: 1 to either (i) ARV community delivery (intervention) or (ii) the standard of care (control). Our prespecified primary endpoint was the proportion of adult non-pregnant ART patients with virological failure at the end of the study period. The prespecified margin of non-inferiority was a risk ratio (RR) of 1.45. The mean follow-up period was 326 days. We obtained intent-to-treat (ITT) RRs using a log-binomial model adjusting standard errors for clustering at the level of the healthcare facility. A total of 2,172 patients were enrolled at intervention (1,163 patients) and control (1,009 patients) facilities. Of the 1,163 patients in the intervention arm, 516 (44.4%) were both clinically stable on ART and opted to receive ARVs in their homes or at another meeting point of their choosing in the community. At the end of the study period, 10.9% (95/872) of patients in the control arm and 9.7% (91/943) in the intervention arm were failing virologically. The ITT RR for virological failure demonstrated non-inferiority of the ARV community delivery model (RR 0.89 [1-sided 95% CI 0.00 +/- 1.18]). We observed no significant difference between study arms in self-reported patient healthcare expenditures over the last 6 months before study exit. Of those who received ARVs in the community, 97.2% (95% CI 94.7% +/- 98.7%) reported being either "satisfied" or "very satisfied" with the program. Other than loss to follow-up (18.9% in the intervention and 13.6% in the control arm), the main limitation of this trial was that substantial decongestion of healthcare facilities was not achieved, thus making the logic for our preregistered ITT approach (which includes those ineligible to receive ARVs at home in the intervention sample) less compelling.ConclusionsIn this study, an ARV community delivery model performed at least as well as the standard of care regarding the critical health indicator of virological failure. The intervention did not significantly reduce patient healthcare expenditures, but satisfaction with the program was high and it is likely to save patients time. Policy-makers should consider piloting, evaluating, and scaling more ambitious ARV community delivery programs that can reach higher proportions of ART patients.