Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial
Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial
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DOI：
10.1016/s2352-3018(16)30090-x
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发表时间：
2016-11-01
期刊：
影响因子：
16.1
通讯作者：
Geng, Elvin
中科院分区：
文献类型：
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作者：
Amanyire, Gideon;Semitala, Fred C.;Geng, Elvin
在非洲，高达30%的临床上符合抗逆转录病毒治疗（ART）条件的HIV感染患者没有及时开始治疗。我们评估的effects的干预针对流行的卫生系统的障碍，ART启动的时间和完整性的治疗initiation.Methods在这个阶梯楔形，非盲，群集随机对照试验，在乌干达西南部的20个诊所被随机分配到组的五个诊所，每6个月的干预由一个计算机化的随机数发生器。这一程序一直持续到所有诊所都从控制（标准护理）过渡到干预措施，其中包括由舆论领袖主导的一线卫生工作者培训和辅导，护理点CD 4细胞计数检测平台，修订后的咨询方法，没有强制性的多次启动前会议，以及向设施反馈其ART启动率及其与其他设施的比较情况。在研究期间，临床上符合ART条件的未接受过治疗的HIV感染成人（年龄≥ 18岁）被纳入研究人群。主要结果是在首次获得ART临床资格后14天开始ART治疗。在2013年4月11日至2015年2月2日期间，12024名符合条件的患者访问了20家参与诊所之一。中位CD 4计数为310个细胞/μ L（IQR 179-424）。干预组4747例患者中有3753例（加权比例80%）在合格后2周开始ART，而对照组7066例患者中有2585例（38%）（风险差异41.9%，95% CI 40.1-43 u 8）。随机抽取干预组208名患者和对照组199名患者，确定其生命状态。四例死亡（2%）发生在干预组和五（3%）发生在control group.Interpretation一个多成分的干预措施，针对卫生保健工作者的行为增加的概率ART启动后14天的资格。这种干预措施包括广泛使用的组件，并已在现实世界中进行了测试，因此可以大规模使用。资助国家过敏和传染病研究所（NIAID）和总统艾滋病紧急救援基金（PEPFAR）。
Background In Africa, up to 30% of HIV-infected patients who are clinically eligible for antiretroviral therapy (ART) do not start timely treatment. We assessed the eff ects of an intervention targeting prevalent health systems barriers to ART initiation on timing and completeness of treatment initiation.Methods In this stepped-wedge, non-blinded, cluster-randomised controlled trial, 20 clinics in southwestern Uganda were randomly assigned in groups of fi ve clinics every 6 months to the intervention by a computerised random number generator. This procedure continued until all clinics had crossed over from control (standard of care) to the intervention, which consisted of opinion-leader-led training and coaching of front-line health workers, a point-of-care CD4 cell count testing platform, a revised counselling approach without mandatory multiple pre-initiation sessions, and feedback to the facilities on their ART initiation rates and how they compared with other facilities. Treatmentnaive, HIV-infected adults (aged >= 18 years) who were clinically eligible for ART during the study period were included in the study population. The primary outcome was ART initiation 14 days after fi rst clinical eligibility for ART. This study is registered with ClinicalTrials. gov, number NCT01810289.Findings Between April 11, 2013, and Feb 2, 2015, 12 024 eligible patients visited one of the 20 participating clinics. Median CD4 count was 310 cells per mu L (IQR 179-424). 3753 of 4747 patients (weighted proportion 80%) in the intervention group had started ART by 2 weeks after eligibility compared with 2585 of 7066 patients (38%) in the control group (risk difference 41.9%, 95% CI 40.1-43 u 8). Vital status was ascertained in a random sample of 208 patients in the intervention group and 199 patients in the control group. Four deaths (2%) occurred in the intervention group and fi ve (3%) occurred in the control group.Interpretation A multicomponent intervention targeting health-care worker behaviour increased the probability of ART initiation 14 days after eligibility. This intervention consists of widely accessible components and has been tested in a real-world setting, and is therefore well positioned for use at scale.Funding National Institute of Allergy and Infectious Diseases (NIAID) and the President's Emergency Fund for AIDS Relief (PEPFAR).