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肯尼亚移动电话短信服务对艾滋病病毒治疗依从性的影响(WelTel Kenya1):一项随机试验。

Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial.

机构信息

Department of Medical Microbiology, University of Nairobi, Nairobi, Kenya.

出版信息

Lancet. 2010 Nov 27;376(9755):1838-45. doi: 10.1016/S0140-6736(10)61997-6. Epub 2010 Nov 9.

Abstract

BACKGROUND

Mobile (cell) phone communication has been suggested as a method to improve delivery of health services. However, data on the effects of mobile health technology on patient outcomes in resource-limited settings are limited. We aimed to assess whether mobile phone communication between health-care workers and patients starting antiretroviral therapy in Kenya improved drug adherence and suppression of plasma HIV-1 RNA load.

METHODS

WelTel Kenya1 was a multisite randomised clinical trial of HIV-infected adults initiating antiretroviral therapy (ART) in three clinics in Kenya. Patients were randomised (1:1) by simple randomisation with a random number generating program to a mobile phone short message service (SMS) intervention or standard care. Patients in the intervention group received weekly SMS messages from a clinic nurse and were required to respond within 48 h. Randomisation, laboratory assays, and analyses were done by investigators masked to treatment allocation; however, study participants and clinic staff were not masked to treatment. Primary outcomes were self-reported ART adherence (>95% of prescribed doses in the past 30 days at both 6 and 12 month follow-up visits) and plasma HIV-1 viral RNA load suppression (<400 copies per mL) at 12 months. The primary analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00830622.

FINDINGS

Between May, 2007, and October, 2008, we randomly assigned 538 participants to the SMS intervention (n=273) or to standard care (n=265). Adherence to ART was reported in 168 of 273 patients receiving the SMS intervention compared with 132 of 265 in the control group (relative risk [RR] for non-adherence 0·81, 95% CI 0·69-0·94; p=0·006). Suppressed viral loads were reported in 156 of 273 patients in the SMS group and 128 of 265 in the control group, (RR for virologic failure 0·84, 95% CI 0·71-0·99; p=0·04). The number needed to treat (NNT) to achieve greater than 95% adherence was nine (95% CI 5·0-29·5) and the NNT to achieve viral load suppression was 11 (5·8-227·3).

INTERPRETATION

Patients who received SMS support had significantly improved ART adherence and rates of viral suppression compared with the control individuals. Mobile phones might be effective tools to improve patient outcome in resource-limited settings.

FUNDING

US President's Emergency Plan for AIDS Relief.

摘要

背景

移动(手机)通讯已被提议作为改善卫生服务提供的一种方法。然而,在资源有限的环境中,关于移动医疗技术对患者结局影响的数据有限。我们旨在评估在肯尼亚开始抗逆转录病毒治疗的卫生保健工作者与患者之间通过手机进行沟通是否能提高药物依从性和抑制血浆 HIV-1 RNA 载量。

方法

WelTel Kenya1 是在肯尼亚三个诊所中对感染 HIV 的成年人开始抗逆转录病毒治疗(ART)的一项多地点随机临床试验。患者通过简单随机化和随机数生成程序按 1:1 比例随机分配到短信服务(SMS)干预组或标准护理组。干预组的患者每周会收到诊所护士发送的 SMS 消息,并要求在 48 小时内回复。随机化、实验室检测和分析均由对治疗分配设盲的研究人员进行;然而,研究参与者和诊所工作人员对治疗不知情。主要结局是自我报告的 ART 依从性(在过去 30 天内,6 个月和 12 个月随访时分别超过处方剂量的 95%)和 12 个月时血浆 HIV-1 病毒 RNA 载量抑制(<400 拷贝/毫升)。主要分析是按意向治疗进行的。该试验在 ClinicalTrials.gov 注册,NCT00830622。

结果

2007 年 5 月至 2008 年 10 月期间,我们将 538 名参与者随机分配至 SMS 干预组(n=273)或标准护理组(n=265)。SMS 干预组有 168 名患者报告了对 ART 的依从性,而对照组有 132 名患者(未依从的相对风险 [RR]为 0.81,95%CI 0.69-0.94;p=0.006)。SMS 组中有 156 名患者报告了病毒载量抑制,对照组中有 128 名患者报告了病毒载量抑制(病毒学失败的 RR 为 0.84,95%CI 0.71-0.99;p=0.04)。达到>95%依从性的治疗需要人数(NNT)为 9(95%CI 5.0-29.5),达到病毒载量抑制的 NNT 为 11(5.8-227.3)。

结论

与对照组相比,接受 SMS 支持的患者的 ART 依从性和病毒抑制率显著提高。手机可能是改善资源有限环境中患者结局的有效工具。

资助

美国总统艾滋病紧急救援计划。

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