Design of a randomized trial to evaluate the influence of mobile phone reminders on adherence to first line antiretroviral treatment in South India - the HIVIND study protocol
Design of a randomized trial to evaluate the influence of mobile phone reminders on adherence to first line antiretroviral treatment in South India - the HIVIND study protocol
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DOI：
10.1186/1471-2288-10-25
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发表时间：
2010-03-26
影响因子：
4
通讯作者：
Diwan, Vinod K.
中科院分区：
文献类型：
--
作者：
De Costa, Ayesha;Shet, Anita;Diwan, Vinod K.
背景：抗逆转录病毒治疗依从性差一直是与艾滋病毒治疗相关的公共卫生挑战。尽管已经报告了不同的支持遵守的干预措施，但它们在低收入环境中的长期可行性仍然不确定。因此，有必要在这样的环境中探索可持续的背景遵守辅助手段，并使用严格的科学设计对其进行测试。目前移动电话在许多资源受限的环境中无处不在，这使得它成为支持遵守的一种适当的、成本相对较低的手段。在印度，手机具有广泛的用途和接受度，是提高服药依从性的潜在可行工具。本文介绍了一项试验的研究方案，以评估手机提醒对印度南部坚持一线抗逆转录病毒治疗的影响。方法/设计：600名符合国家抗逆转录病毒治疗指南一线治疗的初治患者将在印度南部的两家诊所纳入试验。患者将被随机分为对照组和干预组。对照手臂将接受标准护理；干预手臂将接受标准护理加手机提醒。每个提醒将采取自动电话和图片消息的形式。提醒将在患者选择的时间每周发送一次。患者将被随访24个月或直到达到主要结果，即病毒学失败，以较早者为准。自我报告的遵守情况是次要的结果。分析是通过意向治疗进行的。还将进行干预的成本效益研究。讨论：在资源有限的医疗环境中加强电信技术是世界卫生组织的优先事项。这项试验将评估手机提醒的使用是否会影响印度人对一线抗逆转录病毒药物的坚持。
Background: Poor adherence to antiretroviral treatment has been a public health challenge associated with the treatment of HIV. Although different adherence-supporting interventions have been reported, their long term feasibility in low income settings remains uncertain. Thus, there is a need to explore sustainable contextual adherence aids in such settings, and to test these using rigorous scientific designs. The current ubiquity of mobile phones in many resource-constrained settings, make it a contextually appropriate and relatively low cost means of supporting adherence. In India, mobile phones have wide usage and acceptability and are potentially feasible tools for enhancing adherence to medications. This paper presents the study protocol for a trial, to evaluate the influence of mobile phone reminders on adherence to first-line antiretroviral treatment in South India.Methods/Design: 600 treatment naive patients eligible for first-line treatment as per the national antiretroviral treatment guidelines will be recruited into the trial at two clinics in South India. Patients will be randomized into control and intervention arms. The control arm will receive the standard of care; the intervention arm will receive the standard of care plus mobile phone reminders. Each reminder will take the form of an automated call and a picture message. Reminders will be delivered once a week, at a time chosen by the patient. Patients will be followed up for 24 months or till the primary outcome i.e. virological failure, is reached, whichever is earlier. Self-reported adherence is a secondary outcome. Analysis is by intention-to-treat. A cost-effectiveness study of the intervention will also be carried out.Discussion: Stepping up telecommunications technology in resource-limited healthcare settings is a priority of the World Health Organization. The trial will evaluate if the use of mobile phone reminders can influence adherence to first-line antiretrovirals in an Indian context.