实施基于短信的调查 CASI 和依从性提醒在一项国际生物医学 HIV PrEP 研究（MTN 017）中面临的挑战和解决方案。
Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017).
机构信息
University of California San Francisco, Department of Medicine, Center for AIDS Prevention Studies, San Francisco, CA, USA; Zuckerberg San Francisco General Hospital, UCSF Center for Vulnerable Populations, Health Communications Research Program, San Francisco, CA, USA; New York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, USA.
New York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, USA.
出版信息
J Biomed Inform. 2018 Apr;80:78-86. doi: 10.1016/j.jbi.2018.02.018. Epub 2018 Mar 6.
BACKGROUND
We implemented a text message-based Short Message Service computer-assisted self-interviewing (SMS-CASI) system to aid adherence and monitor behavior in MTN-017, a phase 2 safety and acceptability study of rectally-applied reduced-glycerin 1% tenofovir gel compared to oral emtricitabine/tenofovir disoproxil fumarate tablets. We sought to implement SMS-based daily reminders and product use reporting, in four countries and five languages, and centralize data management/automated-backup.
METHODS
We assessed features of five SMS programs against study criteria. After identifying the optimal program, we systematically implemented it in South Africa, Thailand, Peru, and the United States. The system consisted of four windows-based computers, a GSM dongle and sim card to send SMS. The SMS-CASI was, designed for 160 character SMS. Reminders and reporting sessions were initiated by date/time triggered messages. System, questions, responses, and instructions were triggered by predetermined key words.
RESULTS
There were 142,177 total messages: sent 86,349 (60.73%), received 55,573 (39.09%), failed 255 (0.18%). 6153 (4.33%) of the message were errors generated from either our SMS-CASI system or by participants. Implementation challenges included: high message costs; poor data access; slow data cleaning and analysis; difficulty reporting information to sites; a need for better participant privacy and data security; and mitigating variability in system performance across sites. We mitigated message costs and poor data access by federating the SMS-CASI system, and used secure email protocols to centralize data backup. We developed programming syntaxes to facilitate daily data cleaning and analysis, and a calendar template for reporting SMS behavior. Lastly, we ambiguated text message language to increase privacy, and standardized hardware and software across sites, minimizing operational variability.
CONCLUSION
We identified factors that aid international implementation and operation of SMS-CASI for real-time adherence monitoring. The challenges and solutions we present can aid other researchers to develop and manage an international multilingual SMS-based adherence reminder and CASI system.
背景
我们实施了基于短信的短消息服务计算机辅助自我访谈（SMS-CASI）系统，以帮助 MTN-017 研究的依从性并监测行为，该研究是一项 2 期安全性和可接受性研究，比较了直肠应用低浓度甘油 1%替诺福韦凝胶与口服恩曲他滨/替诺福韦酯片剂。我们试图在四个国家和五种语言中实施基于短信的每日提醒和产品使用报告，并集中数据管理/自动备份。
方法
我们根据研究标准评估了五个 SMS 程序的功能。在确定了最佳程序后，我们在南非、泰国、秘鲁和美国系统地实施了该程序。该系统由四台基于 Windows 的计算机、一个 GSM 数据卡和 SIM 卡组成，用于发送短信。SMS-CASI 专为 160 个字符的短信设计。提醒和报告会话由日期/时间触发的消息启动。系统问题、回复和指令由预定的关键字触发。
结果
共发送了 142177 条短信：发送 86349 条（60.73%），接收 55573 条（39.09%），失败 255 条（0.18%）。6153 条（4.33%）的消息是由于我们的 SMS-CASI 系统或参与者生成的错误。实施过程中的挑战包括：高消息成本；数据访问不佳；数据清理和分析速度缓慢；向站点报告信息困难；需要更好地保护参与者隐私和数据安全；以及减轻站点之间系统性能的差异。我们通过联邦化 SMS-CASI 系统来减轻消息成本和数据访问的问题，并使用安全电子邮件协议来集中备份数据。我们开发了编程语法来促进日常数据清理和分析，并为报告短信行为开发了日历模板。最后，我们模糊了短信语言以提高隐私性，并在站点之间标准化了硬件和软件，最大限度地减少了操作的可变性。
结论
我们确定了有助于实时依从性监测的国际 SMS-CASI 实施和运营的因素。我们提出的挑战和解决方案可以帮助其他研究人员开发和管理国际多语言基于短信的依从性提醒和 CASI 系统。
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