Forman Leah S, Patts Gregory J, Coleman Sharon M, Blokhina Elena, Lu John, Yaroslavtseva Tatiana, Gnatienko Natalia, Krupitsky Evgeny, Samet Jeffrey H, Chaisson Christine E
1 Data Coordinating Center, School of Public Health, Boston University, Boston, MA, USA.
2 Laboratory of Clinical Pharmacology of Addictions, Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia.
Clin Trials. 2018 Feb;15(1):36-43. doi: 10.1177/1740774517726067. Epub 2017 Aug 10.
BACKGROUND/AIMS: Reproducible outcomes in clinical trials depend on adherence to study protocol. Short message service (also known as text message) reminders have been shown to improve clinical trial adherence in the United States and elsewhere. However, due to systematic differences in mobile data plans, languages, and technology, these systems are not easily translated to international settings.
To gauge technical capabilities for international projects, we developed SMSMessenger, an automated Android application that uses a US server to send medication reminders to participants in a clinical trial in St. Petersburg, Russia (Zinc for HIV disease among alcohol users-a randomized controlled trial in the Russia Alcohol Research Collaboration on HIV/AIDS cohort). The application is downloaded once onto an Android study phone. When it is time for the text message reminders to be sent, study personnel access the application on a local phone, which in turn accesses the existing clinical trial database hosted on a US web server. The application retrieves a list of participants with the following information: phone number, whether a message should be received at that time, and the appropriate text of the message. The application is capable of storing multiple outgoing messages. With a few clicks, text messages are sent to study participants who can reply directly to the message. Study staff can check the local phone for incoming messages. The SMSMessenger application uses an existing clinical trial database and is able to receive real-time updates. All communications between the application and server are encrypted, and phone numbers are stored in a secure database behind a firewall. No sensitive data are stored on the phone, as outgoing messages are sent through the application and not by messaging features on the phone itself. Messages are sent simultaneously to study participants, which reduces the burden on local study staff. Costs and setup are minimal. The only local requirements are an Android phone and data plan.
The SMSMessenger technology could be modified to be applied anywhere in the world, in any language, script, or alphabet, and for many different purposes. The novel application of this existing low-cost technology can improve the usefulness of text messaging in advancing the goals of international clinical trials.
背景/目的：临床试验中可重复的结果取决于对研究方案的依从性。在美国及其他地区，短信服务（也称为文本消息）提醒已被证明可提高临床试验的依从性。然而，由于移动数据套餐、语言和技术方面的系统差异，这些系统不易应用于国际环境。
为评估国际项目的技术能力，我们开发了SMSMessenger，这是一款自动化安卓应用程序，它使用美国服务器向俄罗斯圣彼得堡一项临床试验的参与者发送用药提醒（酒精使用者中锌对HIV疾病的影响——俄罗斯酒精与HIV/AIDS队列研究合作中的一项随机对照试验）。该应用程序只需下载一次到安卓研究手机上。当需要发送短信提醒时，研究人员在本地手机上访问该应用程序，该应用程序进而访问托管在美国网络服务器上的现有临床试验数据库。该应用程序检索包含以下信息的参与者列表：电话号码、当时是否应接收消息以及相应的消息文本。该应用程序能够存储多条外发消息。只需点击几下，短信就会发送给研究参与者，参与者可以直接回复消息。研究人员可以在本地手机上查看收到的消息。SMSMessenger应用程序使用现有的临床试验数据库，并能够接收实时更新。应用程序与服务器之间的所有通信均经过加密，电话号码存储在防火墙后的安全数据库中。手机上不存储任何敏感数据，因为外发消息是通过应用程序发送的，而不是通过手机本身的短信功能。消息会同时发送给研究参与者，这减轻了当地研究人员的负担。成本和设置极少。唯一的本地要求是一部安卓手机和数据套餐。
SMSMessenger技术可以进行修改，以应用于世界任何地方，使用任何语言、文字或字母，用于许多不同目的。这种现有低成本技术的新颖应用可以提高短信在推进国际临床试验目标方面的效用。
