PD04.03
Background: Adherence to product use in a clinical trial is critical to assessing safety and efficacy. Real-time data collection can help monitor adherence. The ubiquity of Short Message Service (SMS) allows researchers to collect adherence data and provide behavioral reminders remotely in real-time. MTN-017 is a phase 2 safety and acceptability study of oral Truvada tablets and rectally-applied tenofovir gel. To monitor adherence in MTN-017, we sought to
1) identify an SMS system that allowed for daily reminders and collection of data on product use,
2) implement it in four countries and five languages, and
3) develop a centralized data management system with an automated backup system.
Methods: We assessed feature availability of several SMS systems based on ideal criteria, including keyword response, email capability, participant identification and grouping, text message scheduling, multiple language operating system, and international SMS capability. After identifying the optimal SMS system, we systematically implemented it in each country, working with IT staff at clinical research sites.
Results: We successfully addressed 24 critical challenges pre- and post-implementation. Solutions included: developing a federated SMS-system architecture to mitigate SMS message costs and manage data access; using secure email protocols to centralize data backup, developing several programming syntaxes to facilitate daily data analysis, developing a calendar template for reporting SMS behavior to sites, ambiguation of text message language to increase privacy, and standardizing operating systems and hardware to minimize variability in system performance. Other solutions and metrics for estimating cost effectiveness will be discussed.
Conclusions: Our tests and continued use have allowed us to identify factors that should be consistent across countries to ensure smooth implementation and operation of SMS as an adherence reminder system and real-time data collection modality.
