Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017)

Abstract

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.

Keywords: Adherence; Computer-assisted self-interview; HIV; PrEP; Short Message Service (SMS) text messaging; mHealth.

Conflict of interest statement

Conflicts of interest

None

Published by Elsevier Inc.

Figures

Figure 1. MTN-017 study design

PERIOD 1 - PERIOD 3 [Pd1-Pd3]: Are the different treatment crossover periods for each of the three regimens. V1 – V10: Are the visits that participants were required to make during each period of their treatment regimens. [19]

Figure 2. The process of data convergence from multiple sources

SMS was used in concert with other data forms to produce the clearest picture possible of participant adherence. SMS: Short message service, PK: pharmacokinetic results, CASI: Computer Assisted Self-Interview. SMS Reports consisted of SMS-CASI data. *Traditional computer-based CASI data was reviewed at the end of study.[19]

Figure 3

The eHealth Behavior Management model

Figure 4

SMS-CASI schema adapted to the eHealth Behavior Management model

Figure 5

SMS-CASI system architecture

Figure 6

Centralized data management with a federated SMS-CASI system schema