Effect of Digital Adherence Tools on adherence to antiretroviral treatment among adults living with HIV in Kilimanjaro, Tanzania: a randomized controlled trial.

BACKGROUND Lifelong adherence to antiretroviral treatment (ART) remains challenging for people living with HIV (PLHIV). The aim of this study was to investigate whether any of two digital adherence tools (DAT) could improve adherence among PLHIV in Kilimanjaro, Tanzania. METHODS We performed a parallel three-arm non-blinded randomized controlled trial with 1:1:1-allocation. We included adults aged between 18 and 65 years, living in Kilimanjaro Region, and who were on ART for at least six months. Their adherence as judged by the study nurses had to be suboptimal. In one arm, participants received reminder short message service (SMS)-texts followed by a question-SMS. In the second arm, participants received a real-time medication monitoring (RTMM) device (Wisepill®) with SMS-reminders. In the third arm, participants received standard care only. The primary outcome of mean adherence over 48 weeks was compared between arms using between-group t-tests in a modified intention-to-treat analysis. RESULTS In each arm, we randomized 83 participants: data of 82 participants in the RTMM arm, 80 in the SMS-arm and 81 in the standard care arm were analyzed. Mean average (over 48 weeks) adherence in the SMS, RTMM and control arm was 89.6%, 90.6% and 87.9% for pharmacy refill; 95.9%, 95.0% and 95.2% for self-report in the past week; and in the past month 97.5%, 96.6% and 96.9% (p-values not statistically significant). CONCLUSIONS Receiving reminder SMS or RTMM combined with feedback about adherence levels and discussion of strategies to overcome barriers to adherence did not improve adherence to treatment and treatment outcome in PLHIV.