Digital Adherence Support for Tuberculosis Treatment: A Multicentre Randomized Trial in Kenya

BackgroundImproving tuberculosis (TB) treatment success is critical for improving the health of individuals with TB, reducing transmission, and lowering treatment costs. We conducted a four-arm randomized controlled trial (RCT) to evaluate whether three digital interventions with increasing support improved treatment outcomes compared to the standard of care. MethodsIn this open-label, parallel RCT in Kenya, all TB patients at 902 participating clinics who had at least 2 months of treatment remaining were eligible for inclusion. Individuals were centrally randomized at a ratio of 4:3:12:12 into a control group that received only the standard of care, or one of the following three intervention groups that received the standard of care plus: (1) a daily SMS medication adherence reminder ( SMS); (2) access to a platform that sent a daily request for self-verification of medication adherence and provided disease information, motivational messages, and an adherence game ( platform); and (3) access to a platform with these same features, plus support from a team of trained supporters ( Keheala). The primary outcomes were: the proportion of individuals who experienced an unsuccessful treatment outcome (a composite of: died, failed treatment, or loss to follow-up), and loss to follow-up (LTFU). The secondary outcome was medication non-adherence, measured via unannounced urine isoniazid tests for a random sample of 731 individuals in the control and Keheala groups. ResultsBetween April 13, 2018 and December 20, 2019, 16,753 individuals were randomized, yielding 14,962 in the mITT population: 1,997 in the control, 1,475 in SMS, 6,057 in platform, and 5,433 in Keheala. Absolute risk of unsuccessful outcomes was 12.4% in the control group. It was reduced by 1.9 percentage points in the SMS group (95% C.I.: -0.1-4.0), 1.9 percentage points in the platform group (95% C.I.: 0.3-3.4), and 2.6 percentage points in the Keheala group (95% C.I.: 1.0-4.2); mostly due to reductions in LTFU. Medication non-adherence was 12.4% in the control group. It was reduced by 7.5 percentage points in the Keheala group (95% C.I.: 2.6-12.5). ConclusionsAll digital health interventions improved treatment outcomes. The Keheala intervention also reduced medication non-adherence. The interventions could be considered as a supplement to the standard of care, especially in resource-constrained regions where in-person support is impractical.