Effectiveness of Video Directly Observed Treatment (DOT Selfie), a Mobile Health Intervention to Increase Treatment Adherence Monitoring and Support for Patients with Tuberculosis in Uganda: A Randomized Controlled Trial (Preprint)

BACKGROUND Directly observed therapy (DOT) is the standard for monitoring adherence for tuberculosis (TB) treatment. However, the implementation of DOT is difficult for patients and providers due to a lack of financial and human resources. Mounting evidence suggests that video directly observed therapy (VDOT), an emerging digital adherence technology works but its effectiveness has barely been evaluated in low-income settings where the burden of TB is greatest. OBJECTIVE The study evaluated the effectiveness of Video directly observed treatment for adherence monitoring and support compared to usual care among patients with TB. METHODS Between July, 2020 and October 2021, we conducted a two-arm parallel group, open-label randomized trial with 1:1 assignment to receive the VDOT intervention (n=72) or usual care DOT (UCDOT) (n=72) for treatment adherence monitoring at public health clinics in Kampala, Uganda. Each group was further stratified to have equal numbers of males and females. Eligible patients were 18-65 years old with a confirmed diagnosis of TB and on daily treatment. The VDOT group received a smartphone with an app while the UCDOT group used the routine practice for monitoring treatment per the Uganda National TB program. We tested the hypothesis that VDOT was more effective for monitoring medication adherence compared to UCDOT. The primary outcome was adherence defined as having >=80% of the expected doses observed during the treatment period of 6 months. Intention-to-treat (ITT) analysis was done, and we performed multivariable logistic regression to estimate the effect of the intervention on adherence monitoring. We present adjusted relative risk ratios and the associated 95% confidence intervals. Secondary outcomes were treatment completion, loss to follow-up, death and reasons for missed videos in the intervention group. RESULTS The intention-to-treat analysis included 142 participants. Two participants were excluded due to failure to continue their medication within the first week after enrollment. The median age was 34 years (IQR:26-45). The mean fraction of expected doses observed (FEDO) was significantly higher for the VDOT than the UCDOT group (90% mean FEDO vs 30% mean FEDO, p =80% as optimal adherence, 63 (44.4%) patients achieved the set threshold with a significant difference between VDOT and UCDOT (78.9% vs. 9.9%, p==80% of their expected doses observed compared to UCDOT (Adjusted RR. 8.4, 95% CI 4.16- 17.0). The commonest reasons for failure to submit videos of medication intake were an uncharged phone battery, forgetting to record videos during medication intake, and losing a smartphone. CONCLUSIONS VDOT was more effective for increasing observation of adherence to treatment than UCDOT among patients with TB in Uganda. This evidence supports the promise of digital technologies for improving monitoring and support of treatment adherence in high TB burden settings where human resources are limited. CLINICALTRIAL The clinical trial was registered with ClinicalTrials.gov (NCT04134689).