Engagement With Digital Adherence Technologies as Measures of Intervention Fidelity Among Adults With Drug-Susceptible Tuberculosis and Health Care Providers: Descriptive Analysis Using Data From Cluster-Randomized Trials in Five Countries

Abstract

Background: Digital adherence technologies (DATs) are promising tools for supporting tuberculosis (TB) treatment. DATs can serve as reminders for people with TB to take their medication and act as proxies for adherence monitoring. Strong engagement with DATs, from both the person with TB and health care provider (HCP) perspectives, is essential for ensuring intervention fidelity. The Adherence Support Coalition to End TB (ASCENT) project evaluated 2 types of DATs, pillboxes and medication labels (99DOTS), in cluster-randomized trials across 5 countries.

Objective: This study aims to investigate participant and HCP engagement with DATs for TB treatment, stratified by DAT type and country.

Methods: This study is a subanalysis of data generated through the ASCENT trials, which enrolled adults with drug-susceptible TB. A digital dose was defined as either a pillbox opening (for pillbox users) or a dosing confirmation SMS text message sent by the participant (for label users), both of which were recorded on the adherence platform. Descriptive analysis was used to provide an overview of dose-day outcomes. DAT engagement was assessed from both participant and HCP perspectives. To enhance participant engagement, we summarized the frequency of digital engagement overall and by treatment phase, as well as the frequency of consecutive days without engagement. For HCP engagement, we summarized the frequency of doses added manually, the number of days between the actual dose day and when a manual dose was added, and instances of consecutive manual dosing lasting more than 3 and more than 7 days, where doses were added more than 1 week after the dose day.

Results: Of the 9511 participants included, 6719 (70.64%) were using the pillbox, 3544 (37.26%) were female, and the median age was 40 years. Across DAT types, there were 1,384,879 dose days, with 973,876 (70.32%) contributed by pillbox users. Of all dose days, 1,165,195 (84.14%) were recorded as digital, 156,664 (11.31%) as manual, 59,045 (4.26%) had no information, and 3975 (0.29%) were confirmed as missed. Digital dosing decreased slightly from the intensive to the continuation phase. The percentage of digital dose days was higher among pillbox users (851,496/973,876, 87.43%) compared with label users (313,699/411,003, 76.33%). Among label users, manual dosing was most common in the Philippines (37,919/171,786, 22.07%) and least common in Tanzania (11,108/76,231, 14.57%). Among pillbox users, manual dosing was most common in the Philippines (24,015/208,130, 11.54%) and Ukraine (13,209/111,901, 11.80%). Overall, 512 out of 2792 (18.34%) label users and 588 out of 6719 (8.75%) pillbox users experienced a run of more than 7 consecutive nondigital dose days that were resolved more than 1 week after the dose day. The highest occurrence was observed in the Philippines (368/1142, 32.22%, for label users and 224/1351, 16.58%, for pillbox users).

Conclusions: There was considerable variation in DAT engagement across countries and DAT types, reflecting differences in how the intervention was implemented. Further refinement of the intervention and improvements in its delivery may be necessary to enhance outcomes.

Keywords: DAT engagement; digital adherence technology; digital dosing; intervention fidelity; manual dosing; tuberculosis.

Figure 1.. Illustration of 2 scenarios showing suboptimal engagement by person on tuberculosis treatment. Acceptable engagement is defined as ≤3 consecutive days with no digital confirmation. Suboptimal engagement is defined as (1) >3 consecutive dose days or (2) >7 consecutive dose days with no digital confirmation. Scenario 1: The patient had consecutive nondigital confirmation on days 7 to 9 (3 days; inclusive) and days 14 to 15 (2 days; inclusive); the suboptimal engagement condition of either >3 or >7 consecutive dose days is not met. Scenario 2: The patient had consecutive nondigital dose days on days 2 to 10 (9 days; inclusive) and days 13 to 19 (7 days; inclusive); the suboptimal engagement condition of (1) >3 dose days is met twice (on day 5 and day 16) and (2) >7 consecutive dose days is met once (on day 9).

Figure 2.. Illustration of 3 scenarios showing suboptimal engagement by health care professionals (HCPs). Suboptimal engagement is defined as (1) delayed action of manual/confirmed missed dose added by the HCP or no information about a dose and (2) this occurring for periods of consecutive days where non-digital dosing occurred. All scenarios show periods when the patient opened and did not open the pillbox. Scenario 1: HCP added manual/confirmed missed doses on days 10 and 20; of 11 doses added, 10 were within (≤) 7 days of the dose day; dose day 12 was added on day 20 (8 days late); the suboptimal engagement condition is not met. Scenario 2: HCP added manual/confirmed missed doses on day 18; of 10 doses added, 8 doses added were >7 days from the dose day; there is a run of 8 days where doses were added late (dose days 3-10; inclusive); the suboptimal engagement condition is met (consecutive dose days >3 and >7). Scenario 3: HCP added manual/confirmed missed doses on days 13 and 18; of 14 doses added, 4 were >7 days from the dose day; there is a run of 4 days where doses were added late (dose days 2-5; inclusive); the suboptimal engagement condition is met (consecutive dose days >3). *From actual dose day to when the dose was added (either as a manual or confirmed missed dose) by HCP.

Figure 3.. Bar charts showing the distribution of the total number of participant-level episodes (grouped) of consecutive nondigital dose days lasting >3 and >7 days over the 6-month treatment period, stratified by country of enrollment and type of digital adherence technology received. Top panels: summary at the participant level of the number of episodes (grouped into 0, 1, 2, 3, and ≥4 episodes) where >3 consecutive non-digital dose-days were observed for pillbox (left) and labels (right), by country. Lower panels: summary at the participant level of the episodes (grouped into 0, 1, 2, 3, and ≥4 episodes) where >7 consecutive non-digital dose-days were observed for pillbox (left) and labels (right), by country.