Tuberculosis (TB) remains a major global public health challenge. In 2024, TB caused an estimated 10.7 million new cases and 1.23 million deaths, retaining its position as the leading cause of mortality from a single infectious agent. Although China is now classified as a low-to-middle incidence country (49 cases per 100,000 population), it continues to bear a substantial disease burden. In 2024, China reported 696,000 new TB cases, accounting for 6.5% of the global total and ranking fourth worldwide in terms of total case numbers (1).

Treatment non-adherence profoundly influences TB outcomes (2). Since 2005, the standard of care for TB in China has been Directly Observed Treatment (DOT), a strategy where medication intake is supervised by a healthcare worker or trained observer to enhance adherence (3). Under the National Tuberculosis Control Program (NTP), all registered patients are managed using DOT to ensure compliance, contributing to a 95% treatment success rate for new and relapsed drug-sensitive TB in 2024 (1). However, the implementation of DOT presents significant challenges for patients, exacerbated by factors such as stigma, solitary living, frequent travel, and geographical barriers—the latter being particularly problematic in remote rural areas. A systematic review indicated that only 20% of patients received therapy observed by a health professional, while over 50% self-administered their treatment (4). Applying DOT uniformly to all patients is also inconsistent with the people-centered care approach advocated by the WHO consolidated guidelines (5). However, it should be noted that current Chinese TB patient management guidelines do not formally incorporate DATs as a standard component of patient care.

Accumulating evidence from global and Chinese studies suggests that widely implemented digital adherence technologies (DATs) can effectively address these challenges while demonstrating efficacy comparable to that of DOT. Multicenter randomized controlled trials in Tibet (China) and England have shown that DATs can achieve better treatment adherence than DOT (6, 7). Several studies have confirmed the effectiveness of DATs in improving adherence (3, 8), with some demonstrating non-inferiority to DOT (9, 10). A cluster-randomized trial across four countries found no significant difference in unfavorable outcomes between DAT and control groups (11). Furthermore, research indicates that DATs can substantially reduce treatment costs for both patients and healthcare systems (12, 13).

Despite these promising findings, current research has predominantly focused on the effectiveness, acceptability, and feasibility of DATs, with limited investigation into their real-world uptake rates and determining factors. For instance, one study reported that 35.4% of patients pre-allocated to a DAT group did not use the intervention (11). An observational study from China found that nearly 30% of patients declined DAT, with specific groups such as older adults showing significantly lower acceptance (14). Interestingly, other studies, such as that by Kevin Guzman and colleagues, have reported greater acceptance of electronic adherence tools among older adults compared to younger individuals (15), highlighting the need for context-specific understanding.

Beginning in 2024, Fujian Province initiated a province-wide implementation of digital adherence technology. The adoption of this intervention follows a shared decision-making process between patients and clinicians at designated hospitals. Currently, there is a lack of data on the utilization, effectiveness, and factors influencing the non-adoption of DATs in Fujian Province. This study aims to evaluate the real-world implementation and the effectiveness of DATs in improving treatment adherence. The findings will provide critical evidence to guide the strategic implementation of digital adherence technologies in Fujian and similar settings.

Prior research has established that digital adherence technologies (DATs) can achieve treatment adherence outcomes non-inferior to traditional interventions (9, 10). while demonstrating favorable cost-effectiveness (12, 13). Multiple studies have also reported good acceptability and feasibility of DATs (15, 16). The present study found a relatively low utilization rate of DATs (50.9%), which is lower than rates reported in previous studies (11, 14). This discrepancy may be attributed to the different study contexts: our data were derived from real-world implementation, whereas prior evidence largely came from rigorously designed cluster-randomized trials (9) or national DAT promotion programs (12). In our setting, the adoption of DATs was influenced not only by patient preference but also by the willingness of clinicians or nurses at designated TB hospitals to recommend the technology. According to current Chinese TB patient management guidelines, DATs are not formally recommended as a standard management tool. Primary healthcare workers provide routine care as stipulated, while the decision to use DATs is made through consultation between clinicians/nurses at designated hospitals and patients, after which primary healthcare providers are notified. Some hospital-based staff, burdened by heavy workloads, were reluctant to adopt DATs due to the perceived additional effort required to learn and explain the technology to patients (17). Consistent with this, Li et al. found that healthcare workers play a crucial role in improving patient awareness and willingness to use DATs (18).

On the other hand, as a novel adherence intervention, DATs may also raise concerns among patients. For instance, users of the WeChat-based mHealth component worried about personal data privacy and potential complications from information leakage. Users of the smart pillbox expressed concern that the device or its audible reminders could draw unwanted attention from others, thereby exacerbating disease-related stigma and reducing their willingness to use the technology (18). Moving forward, it is recommended to refine TB patient management protocols by incorporating DATs as an optional management strategy. Enhancing training for healthcare workers to improve their knowledge and willingness to promote DATs is also essential. Finally, adherence interventions should be tailored based on patient preferences to facilitate wider and more effective implementation.

We identified several factors associated with a higher likelihood of adopting DATs for adherence support, including female sex, belonging to an ethnic minority group, being treated with fixed-dose combinations (FDCs), and having concurrent extra-pulmonary tuberculosis. Consistent with our findings, a systematic review and a subsequent Chinese study on TB patients with comorbidities both reported superior treatment adherence among females (19, 20). The greater inclination of ethnic minorities to use DATs compared to the Han majority may be linked to their frequent residence in remote rural areas. For these populations, DATs can reduce the need for in-person visits, saving travel time and costs, and facilitate easier communication with managing physicians (15). Furthermore, some evidence suggests that ethnic minority patients may exhibit greater trust in healthcare providers, potentially contributing to higher adherence (21). Patients prescribed FDCs showed a higher DAT uptake rate. As FDCs are specifically designed to simplify regimens and improve adherence (22), patients opting for this treatment may inherently prioritize adherence and thus be more receptive to supplementary tools like DATs. Similarly, patients with more severe disease presentations, such as those with extra-pulmonary involvement, may demonstrate greater trust in medical advice and adherence motivation in their pursuit of recovery.

Notably, willingness to use DATs was higher in other prefectural cities compared to Fuzhou. This may be explained by the centralized care model in Fuzhou, where most patients are treated at provincial-level TB-designated hospitals. In this model, follow-up management is delegated to primary care institutions based on the patient’s residential address. Provincial hospital physicians, burdened by high patient volumes, are less involved in routine health management and may be less likely to recommend DATs. A similarly low DAT uptake among migrant populations can be attributed to this fragmentation of care, where the treating hospital and the managing health authority are in different regions, reducing the clinician’s incentive to promote DATs. Optimizing the implementation workflow by involving the actual care manager in the shared decision-making process with the patient regarding DAT use could potentially improve adoption rates.

Conversely, the presence of symptoms at diagnosis was associated with a lower tendency to use DATs. This may reflect differing levels of health engagement; patients presenting with symptoms might have lower baseline health awareness, which could correlate with generally poorer medication adherence.

Our study found that, both in the real-world cohort and in the propensity score-matched subgroup balanced for potential confounders, patients in the DAT group achieved a significantly higher sputum smear microscopy completion rate at the end of the second treatment month compared to the routine care group. This endpoint serves as a practical indicator of adherence to the treatment regimen (23). Consistent with previous studies, no significant difference was observed in the month-2 sputum conversion rate among bacteriologically confirmed patients between the DAT and routine care groups (9). This may be attributed to several factors. First, sputum conversion is not solely dependent on adherence but is also influenced by drug sensitivity and individual pharmacokinetic variability (24, 25). Second, the overall conversion rates were high in both groups, and the current sample size may be insufficient to detect a statistically significant but modest incremental effect attributable to DATs. The loss to follow-up rates did not differ significantly between the two groups, a result consistent with existing literature (3, 9, 11). Previous research suggests that DATs may be most effective for patients who are already motivated to adhere, whereas they might not fundamentally alter the behavior of those unwilling to adhere, necessitating additional tailored interventions (3). Consequently, future research should focus on developing and evaluating strategies to improve adherence specifically among patients identified as non-adherent through DAT monitoring, with the ultimate goal of enhancing overall treatment success rates.

In summary, the utilization rate of digital adherence technology (DAT) in Fujian Province remains suboptimal, with uptake influenced by individual factors such as patient sex, place of residence, and presence of extrapulmonary tuberculosis. This study provides an empirical basis for future scale-up of electronic adherence interventions. The use of DAT was associated with improved patient adherence to scheduled sputum smear monitoring; however, it did not significantly impact loss to follow-up or sputum conversion rates at the end of the intensive treatment phase. Moving forward, optimizing patient management protocols and DAT implementation workflows is crucial to enhance accessibility and acceptability. Further research should focus on developing effective interventions for patients identified as non-adherent through DAT monitoring, with the aim of maximizing the impact of DATs on both treatment adherence and clinical outcomes.

Our study has several limitations. First, as a retrospective analysis of real-world data, it may be subject to unobserved confounding factors, which could introduce bias and affect the accuracy of our findings. Second, our analysis did not include factors related to healthcare providers. Future research should incorporate comprehensive surveys involving patients, healthcare workers, and program implementers—key stakeholders in DAT implementation—to better assess the influence of each party on the adoption and effectiveness of digital adherence technologies.