Tuberculosis (TB) remains a major global public health challenge, particularly in low- and middle-income countries, with an estimated 10.9 million new cases reported worldwide (W.H.O., 2024). Despite ongoing implementation of the End TB Strategy, TB incidence and mortality in Indonesia have increased by 19% and 26%, respectively, since 2015, indicating persistent gaps in disease control (W.H.O., 2024). Poor adherence to long-term anti-tuberculosis therapy remains a key driver of treatment failure, relapse, and the emergence of multidrug-resistant tuberculosis (MDR-TB), which is more difficult and costly to manage ((Espinosa-Pereiro et al., 2022); (Rosu et al., 2023)). Conventional adherence strategies such as Directly Observed Treatment, Short-course (DOTS) are widely implemented but face practical limitations including resource constraints, transportation barriers, and low patient motivation (Mundakir et al., 2021)(Xian et al., 2021). Digital health technologies have therefore been increasingly recommended as alternative approaches to support adherence, including short message services, mobile applications, video-observed therapy, and electronic medication monitoring systems (W.H.O., 2023). Recent studies in Southeast Asia demonstrated that digital interventions modestly improved adherence but showed limited impact on treatment outcomes (Davis et al., 2024). Similarly, a randomized controlled trial in China reported only minimal reduction in loss to follow-up with digital adherence technologies and no significant improvement in treatment success (Liu et al., 2023). Device-based innovations have also been explored, such as a smart pillbox developed in Egypt that reduced missed doses but lacked disease-specific ((Minaam & Abd-ELfattah, 2018)), an electronic pillbox in Indonesia that improved adherence without automated dispensing features (Mahardiananta et al., 2022), and a real-time monitoring system in India that still faced technical and usability challenges (Charles et al., 2024).

Given the existing limitations of current digital adherence technologies, this study developed and evaluated the SMART-ADHERENCE PILLBOX (SAP), an integrated electronic automatic pillbox combining medication reminders, automated dispensing, electronic logging, and real-time monitoring. The study aimed to assess the technical reliability, operational performance, patient acceptability, and preliminary effectiveness of SAP in improving medication adherence among tuberculosis patients during the intensive treatment phase.

To the best of our knowledge, this study represents the first attempt to develop and evaluate the SMART-ADHERENCE PILLBOX (SAP), an integrated digital adherence technology that combines automated medication dispensing, real-time monitoring, electronic logging, and adherence-based notification systems for tuberculosis (TB) patients in Indonesia. The results demonstrated excellent technical performance, high user acceptability, and significant improvements in medication-taking behavior following SAP implementation. These findings suggest that SAP may offer a feasible and scalable approach to supporting adherence among TB patients, while providing a foundation for future large-scale evaluations of digitally assisted tuberculosis care.

The technical validation results showed that SAP exhibited stable operational performance across all tested domains, with success rates exceeding 95% for alarm activation, medication dispensing, notification delivery, connectivity, and electronic logging throughout four independent replications. System stability is a critical component of technologies designed to support adherence in chronic disease management because minor disruptions in reminder or dispensing systems may lead to delayed medication intake, reduced adherence, and ultimately treatment failure (Charles et al., 2024). Furthermore, the absence of repeated over-dispensing events indicates that SAP may contribute to medication safety in TB therapy, where dosing accuracy is essential to prevent treatment failure, adverse drug reactions, and antimicrobial resistance.

The timing performance of SAP was also highly satisfactory. Alarm and logging deviations were close to zero, indicating highly accurate synchronization between medication schedules and system operation (Pande et al., 2026). Timely medication intake is particularly important in TB treatment to maintain consistent drug exposure and reduce the risk of resistance development in Mycobacterium tuberculosis (Hasan et al., 2019). In addition, notification delivery times consistently remained below five seconds, demonstrating effective real-time monitoring capability despite minor delayed synchronization events during several operational cycles. These delays did not result in system or notification failures, suggesting that SAP maintained functional stability under varying network conditions.

This study further demonstrated that SAP implementation was associated with significant improvements in medication adherence among TB patients. Following 14 days of SAP use, adherence rates increased from 83.9% to 97.4%, accompanied by reductions in missed doses and medication-taking delays. Improvements were also observed in on-time streak and time-to-first lapse, indicating greater consistency in medication-taking behavior after intervention. These findings are clinically important because medication adherence remains a major challenge in global TB control programs (Sazali et al., 2022). Non-adherence to anti-tuberculosis therapy has been associated with treatment failure, relapse, ongoing transmission, and the emergence of multidrug-resistant tuberculosis (MDR-TB) (Santosa et al., 2025).

Several mechanisms may explain the observed improvement in adherence following SAP implementation. The audio-visual reminder system may help reduce forgetfulness, one of the most common causes of non-adherence during long-term therapy (Fenerty et al., 2012). In addition, electronic logging and real-time monitoring may enhance patients’ self-awareness regarding their medication-taking behavior (Chai et al., 2022). Notifications sent to caregivers and researchers may also provide additional reinforcement to support adherence (Ridho et al., 2021). Social and behavioral support has previously been recognized as an important determinant of successful TB treatment, particularly during the intensive phase of therapy (Sariem et al., 2019).

The improvement in medication-taking timeliness observed in this study is also noteworthy. Following SAP implementation, the mean medication-taking time deviation decreased substantially, indicating that SAP not only improved whether patients took their medication but also improved when they took it. Consistent medication timing may help maintain stable drug concentrations, which is particularly important in prolonged TB treatment, although pharmacokinetic outcomes were not directly assessed in this study (Crabtree-Ramírez et al., 2022).

The acceptability evaluation revealed positive perceptions of SAP across all UTAUT domains. High scores in performance expectancy suggest that patients perceived SAP as beneficial in supporting treatment adherence, whereas high trust scores indicate confidence in the reliability of the system during daily use (Zhang et al., 2025). High behavioral intention and use behavior scores further indicate participants’ willingness to continue using SAP. User acceptance is a crucial factor in the sustainability of digital health interventions because systems perceived as difficult or impractical are less likely to achieve meaningful clinical benefits (Hussain et al., 2025). Although slightly lower scores were observed in the habit and price value domains, these findings still reflect positive acceptability and may indicate the need for adaptation to new technologies and consideration of future implementation costs.

Compared with previous smart pillbox and digital adherence technology studies, SAP offers several advantages by integrating reminders, medication dispensing, electronic logging, and real-time notifications into a single system. Most previous interventions focused primarily on reminder functions or electronic monitoring, whereas TB adherence interventions have commonly relied on SMS reminders, video-observed therapy, or direct observation, all of which require substantial resources (Ridho et al., 2021). The peer-support notification feature incorporated into SAP may further strengthen adherence supervision without requiring continuous direct observation by healthcare providers, making it particularly suitable for resource-limited healthcare settings (Musiimenta et al., 2019).

This study has several strengths, including the use of four independent validation replications, the combination of technical and clinical feasibility assessments, the evaluation of multiple adherence indicators, and the application of a UTAUT-based acceptability framework that provides a comprehensive understanding of user acceptance.

Nevertheless, several limitations should be acknowledged. The relatively small sample size and short intervention period of only 14 days may limit the generalizability of the findings and do not allow assessment of long-term adherence sustainability. Prototype testing was also conducted under laboratory conditions with relatively stable Wi-Fi connectivity, which may not fully represent real-world operational environments. Furthermore, SAP was not compared with other adherence-monitoring technologies or conventional adherence-support methods. Despite these limitations, this study provides preliminary evidence regarding the feasibility, acceptability, and potential effectiveness of SAP as a digital adherence support system for TB treatment. Future studies involving larger sample sizes, longer monitoring periods, cost-effectiveness evaluations, and integration with cloud-based healthcare systems are warranted to further evaluate the broader implementation of SAP.

The SMART-ADHERENCE PILLBOX (SAP) demonstrated high technical reliability and was associated with significant improvements in medication adherence, missed-dose reduction, and medication-taking timeliness among tuberculosis patients. In addition, SAP was well accepted by patients, suggesting its potential as a feasible digital adherence technology for supporting tuberculosis treatment in Indonesia. However, given the limited sample size and single-center study setting, these findings should be interpreted as preliminary and require confirmation in larger multicenter studies before broader generalization and implementation can be recommended.

The authors thank the Purwokerto Pulmonary Clinic, all participating tuberculosis patients, and everyone involved in the development and testing of the SMART-ADHERENCE PILLBOX (SAP) for their valuable support and contributions to this study.

Conceptualization, methodology, software development, prototype design, data collection, formal analysis, investigation, and manuscript drafting were performed by the first author. Supervision, study design validation, methodology review, and critical revision of the manuscript were conducted by the second and third authors. Technical consultation, data interpretation, and manuscript review were provided by all authors. All authors contributed to the development of the SMART-ADHERENCE PILLBOX (SAP), reviewed the final version of the manuscript, and approved its submission for publication.

The authors declare that there are no conflicts of interest regarding the publication of this paper. The authors have no financial, commercial, or personal relationships that could have appeared to influence the work reported in this study.

This study was conducted in accordance with the ethical principles of the Declaration of Helsinki and complied with the WHO 2011 ethical standards and the 2016 Council for International Organizations of Medical Sciences (CIOMS) guidelines. Ethical approval was obtained from the Health Research Ethics Committee of Universitas Harapan Bangsa, Indonesia (Approval No. B.LPPM-UHB/1325/12/2025). The study was approved based on the fulfillment of seven WHO ethical standards, including social value, scientific value, equitable assessment of benefits and risks, risk management, persuasion/exploitation prevention, confidentiality and privacy protection, and informed consent. Prior to participation, all patients received detailed information regarding the study objectives, procedures, potential risks, and benefits, and provided written informed consent. Participant confidentiality and anonymity were maintained throughout the study, and all collected data were used exclusively for research purposes.