Factors related to the utilization of digital adherence technologies in tuberculosis care: A qualitative study among adults in DS-TB treatment, health care providers and other key actors in Tanzania.

Numerous challenges, such as lengthy treatment course, side effects, and distance to healthcare facilities contribute to suboptimal Tuberculosis (TB) treatment completion. Digital adherence technologies (DATs), such as smart pillboxes and medication labels, could be an alternative to facilitate TB treatment continuation. In-depth interviews with people undergoing treatment for drug susceptible TB, health care providers (HCPs) and other key actors were conducted to evaluate their experiences with DATs in ten health facilities across four different regions in Tanzania. This study is part of a multi country cluster randomized trials conducted under the ASCENT consortium. Interviews were conducted with a total of 41 individuals, 19 people with TB and 22 HCPs and key actors. One of the main findings indicates that participants found that the daily reminders provided by the DATs, particularly the alarm from the smart pillboxes, helped in supporting treatment continuation and establishing a routine around medicine intake. DATs use was linked with reducing the financial burden of treatment, improving people with TB-HCPs relationship, and decreasing workload for HCPs. Although DATs were generally perceived as reliable, occasional technical malfunctions, such as battery depletion in smart pillboxes, were reported. The requirement of having access to a cellphone and a power source emerged as specific barriers for medication label users. This study highlights the initial willingness and sustained enthusiasm for using DATs among respondents. DATs were perceived as useful tools, aiding individuals with treatment continuation through daily reminders and fostering stronger connections with HCPs. Nevertheless, issues such as poor network connectivity and the need for access to a working cellphone posed difficulties in usage. Findings from this study suggest the potential for improvements in the technologies and indicate that a thorough assessment of people's life conditions and needs prior to treatment initiations is important to determine the suitability of providing a DAT.

Digital Adherence Technologies and Differentiated Care for Tuberculosis Treatment and Their Acceptability Among Persons With Tuberculosis, Health Care Workers, and Key Informants in the Philippines: Qualitative Interview Study.

BACKGROUND: Digital adherence technologies (DATs) are being studied to determine their potential to support tuberculosis (TB) treatment and address the shortcomings of directly observed therapy. Previous research has shown inconclusive results on whether DATs can enhance medication adherence among persons with TB. OBJECTIVE: This study aims to understand the acceptability of DATs, namely, medication labels and smart pillboxes, among persons with TB, health care workers (HCWs), and key informants (KIs) in the Philippines. The objective is to gain valuable insights that can inform the design and implementation of DATs in the Southeast Asian region, which meet the needs and preferences of end users. METHODS: Persons with TB, HCWs, and KIs were recruited from intervention facilities to participate in in-depth interviews conducted between March 2022 and January 2023. These interviews were transcribed and translated into English. A thematic analysis was carried out using NVivo software (Lumivero) to identify and analyze themes. Themes were then structured within a modified social-ecological model. RESULTS: A total of 25 persons with drug-sensitive TB and 20 HCWs or KIs were interviewed. Both groups emphasized that users' technology literacy level, financial conditions, and motivation to be cured determined how they interacted with the DAT. They also acknowledged that DATs helped foster their relationship with HCWs and enabled efficient treatment support. Concerning technology, persons with TB found DATs easy to use and able to reduce clinic visits. HCWs mentioned that DATs added to their workload but also allowed them to support users who missed doses. However, both groups experienced technical challenges with DATs. Regarding program implementation, users appreciated the clear explanations and demonstrations provided by HCWs. Yet, some users reported inconsistencies between DAT settings and the information provided. HCWs stressed the importance of comprehensive training and sufficient resources for effective program implementation in the future. At the community level, both groups noted that DATs and program design protected users' privacy and reduced the risk of stigma. Finally, users and HCWs shared various contextual factors that influenced their experience with DAT, including infrastructure challenges and the impact of the COVID-19 pandemic. CONCLUSIONS: In the Philippines, persons with TB and HCWs showed a high level of acceptance and satisfaction with the impact of DAT and program design. They expressed a desire for the continuation of DATs. The challenges encountered underscore the need for ongoing technological development to minimize malfunctions, enhance the capacity of health facilities, and improve infrastructure. DATs have demonstrated their ability to strengthen user-HCW relationships and protect users from stigmatization. Additional efforts are required to scale up the DAT program in the Philippines.

Feasibility and acceptability of the smart pillbox and medication label with differentiated care to support person-centered tuberculosis care among ASCENT trial participants - A multicountry study.

Introduction: Digital adherence technologies (DATs) can offer alternative approaches to support tuberculosis treatment medication adherence. Evidence on their feasibility and acceptability in high TB burden settings is limited. We conducted a cross-sectional survey among adults with drug-sensitive tuberculosis (DS-TB), participating in pragmatic cluster-randomized trials for the Adherence Support Coalition to End TB project in Ethiopia (PACTR202008776694999), the Philippines, South Africa and Tanzania (ISRCTN 17706019). Methods: From each country we selected 10 health facilities implementing the DAT intervention (smart pillbox or medication labels, with differentiated care support), ensuring inclusion of urban/rural and public/private facilities. Adults on DS-TB regimen using a DAT were randomly selected from each facility. Feasibility of the DATs was assessed using a standardized tool. Acceptability was measured using a 5-point Likert-scale, using the Capability, Opportunity, Motivation, Behavior (COM-B) model. Mean scores of Likert-scale responses within each COM-B category were estimated, adjusted for facility-level clustering. Data were summarized by country and DAT type. Results: Participants using either the pillbox (n = 210) or labels (n = 169) were surveyed. Among pillbox users, phone ownership (79%), use of pillbox reminders (87%) and taking treatment without the pillbox (22%) varied by country. Among label users, phone ownership (81%), paying extra to use the labels (8%) and taking treatment without using labels (41%) varied by country. Poor network, problems with phone charging and access, not having the pillbox and forgetting to send text were reasons for not using DATs. Overall, people with TB had a favorable impression of both DATs, with mean composite scores between 4·21 to 4·42 across COM-B categories. Some disclosure concerns were reported. Conclusion: From client-perspective, pillboxes and medication labels with differentiated care support were feasible to implement and acceptable in variety of settings. However, implementation challenges related to network, phone access, stigma, additional costs to people with TB to use DATs need to be addressed.

Evaluating the equity impact and cost-effectiveness of digital adherence technologies with differentiated care to support tuberculosis treatment adherence in Ethiopia: protocol and analysis plan for the health economics component of a cluster randomised trial.

BACKGROUND: Tuberculosis remains a leading infectious cause of death in resource-limited settings. Effective treatment is the cornerstone of tuberculosis control, reducing mortality, recurrence and transmission. Supporting treatment adherence through facility-based observations of medication taking can be costly to providers and patients. Digital adherence technologies (DATs) may facilitate treatment monitoring and differentiated care. The ASCENT-Ethiopia study is a three-arm cluster randomised trial assessing two DATs with differentiated care for supporting tuberculosis treatment adherence in Ethiopia. This study is part of the ASCENT consortium, assessing DATs in South Africa, the Philippines, Ukraine, Tanzania and Ethiopia. The aim of this study is to determine the costs, cost-effectiveness and equity impact of implementing DATs in Ethiopia. METHODS AND DESIGN: A total of 78 health facilities have been randomised (1:1:1) into one of two intervention arms or a standard-of-care arm. Approximately 50 participants from each health facility will be enrolled on the trial. Participants in facilities randomised to the intervention arms are offered a DAT linked to the ASCENT adherence platform for daily adherence monitoring and differentiated response for those who have missed doses. Participants at standard-of-care facilities receive routine care. Treatment outcomes and resource utilisation will be measured for each participant. The primary effectiveness outcome is a composite index of unfavourable end-of-treatment outcomes (lost to follow-up, death or treatment failure) or treatment recurrence within 6 months of end-of-treatment. For the cost-effectiveness analysis, end-of-treatment outcomes will be used to estimate disability-adjusted life years (DALYs) averted. Provider and patient cost data will be collected from a subsample of 5 health facilities per study arm, 10 participants per facility (n = 150). We will conduct a societal cost-effectiveness analysis using Bayesian hierarchical models that account for the individual-level correlation between costs and outcomes as well as intra-cluster correlation. An equity impact analysis will be conducted to summarise equity efficiency trade-offs. DISCUSSION: Trial enrolment is ongoing. This paper follows the published trial protocol and describes the protocol and analysis plan for the health economics work package of the ASCENT-Ethiopia trial. This analysis will generate economic evidence to inform the implementation of DATs in Ethiopia and globally. TRIAL REGISTRATION: Pan African Clinical Trial Registry (PACTR) PACTR202008776694999. Registered on 11 August 2020,  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241 .

Effectiveness of digital adherence technologies in improving tuberculosis treatment outcomes in four countries: a pragmatic cluster randomised trial protocol.

INTRODUCTION: Successful treatment of tuberculosis depends to a large extent on good adherence to treatment regimens, which relies on directly observed treatment (DOT). This in turn requires frequent visits to health facilities. High costs to patients, stigma and burden to the health system challenged the DOT approach. Digital adherence technologies (DATs) have emerged as possibly more feasible alternatives to DOT but there is conflicting evidence on their effectiveness and feasibility. Our primary objective is to evaluate whether the implementation of DATs with daily monitoring and a differentiated response to patient adherence would reduce poor treatment outcomes compared with the standard of care (SOC). Our secondary objectives include: to evaluate the proportion of patients lost to follow-up; to compare effectiveness by DAT type; to evaluate the feasibility and acceptability of DATs; to describe factors affecting the longitudinal engagement of patients with the intervention and to use a simple model to estimate the epidemiological impact and cost-effectiveness of the intervention from a health system perspective. METHODS AND ANALYSIS: This is a pragmatic two-arm cluster-randomised trial in the Philippines, South Africa, Tanzania and Ukraine, with health facilities as the unit of randomisation. Facilities will first be randomised to either the DAT or SOC arm, and then the DAT arm will be further randomised into medication sleeve/labels or smart pill box in a 1:1:2 ratio for the smart pill box, medication sleeve/label or the SOC respectively. We will use data from the digital adherence platform and routine health facility records for analysis. In the main analysis, we will employ an intention-to-treat approach to evaluate treatment outcomes. ETHICS AND DISSEMINATION: The study has been approved by the WHO Research Ethics Review Committee (0003296), and by country-specific committees. The results will be shared at national and international meetings and will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN17706019.

Evaluation of implementation and effectiveness of digital adherence technology with differentiated care to support tuberculosis treatment adherence and improve treatment outcomes in Ethiopia: a study protocol for a cluster randomised trial.

BACKGROUND: Digital adherence technologies (DATs) are recommended to support patient-centred, differentiated care to improve tuberculosis (TB) treatment outcomes, but evidence that such technologies improve adherence is limited. We aim to implement and evaluate the effectiveness of smart pillboxes and medication labels linked to an adherence data platform, to create a differentiated care response to patient adherence and improve TB care among adult pulmonary TB participants. Our study is part of the Adherence Support Coalition to End TB (ASCENT) project in Ethiopia. METHODS/DESIGN: We will conduct a pragmatic three-arm cluster-randomised trial with 78 health facilities in two regions in Ethiopia. Facilities are randomised (1:1:1) to either of the two intervention arms or standard of care. Adults aged ≥ 18 years with drug-sensitive (DS) pulmonary TB are enrolled over 12 months and followed-up for 12 months after treatment initiation. Participants in facilities randomised to either of the two intervention arms are offered a DAT linked to the web-based ASCENT adherence platform for daily adherence monitoring and differentiated response to patient adherence for those who have missed doses. Participants at standard of care facilities receive routine care. For those that had bacteriologically confirmed TB at treatment initiation and can produce sputum without induction, sputum culture will be performed approximately 6 months after the end of treatment to measure disease recurrence. The primary endpoint is a composite unfavourable outcome measured over 12 months from TB treatment initiation defined as either poor end of treatment outcome (lost to follow-up, death, or treatment failure) or treatment recurrence measured 6 months after the scheduled end of treatment. This study will also evaluate the effectiveness, feasibility, and cost-effectiveness of DAT systems for DS-TB patients. DISCUSSION: This trial will evaluate the impact and contextual factors of medication label and smart pillbox with a differentiated response to patient care, among adult pulmonary DS-TB participants in Ethiopia. If successful, this evaluation will generate valuable evidence via a shared evaluation framework for optimal use and scale-up. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202008776694999, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241 , registered on August 11, 2020.