Patient-centered mobile tuberculosis treatment support tools (TB-TSTs) to improve treatment adherence: A pilot randomized controlled trial exploring feasibility, acceptability and refinement needs.

Background: Digital adherence technologies hold promise to improve patient-centered tuberculosis (TB) monitoring, yet few studies have incorporated direct adherence monitoring or assessed patients' experiences with these technologies. We explored acceptability, feasibility, and refinement needs of the TB Treatment Support Tools (TB-TSTs) intervention linking a mobile app, a urine drug metabolite test, and interactive communication with a treatment supporter. Methods: This pilot study was a parallel-designed single-center randomized controlled trial with exit interviews. Newly diagnosed TB patients were randomized 1:1 using a treatment allocation button in the REDCap software preloaded with a random allocation sequence to usual care or usual care plus the TB-TSTs intervention from a respiratory medicine hospital in the province of Buenos Aires, Argentina and followed for 6-months. Due to the nature of the intervention, blinding to the group allocation could not be achieved for the recruiter or patients. The treatment outcome data extractor was blinded to the group allocation of the participants. Intervention participants used the app to report self-administering medication, potential side effects, submit photos of the urine test, and interact with a treatment supporter. Outcomes were feasibility, acceptability, and treatment outcomes. Findings: Forty-two patients were enrolled and evenly assigned to each group. Intervention participants submitted 147·2±58 (mean, SD) medication self-administration and 144·5±55 side effect reports out of 180 and 47.5±38·4 photos of the urine test out of 77. Treatment success for usual care was 81% [17/21] and 95% [20/21] for the TB-TSTs intervention. Thirty-three themes were identified within the main categories of motivation, what worked, issues experienced, and recommendations. Participants (n=12) rated it as 'easy to use' (4.57/5), 'would highly recommend to others' (4·43/5) and reported that access to the treatment support was a critical component. Recommendations included adding an alarm, appointment reminders, and off-line functionality. Interpretation: Findings suggest that the TB-TSTs intervention was feasible and acceptable and further refinement and testing is warranted. Funding: National Institute of Health K23NR017210.

Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial.

BACKGROUND: Tuberculosis (TB) is an urgent global health threat and the world's deadliest infectious disease despite being largely curable. A critical challenge is to ensure that patients adhere to the full course of treatment to prevent the continued spread of the disease and development of drug-resistant disease. Mobile health interventions hold promise to provide the required adherence support to improve TB treatment outcomes. OBJECTIVE: This study aims to evaluate the effectiveness of the TB treatment support tools (TB-TSTs) intervention on treatment outcomes (success and default) and to assess patient and provider perceptions of the facilitators and barriers to TB-TSTs implementation. METHODS: The TB-TSTs study is an open-label, randomized controlled trial with 2 parallel groups in which 400 adult patients newly diagnosed with TB will be randomly assigned to receive usual care or usual care plus TB-TSTs. Participants will be recruited on a rolling basis from 4 clinical sites in Argentina. The intervention consists of a smartphone progressive web app, a treatment supporter (eg, TB nurse, physician, or social worker), and a direct adherence test strip engineered for home use. Intervention group participants will report treatment progress and interact with a treatment supporter using the app and metabolite urine test strip. The primary outcome will be treatment success. Secondary outcomes will include treatment default rates, self-reported adherence, technology use, and usability. We will assess patients' and providers' perceptions of barriers to implementation and synthesize lessons learned. We hypothesize that the TB-TSTs intervention will be more effective because it allows patients and TB supporters to monitor and address issues in real time and provide tailored support. We will share the results with stakeholders and policy makers. RESULTS: Enrollment began in November 2020, with a delayed start due to the COVID-19 pandemic, and complete enrollment is expected by approximately July 2022. Data collection and follow-up are expected to be completed 6 months after the last patient is enrolled. Results from the analyses based on the primary end points are expected to be submitted for publication within a year of data collection completion. CONCLUSIONS: To our knowledge, this randomized controlled trial will be the first study to evaluate a patient-centered remote treatment support strategy using a mobile tool and a home-based direct drug metabolite test. The results will provide robust scientific evidence on the effectiveness, implementation, and adoption of mobile health tools. The findings have broader implications not only for TB adherence but also more generally for chronic disease management and will improve our understanding of how to support patients facing challenging treatment regimens. TRIAL REGISTRATION: ClinicalTrials.gov NCT04221789; https://clinicaltrials.gov/ct2/show/NCT04221789. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28094.

Insights from participant engagement with the tuberculosis treatment support tools intervention: Thematic analysis of interactive messages to guide refinement to better meet end user needs.

BACKGROUND: Tuberculosis (TB) is a largely curable disease, yet it remains one of the top ten causes of death globally. In response to known challenges to completing the long course of TB treatment, our study team developed the TB treatment support tools (TB-TSTs). The mobile application (app) is comprised of the following main components: 1) tracks treatment progress, 2) provides disease tailored information, 3) interactive communication between patients and treatment supporters, and 4) is linked with a direct adherence drug metabolite test. OBJECTIVE: The objective of this study was to analyze the interactive communication between the patients and the treatment supporter during the TB-TSTs pilot testing to identify issues and guide intervention refinement. METHODS: We used mixed methods to analyze the interactive communication data. The study was conducted at a pulmonary disease specialized hospital in Argentina. Of the 42 study participants enrolled in the pilot study, 21 were randomly assigned to use the TB-TSTs for 6-months during their TB treatment. The treatment supporter was a registered nurse from the regional level of the National TB program. We conducted thematic and content analysis of the messages in their original language, Spanish. We assessed the themes over time and by whom initiated the messages. RESULTS: There were 2561 individual messages sent between the participants and treatment supporter. We identified 19 main themes: 7 were participant and 12 were treatment supporter initiated. Participant themes included missed report rationale, arranging in-person meeting, intervention support, TB treatment progress, disease/treatment questions, side effects and additional support. Treatment supporter themes included missed report inquiry, arranging in-person meeting, introduction and instructions, check-in's, positive reinforcement, treatment progress inquiry, test-strip issues, intervention orientation, initial side-effect check in, follow-up on side effects and photo quality issues. Messages and themes decreased over time with most occurring within the first 2 months of treatment. CONCLUSIONS: Although there was a decrease in the number of messages and the theme types over the 6-month study participation, treatment adherence support remained needed throughout. Potential solutions are suggested for the main issues and recommendations are being used to guide refinement.

El amparo económico para mejorar el tratamiento de la tuberculosis / Economic protection law for improved tuberculosis treatment

Regulatory Decree 170/91 of Law 10436 created a legal framework designed to ensure the socio-economic protection of patients suffering from TB. It consisted of the monthly payment of a minimum salary for employees in the local public administration. The evaluation criteria employed by the health team assessed who could be included in the protection law, their social situation and permanent residence of at least two years in the province of Buenos Aires, Argentina. The aim of our study was to analyze the differences in clinical and epidemiological data between patients included in the law and those not included, and whether the benefit was a factor in the outcome of the treatment. We describe a retrospective observational study that took place from January 1, 2004 to December 31, 2016. People receiving the benefit showed a good outcome in 93.1% of the total cases, 91.1% in confirmed lung cases, 83.7% in the TB-HIV association / AIDS and 81.5% in MDR-TB. In patients not receiving the benefit the success rates were 74.4%, 73.9%, 53.6% and 58.9%, respectively. The differences were statistically significant between both groups. The economic protection law was essential in motivating the patients and in following those cases of difficult management, thus improving treatment adherence. Overcoming TB means not only improving the use of current tools and interventions but also considering the possibility of extending or approving similar laws in Argentina.

Mediante la aprobación del Decreto Reglamentario 170/91 de la Ley 10436, se crea un régimen de amparo, destinado a asegurar la protección socioeconómica del paciente afectado de tuberculosis (TB). Consiste en el pago mensual de un salario básico de la administración pública provincial. El equipo de salud es el que evalúa quiénes se encuentran en condiciones de ser incluidos en la ley de amparo. Los criterios de evaluación contemplan la situación social y una residencia permanente, como mínimo de dos años en la Provincia de Buenos Aires. El objetivo de nuestro estudio es analizar las diferencias de los datos clínicos y epidemiológicos entre pacientes con y sin inclusión en el régimen de amparo y si el subsidio fue factor de éxito en el tratamiento. Este es un estudio observacional retrospectivo, realizado entre el 1º de enero de 2004 al 31 de diciembre de 2016. Las personas con subsidio mostraron éxito en 93.1% en el total de los casos, 91.1% en los casos pulmonares confirmados, 83.7% en la asociación TB-VIH/SIDA y 81.5% en tuberculosis multirresistente (MDR-TB). Sin subsidio el éxito fue 74.4%, 73.9%, 53.6% y 58.9% respectivamente. Las diferencias fueron estadísticamente significativas entre ambos grupos. El régimen de amparo económico, fue primordial para motivar y retener los casos de difícil manejo, mejorando la adhesión al tratamiento. Poner fin a la TB, consistirá, en mejorar el uso de las herramientas e intervenciones actuales y considerar la posibilidad de extender o aprobar leyes similares en el ámbito de nuestro país.