PMID- 34152281 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231107 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 10 IP - 6 DP - 2021 Jun 21 TI - Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial. PG - e28094 LID - 10.2196/28094 [doi] LID - e28094 AB - 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. CI - (c)Sarah Iribarren, Hannah Milligan, Kyle Goodwin, Omar Alfonso Aguilar Vidrio, Cristina Chirico, Hugo Telles, Daniela Morelli, Barry Lutz, Jennifer Sprecher, Fernando Rubinstein. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 21.06.2021. FAU - Iribarren, Sarah AU - Iribarren S AUID- ORCID: 0000-0003-2980-0717 AD - Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, United States. FAU - Milligan, Hannah AU - Milligan H AUID- ORCID: 0000-0003-3167-8263 AD - Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, United States. FAU - Goodwin, Kyle AU - Goodwin K AUID- ORCID: 0000-0002-8314-6472 AD - Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, United States. FAU - Aguilar Vidrio, Omar Alfonso AU - Aguilar Vidrio OA AUID- ORCID: 0000-0001-9942-699X AD - Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, United States. FAU - Chirico, Cristina AU - Chirico C AUID- ORCID: 0000-0002-5694-3396 AD - National Tuberculosis Control Program, Region Five, Buenos Aires Argentina, Buenos Aires, Argentina. FAU - Telles, Hugo AU - Telles H AUID- ORCID: 0000-0003-3830-8847 AD - National Tuberculosis Control Program, Region Five, Buenos Aires Argentina, Buenos Aires, Argentina. FAU - Morelli, Daniela AU - Morelli D AUID- ORCID: 0000-0001-6387-6083 AD - Institute of Clinical Effectiveness and Healthcare Policy, Buenos Aires, Argentina. FAU - Lutz, Barry AU - Lutz B AUID- ORCID: 0000-0003-4298-4901 AD - Department of Bioengineering, University of Washington, Seattle, WA, United States. FAU - Sprecher, Jennifer AU - Sprecher J AUID- ORCID: 0000-0003-2191-7945 AD - Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, United States. FAU - Rubinstein, Fernando AU - Rubinstein F AUID- ORCID: 0000-0001-5653-5766 AD - Institute of Clinical Effectiveness and Healthcare Policy, Buenos Aires, Argentina. LA - eng SI - ClinicalTrials.gov/NCT04221789 GR - K23 NR017210/NR/NINR NIH HHS/United States GR - R01 AI147129/AI/NIAID NIH HHS/United States PT - Journal Article DEP - 20210621 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC8277351 OTO - NOTNLM OT - digital health OT - direct drug metabolite test OT - disease management OT - infectious disease OT - mHealth OT - mobile phone OT - tuberculosis COIS- Conflicts of Interest: Some of the authors are developers (SI, KG, and OAAV) and evaluators (SI, HM, CC, HT, and FR) of the software. EDAT- 2021/06/22 06:00 MHDA- 2021/06/22 06:01 PMCR- 2021/06/21 CRDT- 2021/06/21 12:16 PHST- 2021/02/20 00:00 [received] PHST- 2021/03/30 00:00 [accepted] PHST- 2021/03/30 00:00 [revised] PHST- 2021/06/21 12:16 [entrez] PHST- 2021/06/22 06:00 [pubmed] PHST- 2021/06/22 06:01 [medline] PHST- 2021/06/21 00:00 [pmc-release] AID - v10i6e28094 [pii] AID - 10.2196/28094 [doi] PST - epublish SO - JMIR Res Protoc. 2021 Jun 21;10(6):e28094. doi: 10.2196/28094.