TB Treatment Support Tool Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes

NCT04221789 | Active Not Recruiting Results DMC

• 1 other identifier: 12112019
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to conduct a Randomized Clinical Trial (RCT) to evaluate a tuberculosis treatment support tool (TB-TST), a cellular phone app developed using user-centered design principles and a paper-based drug metabolite urine test strip modified for home use for testing the presence of isoniazid drug metabolites in urine to directly monitor adherence to treatment, to improve treatment outcomes for patients with TB receiving self-administered treatment (SAT). Poor medication adherence to TB regimens, along with challenges in monitoring patients and returning them to treatment, are important contributing factors to poor outcomes and the development of drug resistance. With advances and proliferation of mobile technology platforms, there is substantial interest in the possible use of mobile health (mHealth) interventions to address these challenges. Of the mHealth approaches under investigation for TB adherence monitoring, drug metabolite testing has been identified as the most promising, ethical, and accurate, and the least intrusive and stigmatizing strategy compared to other mobile solutions, yet its potential remains largely unexplored. Additionally, mobile applications (apps) may provide personalized treatment supervision, increase patients' self-management and improve patient-provider communication by offering more advanced functionalities for patient support and monitoring. The existing version of the TB-TST app offers education on TB and its treatment, communication with a care-coordinator, tracks treatment adherence (both by self-reporting and direct metabolite test strip images), self-reports treatment side-effects, and retains patient's "diary" notes. This proposal builds on preliminary work to: 1) Refine the TB-TST intervention based on pilot study findings and apply principles of user-centered design; 2) Evaluate the impact of the TB-TST on treatment outcomes compared to usual care; 3) Assess patient and provider perceptions of the facilitators and barriers to implementation of the TB-TST and synthesize lessons learned with stakeholders and policy makers. Primary outcome will be treatment success. Secondary outcomes will include: treatment default rates, self-reported adherence, technology use and usability. Findings have broader implications not only for TB adherence but disease management more generally and will improve our understanding of how to support patients facing challenging treatment regimens

Conditions

Tuberculosis; Treatment Adherence

Keywords

treatment supervision, success default

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Success

  Number of participants who completed 6 months of treatment and/ or demonstrated a bacteriological cure after 6 months

  6 months

Secondary Outcomes (1)

• Treatment Default

  6 months

Study Arms (2)

intervention: TB treatment assistant

EXPERIMENTAL

Patients receiving instructions to use phone application

Other: TB treatment assistant

Control

NO INTERVENTION

Patients receiving instructions for usual care self administered treatment

Interventions

TB treatment assistant OTHER

Cell phone app to support self administered treatment and monitor adherence

Also known as: TB-TST (Treatment Support Tools)

intervention: TB treatment assistant

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be at least 16 years old,
• have a new diagnosis of drug-susceptible TB,
• First treatment
• have regular access to a smartphone, and
• be able to operate the phone or have someone able to assist.

You may not qualify if:

• Children up to 15 years old
• Retreatment (default or previous treatment failure)
• Patients who are severely ill (i.e., requiring hospitalization)
• Patients who reside in the same household with another study participant
• Inability to operate a smartphone
• Illiteracy (inability to read and write)
• Patients with known drug resistance
• Patients with known HIV co-infection will be excluded because their care is managed separately.
• Case definition: Patients at least 16 year old with TB confirmed by smear-positive sputum or diagnosis of pulmonary TB based on radiological findings and clinical signs and symptoms but with negative sputum smear. The diagnosis may be confirmed by other methods, such as, MGIT960, BACTEC 9000 or MB Bact, nucleic acid amplification (PCR) or ELISA.

Sponsors & Collaborators

• Institute for Clinical Effectiveness and Health Policy: lead
• University of Washington: collaborator

Study Sites (1)

IECS

Buenos Aires, 1414, Argentina

Location

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  PMID: 40897502 DERIVED

• Iribarren S, Milligan H, Goodwin K, Aguilar Vidrio OA, Chirico C, Telles H, Morelli D, Lutz B, Sprecher J, Rubinstein F. Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jun 21;10(6):e28094. doi: 10.2196/28094.

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MeSH Terms

Conditions

Tuberculosis; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Health Behavior; Behavior

Results Point of Contact

• Title: Dr Fernando Rubinstein
• Organization: IECS

frubinstein@iecs.org.ar

01147778767

Study Officials

• Fernando A Rubinstein, MD MPH

  Institute for Clinical Effectiveness and Health Policy

  PRINCIPAL INVESTIGATOR

• Sarah Iribarren, RN PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will not be aware of group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: November 17, 2020
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2025
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)