TB Treatment Support Tool Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes
NCT ID: NCT04221789
Last Updated: 2025-05-21
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
555 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-11-17
Study Completion Date
2025-05-31
Brief Summary
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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
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
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Detailed Description
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Tuberculosis remains one of the top ten causes of death globally despite it being largely curable. Patients face many challenges to adhere to treatment and mobile health (mHealth) interventions may address these challenges and support patients to complete their treatment. We will improve an interactive intervention based on the combined input from patients and TB experts and evaluate the intervention's impact on treatment outcomes in a randomized clinical trial. Findings have broader implications not only for TB adherence but disease management more generally and will improve our understanding of how to support patients in challenging treatment regimens.
Conditions
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Tuberculosis
Treatment Adherence
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Data analysts will not be aware of group allocation
Study Groups
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intervention: TB treatment assistant
Patients receiving instructions to use phone application
Group Type
EXPERIMENTAL
TB treatment assistant
Intervention Type
OTHER
Cell phone app to support self administered treatment and monitor adherence
Control
Patients receiving instructions for usual care self administered treatment
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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TB treatment assistant
Cell phone app to support self administered treatment and monitor adherence
Intervention Type
OTHER
Other Intervention Names
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TB-TST (Treatment Support Tools)
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* Screened patients who do not meet study eligibility will have specific screening data (including gender, age and reason for exclusion) entered into the study database to examine reasons for exclusion and feasibility of enrollment criteria.
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.
* 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.
* Screened patients who do not meet study eligibility will have specific screening data (including gender, age and reason for exclusion) entered into the study database to examine reasons for exclusion and feasibility of enrollment criteria.
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.
Minimum Eligible Age
16 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Washington
OTHER
Sponsor Role
collaborator
Institute for Clinical Effectiveness and Health Policy
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Fernando A Rubinstein, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Institute for Clinical Effectiveness and Health Policy
Sarah Iribarren, RN PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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IECS
Buenos Aires, , Argentina
Site Status
Countries
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Argentina
References
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Reference Type
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.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12112019
Identifier Type: -
Identifier Source: org_study_id
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