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NCT Number: NCT04221789

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Gram-Positive Bacterial Infections Health Behavior Infections Mycobacterium Infections Treatment Adherence Treatment Adherence and Compliance

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IECS

Buenos Aires, 1414, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

TB treatment assistant

Other

Cell phone app to support self administered treatment and monitor adherence

Other names: TB-TST (Treatment Support Tools)

Primary outcomes

  1. Number of Participants With Treatment Success

    Time frame: 6 months

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

Secondary outcomes

  1. Treatment Default

    Time frame: 6 months

    Abandonment of treatment for at least 2 months

Sponsors and collaborators

Lead sponsor

Institute for Clinical Effectiveness and Health Policy

Other

Collaborators

  • University of Washington

Registry information

Official study title

TB Treatment Support Tools: Refinement and Evaluation of an Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes

Acronym: TB-TST

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Jan 9, 2020
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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