NCT04221789Active, not recruiting
TB Treatment Support Tool Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes
TB Treatment Support Tools: Refinement and Evaluation of an Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes
Source: ClinicalTrials.gov · Last updated 21 May 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 555 (actual)
- First submitted
- 6 Jan 2020
- Start date
- 17 Nov 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Institute for Clinical Effectiveness and Health Policy
- Diseases
- Tuberculosis
- NCT number
- NCT04221789
What you commit to
- Study type: Interventional
- Participants enrolled: 555
- From 17 Nov 2020 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Retreatment (default or previous treatment failure)
- Patients with known drug resistance
Other illness
- Patients with known HIV co-infection will be excluded because their care is managed separately.
Age
- Children up to 15 years old
- 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.
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IECS Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.