TuberculosisTB-TSTNCT04221789
TB Treatment Support Tool Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes
A study testing TB treatment assistant in people with Tuberculosis and Treatment Adherence, run by Institute for Clinical Effectiveness and Health Policy at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Tuberculosis, Treatment Adherence
- What is being tested?
- TB treatment assistant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 1 siteArgentina
- Study dates
- 17 Nov 2020to 31 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TB Treatment Support Tools: Refinement and Evaluation of an 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
Read the detailed description
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
- Tuberculosis, Treatment Adherence
- Being tested
- TB treatment assistant
- Keywords
- treatment supervision, success default
- Medical subject headings
- Tuberculosis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB treatment assistantOther
Also called TB-TST (Treatment Support Tools)
Cell phone app to support self administered treatment and monitor adherence
| Study group | Role | What they receive |
|---|---|---|
| intervention: TB treatment assistant | Experimental | Patients receiving instructions to use phone application Receives: Other: TB treatment assistant |
| Control | No intervention | Patients receiving instructions for usual care self administered treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Success
Number of participants who completed 6 months of treatment and/ or demonstrated a bacteriological cure after 6 months
Measured: 6 months
Secondary outcomes (1)
Treatment Default
Abandonment of treatment for at least 2 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start17 Nov 2020
- Primary completion31 Dec 2023
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (83)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness and Health Policy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Fernando A Rubinstein, MD MPH, Principal investigator, Institute for Clinical Effectiveness and Health PolicySarah Iribarren, RN PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221789
- Sponsor's protocol ID
- 12112019
- Acronym
- TB-TST
- Status last verified
- May 2025
- First submitted
- 6 Jan 2020
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization. The top 10 causes of death worldwide. Geneva, 2017.
World Health Organization. Global Tuberculosis Report, 2018.
World Health Organization. Tuberculosis: fact sheet no. 104, Reviewed March 2016, 2016.
All Party Parliamentary Group on Global TB. The price of a pandemic:counting the cost of MDR-TB, 2015.
World Health Organization. End TB Strategy. 2015.
World Health Organization. Digital Health for the End TB Strategy: An Agenda for Action Geneva, Switzerland, 2015.
World Health Organization. Digital health for the End TB strategy: progress since 2015 and future perspectives. Geneva: World Health Organization, 2017.
DiStefano MJ, Schmidt H. mHealth for Tuberculosis Treatment Adherence: A Framework to Guide Ethical Planning, Implementation, and Evaluation. Glob Health Sci Pract. 2016 Jun 27;4(2):211-21. doi: 10.9745/GHSP-D-16-00018. Print 2016 Jun 20.
PubMed 27353615Schnall R, Bakken S, Brown Iii W, Carballo-Dieguez A, Iribarren S. Usabilty Evaluation of a Prototype Mobile App for Health Management for Persons Living with HIV. Stud Health Technol Inform. 2016;225:481-5.
PubMed 27332247Guerra RL, Conde MB, Efron A, Loredo C, Bastos G, Chaisson RE, Golub JE. Point-of-care Arkansas method for measuring adherence to treatment with isoniazid. Respir Med. 2010 May;104(5):754-7. doi: 10.1016/j.rmed.2010.02.001. Epub 2010 Mar 3.
PubMed 20202806Schraufnagel DE, Stoner R, Whiting E, Snukst-Torbeck G, Werhane MJ. Testing for isoniazid. An evaluation of the Arkansas method. Chest. 1990 Aug;98(2):314-6. doi: 10.1378/chest.98.2.314.
PubMed 2376164Kilburn JO, Beam RE, David HL, Sanchez E, Corpe RF, Dunn W. Reagent-impregnated paper strip for detection of metabolic products of isoniazid in urine. Am Rev Respir Dis. 1972 Dec;106(6):923-4. doi: 10.1164/arrd.1972.106.6.923. No abstract available.
PubMed 4641228World Health Organization. Global Tuberculosis Report, 2016. Geneva: World Health Organization, 2016.
Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008 Nov;5(4):193-203. doi: 10.1007/s11904-008-0028-y.
PubMed 18838059Schnall R, Rojas M, Bakken S, Brown W, Carballo-Dieguez A, Carry M, Gelaude D, Mosley JP, Travers J. A user-centered model for designing consumer mobile health (mHealth) applications (apps). J Biomed Inform. 2016 Apr;60:243-51. doi: 10.1016/j.jbi.2016.02.002. Epub 2016 Feb 20.
PubMed 26903153
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TB Treatment Support Tools: Refinement and Evaluation of an Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes
- ClinicalTrials.gov ID
- NCT04221789
- Acronym / sponsor ID
- TB-TST / 12112019
- Conditions
- Tuberculosis, Treatment Adherence
- Keywords
- treatment supervision, success default
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness and Health PolicyUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention: TB treatment assistant | Experimental | Other: TB treatment assistantPatients receiving instructions to use phone application |
| Control | No intervention | –Patients receiving instructions for usual care self administered treatment |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB treatment assistantAlso: TB-TST (Treatment Support Tools)Cell phone app to support self administered treatment and monitor adherence | Other | intervention: TB treatment assistant |
Primary outcome
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
1 secondary outcome
Treatment Default
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundWorld Health Organization. The top 10 causes of death worldwide. Geneva, 2017.
- BackgroundWorld Health Organization. Global Tuberculosis Report, 2018.
- BackgroundWorld Health Organization. Tuberculosis: fact sheet no. 104, Reviewed March 2016, 2016.
- BackgroundAll Party Parliamentary Group on Global TB. The price of a pandemic:counting the cost of MDR-TB, 2015.
- BackgroundWorld Health Organization. End TB Strategy. 2015.
- BackgroundWorld Health Organization. Digital Health for the End TB Strategy: An Agenda for Action Geneva, Switzerland, 2015.
- BackgroundWorld Health Organization. Digital health for the End TB strategy: progress since 2015 and future perspectives. Geneva: World Health Organization, 2017.
- Background: PubMed 27353615DiStefano MJ, Schmidt H. mHealth for Tuberculosis Treatment Adherence: A Framework to Guide Ethical Planning, Implementation, and Evaluation. Glob Health Sci Pract. 2016 Jun 27;4(2):211-21. doi: 10.9745/GHSP-D-16-00018. Print 2016 Jun 20.
- Background: PubMed 27332247Schnall R, Bakken S, Brown Iii W, Carballo-Dieguez A, Iribarren S. Usabilty Evaluation of a Prototype Mobile App for Health Management for Persons Living with HIV. Stud Health Technol Inform. 2016;225:481-5.
- Background: PubMed 20202806Guerra RL, Conde MB, Efron A, Loredo C, Bastos G, Chaisson RE, Golub JE. Point-of-care Arkansas method for measuring adherence to treatment with isoniazid. Respir Med. 2010 May;104(5):754-7. doi: 10.1016/j.rmed.2010.02.001. Epub 2010 Mar 3.
- Background: PubMed 2376164Schraufnagel DE, Stoner R, Whiting E, Snukst-Torbeck G, Werhane MJ. Testing for isoniazid. An evaluation of the Arkansas method. Chest. 1990 Aug;98(2):314-6. doi: 10.1378/chest.98.2.314.
- Background: PubMed 4641228Kilburn JO, Beam RE, David HL, Sanchez E, Corpe RF, Dunn W. Reagent-impregnated paper strip for detection of metabolic products of isoniazid in urine. Am Rev Respir Dis. 1972 Dec;106(6):923-4. doi: 10.1164/arrd.1972.106.6.923. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando A Rubinstein, MD MPH principal investigator
Institute for Clinical Effectiveness and Health Policy
Sarah Iribarren, RN PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TB treatment assistant in people with Tuberculosis and Treatment Adherence, run by Institute for Clinical Effectiveness and Health Policy at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04221789, which also lists 83 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025; AzTrials last refreshed its copy on 29 Oct 2026.