Clinical trial NCT04221789: TB Treatment Support Tool Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes
Official title: TB Treatment Support Tools: Refinement and Evaluation of an Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tuberculosis
Treatment Adherence
Keywords: treatment supervision, success default
Lead sponsor: Institute for Clinical Effectiveness and Health Policy
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2020-01-09
Enrollment: 555
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Success
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Default
timeFrame: 6 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: IECS
Study officials:
affiliation: Institute for Clinical Effectiveness and Health Policy
name: Fernando A Rubinstein, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Sarah Iribarren, RN PhD
role: PRINCIPAL_INVESTIGATOR
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