Treatment Adherence, Tuberculosis
Conditions
Keywords
treatment supervision, success default
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.
Interventions
OTHERTB treatment assistant
Cell phone app to support self administered treatment and monitor adherence
Sponsors
University of Washington
Institute for Clinical Effectiveness and Health Policy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysts will not be aware of group allocation
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Success | 6 months | Number of participants who completed 6 months of treatment and/ or demonstrated a bacteriological cure after 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Default | 6 months | Abandonment of treatment for at least 2 months |
Countries
Argentina
Participant flow
Recruitment details
Between November 2020 and May 2023, a total of 555 individuals were enrolled across four public reference hospitals in Argentina. Of the 1017 individuals assessed for eligibility, 380 were excluded mostly due to retreatment
Participants by arm
| Arm | Count |
|---|---|
| Intervention: TB Treatment Assistant Patients receiving instructions to use phone application | 277 |
| Control Patients receiving instructions for usual care self administered treatment | 278 |
| Total | 555 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | deviation from protoco | 22 | 8 |
Baseline characteristics
| Characteristic | Intervention: TB Treatment Assistant | Control | Total |
|---|---|---|---|
| Age, Continuous | 32.5 years STANDARD_DEVIATION 12.97 | 33.7 years STANDARD_DEVIATION 13.66 | 33.1 years STANDARD_DEVIATION 13.31 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 145 Participants | 135 Participants | 280 Participants |
| Sex: Female, Male Male | 132 Participants | 143 Participants | 275 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 277 | 0 / 278 |
| other Total, other adverse events | 0 / 277 | 0 / 278 |
| serious Total, serious adverse events | 0 / 277 | 0 / 278 |
Outcome results
Primary
Number of Participants With Treatment Success
Number of participants who completed 6 months of treatment and/ or demonstrated a bacteriological cure after 6 months
Time frame: 6 months
Population: No differences
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: TB Treatment Assistant | Number of Participants With Treatment Success | 208 Participants |
| Control | Number of Participants With Treatment Success | 201 Participants |
Comparison: Ho no difference in treatment success between groups. The study was originally powered to detect a 15% difference between groupsp-value: 0.04995% CI: [1.02, 1.2]Chi-squared
Secondary
Treatment Default
Abandonment of treatment for at least 2 months
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: TB Treatment Assistant | Treatment Default | 44 Participants |
| Control | Treatment Default | 66 Participants |
Comparison: Ho No difference between arms. 80% power to detect a 10% differencep-value: <0.04395% CI: [0.5, 0.97]Chi-squared