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Tuberculosis Treatment Adherence Using Digital Reminders
- BDCTR ID
- BDCTR-2026-000085
- Sponsor
- Bangladesh Medical University
- Information provided by
- Dr Afroza Sultana (Responsible Party)
- Last Update Posted
- 2026-07-28
Completed
No longer looking for participants
Study Record Versions
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| Select | Version | Date submitted (YYYY-MM-DD) | Changes |
|---|---|---|---|
| 2 | 2026-07-28Current |
|
Select two versions to compare.
Viewing V2 (2026-07-28)
Study Details
Study Identification
| Unique Protocol ID | BMU-MED-2026-005 |
|---|---|
| Brief Title | Tuberculosis Treatment Adherence Using Digital Reminders (TB-DIGITAL) |
| Official Title | Digital Adherence Technology With SMS Reminders Versus Directly Observed Therapy for Tuberculosis Treatment Completion |
| Secondary IDs |
Study Status
| Record Verification | 2026-07 |
|---|---|
| Overall Status | Completed |
| Study Start | 2025-09-01 |
| Primary Completion | 2026-05-31 |
| Study Completion | 2026-06-30 |
| First Submitted | |
| First Submitted that Met QC Criteria | 2025-08-28 |
| First Posted | 2025-08-28 [Actual] |
| Last Update Submitted that Met QC Criteria | 2026-07-28 |
| Last Update Posted | 2026-07-28 [Actual] |
Sponsor/Collaborators
| Sponsor | Bangladesh Medical University |
|---|---|
| Responsible Party | Dr Afroza Sultana |
| Collaborators | National Tuberculosis Control Programme |
Oversight
| U.S. FDA-regulated Drug | |
|---|---|
| U.S. FDA-regulated Device | |
| Product manufactured in and exported from the U.S. | |
| Data Monitoring | Yes |
Study Description
| Brief Summary | This trial compared digital adherence technology with SMS reminders against standard directly observed therapy on tuberculosis treatment completion. |
|---|---|
| Detailed Description | Adults starting tuberculosis treatment were randomised to digital adherence technology with SMS reminders or directly observed therapy. Treatment completion was the primary endpoint. |
Conditions
| Condition | Tuberculosis |
|---|---|
| Keywords | tuberculosis adherence digital health SMS |
Study Design
| Study Type | Interventional |
|---|---|
| Primary Purpose | Treatment |
| Study Phase | |
| Interventional Study Model | Parallel Assignment |
| Number of Arms | 2 |
| Masking | None (Open Label) |
| Allocation | Randomized |
| Enrollment | 740 [Estimated] |
Arms and Interventions
| Arms | Assigned Interventions |
|---|---|
| Experimental: Digital adherence | Behavioral: Digital adherence technology with SMS Medication sleeves with daily SMS reminders. |
| Active Comparator: Directly observed therapy |
Outcome Measures
| Primary Outcome Measures | Treatment completion rate Time Frame: End of therapy, up to 6 months |
|---|---|
| Secondary Outcome Measures | Loss to follow-up Time Frame: Up to 6 months |
Eligibility
| Minimum Age | 18 Years |
|---|---|
| Maximum Age | |
| Ages | 18 Years and older (Adult, Older Adult) |
| Sex | All |
| Gender-based Eligibility | |
| Gender Eligibility Description | |
| Accepts Healthy Volunteers | No |
| Criteria | <p>Inclusion Criteria:</p><ul><li>Adults starting first-line tuberculosis treatment.</li><li>Access to a mobile phone.</li></ul><p>Exclusion Criteria:</p><ul><li>Drug-resistant tuberculosis.</li></ul> |
Contacts/Locations
| Central Contact Person | Dr Afroza Sultana tb-adherence@bmu.ac.bd |
|---|---|
| Study Officials | |
| Location | Rangpur, Rangpur, Bangladesh, 5400 Status: Completed Facility: Rangpur Medical College Hospital |
IPD Sharing
| IPD information | Plan to Share IPD: Not provided |
|---|
References
| Citations | |
|---|---|
| Links | |
| Available IPD/Information |
Document Section
| Documents |
|---|
Study Results
Participant Flow
Recruitment Details
Adults starting first-line tuberculosis treatment were enrolled at Rangpur Medical College Hospital between September 2025 and February 2026.
Pre-assignment Details
[Not Specified]
Period Title: Overall study
| Arm/Group Title | Digital adherence | Directly observed therapy |
|---|---|---|
| Arm/Group Description | Digital adherence technology with daily SMS reminders. | Standard directly observed therapy. |
| Started | 372 | 368 |
| NOT COMPLETED | 31 | 50 |
| Completed | 341 | 318 |
| Not Completed | 31 | 50 |
| Reason Not Completed | ||
| Lost to Follow-up | 24 | 39 |
| Adverse Event | 7 | 11 |
Baseline Characteristics
| Arm/Group Title | Digital adherence | Directly observed therapy | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Overall Number of Baseline Participants | 372 | 368 | — |
Baseline Analysis Population Description
[Not Specified]
Age, ContinuousMean (Standard Deviation) | Unit of measure: years
| Arm/Group Title | Digital adherence | Directly observed therapy | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Number Analyzed | 372 participants | 368 participants | — |
| Age, Continuous | 38.2 (12.1) | 39.0 (11.8) | — |
Sex: Female, MaleMeasure Type: Count of Participants | Unit of measure: Participants
| Arm/Group Title | Digital adherence | Directly observed therapy | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Number Analyzed | 372 participants | 368 participants | — |
| Female | 151 40.6% | 149 40.5% | 300 |
| Male | 221 59.4% | 219 59.5% | 440 |
Outcome Measures
1. Treatment completion rateType: Primary | Time Frame: End of therapy, up to 6 months
Description
Proportion of participants completing the full course of treatment.
Analysis Population Description
[Not Specified]
| Arm/Group Title | Digital adherence | Directly observed therapy |
|---|---|---|
| Overall Number of Participants Analyzed | 372 | 368 |
| Measure Type: Number | Unit of Measure: percentage of participants | ||
| Treatment completion rate | 91.7 | 86.4 |
2. Loss to follow-upType: Secondary | Time Frame: Up to 6 months
Description
[Not Specified]
Analysis Population Description
[Not Specified]
| Arm/Group Title | Digital adherence | Directly observed therapy |
|---|---|---|
| Overall Number of Participants Analyzed | — | — |
| Measure Type: Number | Unit of Measure: percentage of participants | ||
| Loss to follow-up | 6.5 | 10.6 |
Adverse Events
Time Frame
Up to 6 months
Adverse Event Reporting Description
[Not Specified]
All-Cause Mortality
| Arm/Group Title | Digital adherence | Directly observed therapy |
|---|---|---|
| Affected / at Risk (%) | Affected / at Risk (%) | |
| Total | — | — |
Serious Adverse Events
| Arm/Group Title | Digital adherence | Directly observed therapy | ||
|---|---|---|---|---|
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/372 (2.42%) | 12/368 (3.26%) | ||
| Hepatobiliary disorders | ||||
| Drug-induced hepatotoxicity | 6/372 (1.61%) | 8/368 (2.17%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Severe cutaneous reaction | 3/372 (0.81%) | 4/368 (1.09%) | ||
Other (Not Including Serious) Adverse Events
5% Frequency Threshold for Reporting Other Adverse Events
| Arm/Group Title | Digital adherence | Directly observed therapy | ||
|---|---|---|---|---|
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 61/372 (16.40%) | 68/368 (18.48%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 41/372 (11.02%) | 45/368 (12.23%) | ||
| Nervous system disorders | ||||
| Peripheral neuropathy | 20/372 (5.38%) | 23/368 (6.25%) | ||
Limitations and Caveats
[Not Specified]