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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
Trial Contacts
| ContactsICMJE | Contact information is displayed when a study is open for participants to join. |
|---|
Study Record Dates
| First SubmittedICMJE | Not provided |
|---|---|
| First PostedICMJE | 2025-08-28 |
| Results First PostedICMJE | 2026-07-28 |
| Last Update Posted | 2026-07-28 |
| Last Verified* | 2026-07 |
Outcome Measures
| Primary Outcome Measures*ICMJE | Treatment completion rate [Time Frame: End of therapy, up to 6 months] |
|---|---|
| Secondary Outcome Measures[*]ICMJE | Loss to follow-up [Time Frame: Up to 6 months] |
| Other Pre-specified Outcome Measures | Not provided |
Trial Description
| Brief Title*ICMJE | Tuberculosis Treatment Adherence Using Digital Reminders |
|---|---|
| Official Title*§ICMJE | Digital Adherence Technology With SMS Reminders Versus Directly Observed Therapy for Tuberculosis Treatment Completion |
| Acronym[*] | TB-DIGITAL |
| 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. |
| Study Type*ICMJE | Interventional |
| Study Phase*ICMJE | Not provided |
| Study Design*§ICMJE | Allocation: Randomized Interventional Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Condition*ICMJE | Tuberculosis |
| Keywords | tuberculosis adherence digital health SMS |
| Intervention*ICMJE | Behavioral: Digital adherence technology with SMS — Medication sleeves with daily SMS reminders. |
| Study Arms*ICMJE | Experimental: Digital adherence Interventions: Behavioral: Digital adherence technology with SMS Active Comparator: Directly observed therapy |
| Publications | Not provided |
Recruitment Information
| Recruitment Status*ICMJE | Completed |
|---|---|
| Enrollment (Anticipated)*§ICMJE | 740 |
| Study Start Date*§ICMJE | 2025-09-01 |
| Primary Completion Date* | 2026-05-31 (Final data collection date for primary outcome measure) |
| Study Completion Date*§ICMJE | 2026-06-30 |
| Eligibility Criteria*ICMJE | <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> |
| Sex/Gender*ICMJE | Sexes Eligible for Study: All |
| Ages*ICMJE | 18 Years and older (Adult, Older Adult) |
| Accepts Healthy Volunteers*§ICMJE | No |
| Location CountriesICMJE | Bangladesh |
Administrative Information
| BDCTR NumberICMJE | BDCTR-2026-000085 |
|---|---|
| Other Study ID Numbers[*]ICMJE | BMU-MED-2026-005 |
| Has Data Monitoring Committee | Yes |
| Studies a U.S. FDA-regulated Drug Product | Not provided |
| Studies a U.S. FDA-regulated Device Product | Not provided |
| Device Product Not Approved or Cleared by U.S. FDA | Not provided |
| Pediatric Postmarket Surveillance of a Device Product | Not provided |
| Product Manufactured in and Exported from the U.S. | Not provided |
| IPD Sharing StatementICMJE | Plan to Share IPD: Not provided |
| Current Responsible Party* | Dr Afroza Sultana |
| Current Study Sponsor*ICMJE | Bangladesh Medical University |
| CollaboratorsICMJE | National Tuberculosis Control Programme |
| InvestigatorsICMJE | Not provided |
| Registry Account | Imported legacy public registry |
Symbol Legend
- *
- Required
- *§
- Required if Study Start Date is on or after January 18, 2017 — required for every BMU study
- [*]
- Conditionally required
- No Symbol
- Unmarked fields are optional. If no information is provided, fields will be labeled as “Not provided”.
- ICMJE
- Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP