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NCT03266003 · ClinicalTrials.gov registry record · NA
An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment
A NA study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- NA
- Development phase
- 216
- Enrollment target
NCT03266003: Completed NA study, sponsored by Centers for Disease Control and Prevention.
NCT03266003 is a NA study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 216 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03266003, a NA study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- NA
- Development phase
- 216 participants
- Enrollment target
Study Summary
This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be implemented to evaluate traditional directly observed therapy (DOT) and electronic forms of DOT (eDOT) for tuberculosis (TB) treatment. The trial will assess whether eDOT that employs electronic communication methods, such as video via computer or cellphone, is a non-inferior approach to monitor TB treatment adherence, compared to traditional in-person DOT (ipDOT), in which a trained person is in the physical presence of patients as anti-TB drugs are ingested. ipDOT is the single best intervention proven to be successful when it comes to TB patients' adherence to therapy (which reduces risk of acquired drug resistance). However, ipDOT is resource intensive and many times challenging to facilitate in-person. If eDOT is found to be non-inferior to ipDOT, health departments and other clinicians might be able to provide eDOT to certain populations of TB patients in a more flexible and potentially cost-saving manner.
Primary Outcome
The proportion of observable medication doses directly observed by staff during in-person DOT and electronic DOT, analyzed using the modified intention-to-treat (Modified ITT) population. The unit of analysis is medication doses.
Interventions
- OTHER Electronic DOT
- OTHER In-person DOT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2017-07-19 |
| Est. Completion | 2020-12-31 |
| Phase | NA |
What the finished NCT03266003 record still lists
NCT03266003 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Electronic DOT is the first listed.
NCT03266003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03266003 about?
NCT03266003 is a clinical study titled "An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment". This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be implemented to evaluate traditional directly observed therapy (DOT) and electr...
What is the current status of trial NCT03266003?
This trial is currently completed. It is a NA study. The enrollment target is 216 participants. The study started on 2017-07-19. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT03266003?
The interventions under investigation include: Electronic DOT (OTHER), In-person DOT (OTHER).
Who is sponsoring clinical trial NCT03266003?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03266003's enrollment target sits among peer trials
216 485th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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