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NCT02641106 · ClinicalTrials.gov registry record · NA

VDOT for Monitoring Adherence to LTBI Treatment

A NA study, sponsored by University of California, San Diego.

Completed
Registry status
NA
Development phase
129
Enrollment target

NCT02641106: Completed NA study, sponsored by University of California, San Diego.

NCT02641106 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 129 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02641106, a NA study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
NA
Development phase
129 participants
Enrollment target

Study Summary

The three-month short-course treatment with isoniazid \[H\] and rifapentine \[P\] (3HP) recently recommended by the Centers for Disease Control and Prevention could dramatically increase the number of persons starting and completing treatment for latent tuberculosis infection (LTBI), but TB providers nationwide are hamstrung by the requirement that 3HP only be administered by directly observed therapy (DOT) in which patients are watched taking each medication dose in-person. We developed a novel mHealth application that allows patients to make and send videos of each medication dose ingested that are watched by healthcare providers via a HIPAA-compliant website to remotely monitor LTBI treatment adherence (Video DOT \[VDOT\]). This study will determine whether monitoring patients with VDOT achieves higher treatment completion rates and greater patient acceptability at lower cost than clinic-based in-person DOT.

Primary Outcome

The proportion of participants completing treatment (i.e., taking all 12 prescribed doses within 16 weeks). At the end of 16 weeks, the participant will have either completed the 12-dose treatment or considered defaulted.

Interventions

  • OTHER Video Directly Observed Therapy
  • OTHER In-Person DOT

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2016-03-08
Est. Completion 2020-06-30
Phase NA
University of California, San Diego

775 total trials

What the finished NCT02641106 record still lists

NCT02641106 is an interventional study that assigns participants to a tested intervention. The registered 129 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 (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Video Directly Observed Therapy is the first listed.

NCT02641106 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02641106 about?

NCT02641106 is a clinical study titled "VDOT for Monitoring Adherence to LTBI Treatment". The three-month short-course treatment with isoniazid \[H\] and rifapentine \[P\] (3HP) recently recommended by the Centers for Disease Control and Prevention could dramatically increase the number of persons starting and completing treatment for latent tuberculosis infection (LTBI), but TB provider...

What is the current status of trial NCT02641106?

This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2016-03-08. Estimated completion is 2020-06-30.

What interventions are being tested in trial NCT02641106?

The interventions under investigation include: Video Directly Observed Therapy (OTHER), In-Person DOT (OTHER).

Who is sponsoring clinical trial NCT02641106?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02641106's enrollment target sits among peer trials

129 744th of 2000 higher than 1,257 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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Source: ClinicalTrials.gov NCT02641106, the US trial registry maintained by the National Library of Medicine. NCT02641106 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.