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VDOT for Monitoring Adherence to LTBI Treatment

NCT02641106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2021-02-05

No results posted yet for this 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.

Conditions

Interventions

OTHER

Video Directly Observed Therapy

Video Directly Observed Therapy (VDOT) is a novel means of remotely observing patients ingesting medications using videos sent from a smartphone. VDOT was developed and found to be feasible and acceptable for monitoring daily treatment of active TB in San Diego, CA and Tijuana, B.C., Mexico (R21-AI088326; PI: R. Garfein). Patients are taught how to use the VDOT recording app, record medication ingestion, and contact their physician when side effects occur. Participants are trained at the time of their first LTBI treatment dose to ensure participants know how to record videos. All remaining 11 weekly doses are taken and recorded wherever the participant chooses. Clinic staff monitor videos as they arrive using a password protected website and document each medication dose that is taken.

OTHER

In-Person DOT

Clinic-based, in-person DOT is the standard of care for monitoring adherence for patients taking the 12-dose isoniazid/rifapentine treatment for LTBI. Participants visit the clinic once weekly until all 12 doses are taken or 16 weeks pass, whichever comes first.

Sponsors & Collaborators

Principal Investigators

  • Richard S Garfein, PhD, MPH · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-08
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02641106 on ClinicalTrials.gov