VDOT for Monitoring Adherence to LTBI Treatment

Completed · Not applicable

Conditions studied: Tuberculosis, Latent Tuberculosis Infection

In brief

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.

Key facts

Study ID

NCT02641106

Run by

University of California, San Diego

People needed

129

Starts

2016-03-08

Expected to finish

2020-06-30

Last updated by the study team

2021-02-05

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of LTBI and patient's physician determines that they are eligible to receive 3HP
• Age ≥13 years;
• No plans to move out of the San Diego area within 4 months of enrollment; and
• Willing to comply with study procedures and provide informed consent (or assent for minors and parental consent) prior to study enrollment.

You may not qualify if…

• Are younger than 13 years old;
• Plan to move out of San Diego County within 4 months of enrollment;
• Refuse to allow study staff to review their medical records;
• Are incarcerated;
• Have a physical (e.g., blindness) or cognitive disabilities that make VDOT impractical unless someone else in their household can assist them for the duration of the study; or
• Are using other medications that preclude the use of 3HP (e.g., antiretroviral medication for HIV).

Where it is running

• San Diego County Health and Human Services Agency — San Diego, California, United States

Full record on ClinicalTrials.gov

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