VDOT for Monitoring Adherence to LTBI Treatment

NCT02641106 | Completed

• 1 other identifier: 150155
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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

Tuberculosis; Latent Tuberculosis Infection

Keywords

Telemedicine; Mobile Phone; Adherence; Latent Tuberculosis Infection; Directly Observed Therapy; Video DOT

Outcome Measures

Primary Outcomes (3)

• Proportion of participants completing LTBI treatment

  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.

  16 weeks

• Participant satisfaction with method of monitoring LTBI treatment

  Compare level of participant satisfaction with treatment by each method of treatment monitoring. After the last dose of medication is taken (or at 16 weeks for those who do not complete treatment), follow-up interviews will collect treatment satisfaction outcome data.

  16 weeks

• cost-effectiveness of VDOT compared to in-person DOT for administering 3HP

  Compare the cost of providing DOT by each method of treatment monitoring. Since this outcome requires program costs for delivery of the VDOT intervention, the time frame for collecting all cost data is 4 years.

  5 years

Secondary Outcomes (2)

• Proportion of participants completing LTBI treatment in 12 weeks

  12 weeks

• Proportion of participants who took all 12 LTBI treatment doses on-schedule

  12 weeks

Study Arms (2)

Video Directly Observed Therapy

EXPERIMENTAL

VDOT arm participants use a smartphone to make a video recording of each weekly medication dose ingested using the VDOT mobile phone app. The VDOT app is programmed to send encrypted, time/date stamped videos to a HIPAA-compliant server as soon as the video recorder is stopped. Clinic staff monitor videos as they arrive using a password protected website and document each medication dose that is taken. Dose 1 is observed in-person; doses 2-12 are observed via videos.

Other: Video Directly Observed Therapy

In-Person DOT

ACTIVE COMPARATOR

In-Person DOT arm participants follow standard-of-care procedures for monitoring ingestion of all medication doses. Participants take their first medication dose at the enrollment visit and return to the clinic once weekly to be observed taking the remaining 11 doses of medication until they complete the 12-dose regimen.

Other: In-Person DOT

Interventions

Video Directly Observed Therapy OTHER

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.

Also known as: VDOT

Video Directly Observed Therapy

In-Person DOT OTHER

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.

Also known as: Control

In-Person DOT

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

San Diego County Health and Human Services Agency

San Diego, California, 92110, United States

Location

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis; Directly Observed Therapy

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Richard S Garfein, PhD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: December 29, 2015
• Study Start: March 8, 2016
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

US (1)