Clinical trial NCT02641106: VDOT for Monitoring Adherence to LTBI Treatment
Official title: Video Directly Observed Therapy (VDOT) to Monitor Short-Course LTBI Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Latent Tuberculosis Infection
Keywords: Telemedicine
Mobile Phone
Adherence
Latent Tuberculosis Infection
Directly Observed Therapy
Video DOT
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 129
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Building on our novel VDOT System that includes text messaging reminders and HIPAA-compliant cloud-based administration, we hypothesize that VDOT can be expanded to provide higher treatment completion rates at a lower cost than in-person DOT for LTBI treatment using 3HP. We propose a randomized controlled trial to address the following specific aims:

Aim 1: To determine whether LTBI treatment completion and adherence are greater for patients treated with 3HP administered via VDOT versus in-person DOT, and to identify patient factors associated with these outcomes; Aim 2: To compare acceptability of treatment by patients on VDOT versus in-person DOT, and identify factors associated with differences in acceptability; Aim 3: To calculate the cost-effectiveness of VDOT compared to in-person DOT for administering 3HP.

To address the study aims we will conduct a randomized controlled trial in which TB contacts and refugees in San Diego who are prescribed 3HP for LTBI treatment by their physician will be randomly assigned to be monitored for adherence via either VDOT or in-person DOT (Figure 2). Approximately 100 patients per year over three years (n=155/arm) will be recruited through the San Diego County TB Control and Refugee Health Program (TCRHP) clinics for the trial. Patients assigned to VDOT will be given a smartphone with service and taught to send videos of themselves taking each weekly medication dose; patients in the in-person DOT arm will visit the clinic each week to be observed by a healthcare worker taking their LTBI medication. Medication adherence will be monitored for all participants until they have taken all 12 doses or 16 weeks (limit recommended by the CDC to complete treatment), to compare treatment adherence rates and patient acceptance across trial arms. Participants will complete brief (20 minute) baseline and follow-up assessment interviews to obtain information about potential confounders and effect modifiers of adherence and patient acceptance regarding their treatment administration method. Cost-benefit analyses will also be conducted to assist in developing policies around the use of VDOT for 3HP. Since participants will be recruited after they have been prescribed 3HP by their healthcare provider and all patient care will be continued through their provider, no medications will be prescribed or treatment decisions made this study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Are younger than 13 years old;
2. Plan to move out of San Diego County within 4 months of enrollment;
3. Refuse to allow study staff to review their medical records;
4. Are incarcerated;
5. 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
6. Are using other medications that preclude the use of 3HP (e.g., antiretroviral medication for HIV).

Primary outcomes:
measure: Proportion of participants completing LTBI treatment
timeFrame: 16 weeks
measure: Participant satisfaction with method of monitoring LTBI treatment
timeFrame: 16 weeks
measure: cost-effectiveness of VDOT compared to in-person DOT for administering 3HP
timeFrame: 5 years
Secondary outcomes:
measure: Proportion of participants completing LTBI treatment in 12 weeks
timeFrame: 12 weeks
measure: Proportion of participants who took all 12 LTBI treatment doses on-schedule
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego County Health and Human Services Agency
state: California
Study officials:
affiliation: University of California, San Diego
name: Richard S Garfein, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: