VDOT for Monitoring Adherence to LTBI Treatment
- Conditions
- Latent Tuberculosis InfectionTuberculosis
- Interventions
- Other: Video Directly Observed TherapyOther: In-Person DOT
- Registration Number
- NCT02641106
- Lead Sponsor
- University of California, San Diego
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Video Directly Observed Therapy Video Directly Observed Therapy 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. In-Person DOT In-Person DOT 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.
- Primary Outcome Measures
Name Time Method cost-effectiveness of VDOT compared to in-person DOT for administering 3HP 5 years 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.
Participant satisfaction with method of monitoring LTBI treatment 16 weeks 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.
Proportion of participants completing LTBI treatment 16 weeks 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.
- Secondary Outcome Measures
Name Time Method Proportion of participants who took all 12 LTBI treatment doses on-schedule 12 weeks Proportion of participants completing LTBI treatment on-schedule (i.e., participants took all 12 doses on the same day each week for 12 consecutive, as prescribed). By the end of 12 weeks, participants who ingested 12 doses within 12 weeks on the same day each week will be counted as achieving this outcome; all others will be counted failing this outcome.
Proportion of participants completing LTBI treatment in 12 weeks 12 weeks Proportion of participants completing LTBI treatment on-schedule (i.e., participants took all 12 doses within 12 weeks, as prescribed). By the end of 12 weeks, participants who ingested 12 doses within 12 weeks will be counted as achieving this outcome; all others will be counted failing this outcome.
Trial Locations
- Locations (1)
San Diego County Health and Human Services Agency
🇺🇸San Diego, California, United States