TuberculosisVMALTNCT02641106
VDOT for Monitoring Adherence to LTBI Treatment
A study testing Video Directly Observed Therapy and In-Person DOT in people with Tuberculosis and Latent Tuberculosis Infection, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Latent Tuberculosis Infection
- What is being tested?
- Video Directly Observed Therapy and In-Person DOT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego County Health and Human Services Agency
San Diego, California, 92110
About this study
Official title: Video Directly Observed Therapy (VDOT) to Monitor Short-Course LTBI Treatment
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.
Read the 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.
- Conditions
- Tuberculosis, Latent Tuberculosis Infection
- Being tested
- Video Directly Observed Therapy, In-Person DOT
- Keywords
- Telemedicine, Mobile Phone, Adherence, Latent Tuberculosis Infection, Directly Observed Therapy, Video DOT
- Medical subject headings
- Tuberculosis, Latent Tuberculosis, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Directly Observed TherapyOther
Also called VDOT
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.
In-Person DOTOther
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: In-Person DOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 years
Secondary outcomes (2)
Proportion of participants completing LTBI treatment in 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.
Measured: 12 weeks
Proportion of participants who took all 12 LTBI treatment doses on-schedule
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start8 Mar 2016
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard S Garfein, PhD, University of California, San Diego
- Investigators
- Richard S Garfein, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641106
- Sponsor's protocol ID
- 150155
- Acronym
- VMALT
- Status last verified
- Feb 2021
- First submitted
- 20 Dec 2015
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Directly Observed Therapy (VDOT) to Monitor Short-Course LTBI Treatment
- ClinicalTrials.gov ID
- NCT02641106
- Acronym / sponsor ID
- VMALT / 150155
- Conditions
- Tuberculosis, Latent Tuberculosis Infection
- Keywords
- Telemedicine, Mobile Phone, Adherence, Latent Tuberculosis Infection, Directly Observed Therapy, Video DOT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Directly Observed Therapy | Experimental | Other: Video Directly Observed TherapyVDOT 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 | Active comparator | Other: In-Person DOTIn-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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Directly Observed TherapyAlso: VDOTVideo 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 | Video Directly Observed Therapy |
| In-Person DOTAlso: ControlClinic-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. | Other | In-Person DOT |
Primary outcome
Proportion of participants completing LTBI treatment
Time frame: 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.
Participant satisfaction with method of monitoring LTBI treatment
Time frame: 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.
cost-effectiveness of VDOT compared to in-person DOT for administering 3HP
Time frame: 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.
2 secondary outcomes
Proportion of participants completing LTBI treatment in 12 weeks
Time frame: 12 weeks
Proportion of participants who took all 12 LTBI treatment doses on-schedule
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard S Garfein, PhD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Directly Observed Therapy and In-Person DOT in people with Tuberculosis and Latent Tuberculosis Infection, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants completing LTBI treatment (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.