DOT Selfie: A Mobile Technology Intervention to Evaluate Treatment Adherence Among Tuberculosis Patients
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      This is a randomized controlled trial (RCT) to determine whether Video Observed Treatment
      (VDOT) using social internet bundle incentives for tuberculosis (TB) is an effective way to
      improve medication adherence in TB treatment, compared with standard in-person treatment
      (home-/ community-based).

      The study will include two study arms: one will receive TB treatment using the standard
      in-person DOT, and the other through VDOT. All patients (regardless of study arm) will
      receive daily TB treatment under home- or community-based observation . For patients in the
      In-person DOT arm, this will be observed and recorded daily by a study nurse. Patients in the
      VDOT arm however, will be required to record and upload their daily medication intake using a
      mobile phone App. As a form of incentive, these patients will be rewarded with social
      internet bundles for every 7 consecutive video uploads. Additionally, they will be sent
      motivational text messages to encourage treatment compliance.

      Regardless of study arm, all patients will have 2,4, and 6 monthly clinic visits for clinical
      and/or sputum assessments. Each patient will also complete a Morisky Medication Adherence
      Scale (MMAS) questionnaire at treatment completion.
    

Detailed description: 
      Eligible patients will be randomised in equal proportions between the DOT Selfie Intervention
      and In-person DOT Control arms. All patients will self-administer TB drugs daily for 6
      months, or as prescribed by their physician. Once recruited, all patients will receive
      routine education on TB treatment, side-effects and the importance of adherence. They will
      also receive a baseline survey to collect data on demographics, personal, social and clinical
      characteristics, cell phone/smartphone ownership and prior experience with use of video
      camera features. Patients will be informed that regardless of the intervention allocation,
      they will be required to return to the clinic for study follow up at 2, 4 and 6 months to
      complete a follow-up interview with study staff (clinical and/ or sputum assessments).

      DOT Selfie Intervention Arm. The DOT Selfie Intervention will comprise a smart phone, the
      VDOT App, a prepaid weekly internet bundle and text message medication reminders. The smart
      phone will be equipped with a camera that supports video recording. Additionally, it will
      have internet access, and an operating system capable of running downloaded applications. The
      VDOT App is a free, downloadable, passcode-protected mobile App provided by SureAdhere. It is
      equipped with video recording features and automatic, encrypted, time-stamped video uploads
      to a secure server. This enables patients to securely and confidentially document each
      medication dose taken. The VDOT system has a feature to adapt and personalize text messages
      either in English or Luganda. These text messages will include reminders for patients to take
      their medications, lists of common medication side effects and motivational messages to
      encourage patients to continue taking their medications and report any side effects.

      Upon assignment to VDOT intervention arm, patients will receive detailed training (in English
      or Luganda) on VDOT use, using a detailed training manual provided by SureAdhere. Patients
      will also be trained on how to lay out each drug on a labelled laminated medication sheet
      with a space for each drug and take each drug type individually saying either the name of the
      drug or the color of the pills, size, and the number taken. Participants will be asked to
      show their mouth is empty by opening their mouth and sticking out their tongue and finally be
      asked to report any symptoms from a list of key side effects (which will be printed on the
      reverse of the laminated medication sheet - Appendix j). Any reported or observed side
      effects will be addressed by study nurses as indicated in Appendix k. Training will include
      watching of some test videos.

      Once training is complete, the study will then begin with patients receiving the intervention
      (smart phone, the VDOT App, prepaid weekly internet bundle and text message medications
      reminders). Each patient will be required to record and submit daily videos as they
      self-administer their medication, when and where it works best for them. For each patient,
      Day 1 of the study will the mark the day the first dose of TB drugs was self-administered.
      Patients who successfully submit their videos for seven consecutive days will receive a
      weekly incentive in the form of social bundles of airtime minutes. Patients will be
      encouraged to try and maintain full compliance with daily drug regimen through personalized
      text message reminders such as "Taking your pills will help you get better and keep you from
      infecting family and friends." They will also be encouraged to report side effects and other
      related concerns through the VDOT system.

      VDOT videos recorded by patients using the SureAdhere App, will be uploaded to 99DOT, a
      secure server and HIPAA compliant web portal used to review and track patients medication
      intake videos. These videos will be submitted automatically as soon as the phone is connected
      to a cellular data network (data plan provided with phone) or wireless network. At the
      clinic, a trained study nurse will log into the 99DOTs secured system via a tablet or laptop
      to download, review the patients' daily videos and document adherence according to a
      pre-specified protocol for VDOT. The nurse will view the date and time stamped videos on
      99DOT, to document each medication dose taken. The nurse will thus be able to track missed
      videos, reported side-effects and follow-up with appropriate support advice to patients using
      actions specified in the study protocol. The nurse will log the time taken to contact the
      patient by phone, text, or in person to manage adherence problems or address any issues. VDOT
      videos will be read by a study nurse/VDOT observer daily during weekdays with weekend videos
      read on Mondays.

      No incentives or travel costs will be provided but patients will be able to make use of study
      smartphone for e-mails, domestic telephone calls and internet searches (limited data
      downloads apply). Patients will be expected to return the smartphone to the clinic upon
      completion of their treatment.

      In-person DOT Control Arm:

      Patients in this arm will be managed according to usual clinical practice in Uganda. This
      will require prior arrangements to be made between the study nurse(s) and each patient, for a
      convenient meeting place (e.g. at the patient's work, home etc.) to be agreed upon. The study
      nurse will then be required to meet the patient daily at this location. At each daily
      meeting, the study nurse will provide the prescribed medication and the patient will swallow
      each TB medication as the study nurse directly observes and documents (date, time, drug
      dosing etc.) For each patient, Day 1 of the study will the mark the day the first dose of TB
      drugs was self-administered. Patients will be encouraged by the study nurse to report any
      side effects experienced, or any other related concerns. The study nurse will also encourage
      patients to maintain full compliance, by continuing to meet daily to have the nurse directly
      observe their self-administration of the drug. At the end of each meeting, the patient and
      nurse will agree on a convenient meeting place for the next day's dosing. The study nurse
      will record all of these and follow-up with appropriate support advice to manage adherence
      problems or other issues, using actions specified in the study protocol. The nurse will also
      log the time taken to reach the patient, amount of money spent on round-trip transportation,
      and total amount of time spent during each patient encounter.
    

Intervention name(s): DOT Selfie Intervention; In-person DOT
Intervention type(s): Device; Other
Intervention description(s): This comprises a smart phone, the VDOT App, a prepaid weekly internet bundle and text message medication reminders; Directly observed TB treatment by a health-worker either in a patient's home or at an agreed upon location within the community.
Other intervention name(s): VDOT (Video Observed Treatment); Standard DOT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an open-label parallel pilot RCT where adult male and female patients with a new diagnosis of TB (N=144) will be randomized to DOT selfie (n=72) and standard in-person DOT (n=72). Patients in the DOT selfie arm will receive the intervention, which will comprise a smart phone, the VDOT App, a prepaid weekly internet bundle and text message medication reminders. Patients receiving sin-person DOT will serve as the control arm.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Tuberculosis,; Video Directly Observed Treatment; Directly Observed Treatment; Uganda; Treatment adherence; mHealth