Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: Digital Health Feedback System; SOC DOT
Intervention description: This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications.
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tuberculosis; tuberculosis treatment; wirelessly observed therapy; proteus digital health; digital health feedback system

Summary:

      This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin),
      which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect
      information about patients taking their TB medications. The wearable sensor records
      information, which is uploaded wirelessly to a mobile device and then to a secure computer.
      Together the sensors and the mobile device transmitting the information to the study computer
      are called a digital health feedback system (DHFS), which gives healthcare providers
      information about when patients have taken their TB medications. The advantage of the DHFS is
      that patients can take their medication where and when it is convenient for them, and do not
      have to wait for a nurse to directly observe them taking their medication.

      The purpose of this study is to find out if using these new technologies works as well as the
      standard method of observing in person when patients take their TB medications. This study
      will also look at the costs of using a DHFS for TB medications, what patients and healthcare
      providers think about using it, and other factors that can determine when one approach works
      better than another.

      This study has two parts. For the first part of the study (Step I), patients will have an
      initial screening visit and then, in one two-week period, they will have 4 study visits at
      the UCSD AntiViral Research Center (AVRC) and routine visits from Public Health Services
      (PHS) workers. This part of the study is designed to confirm that the DHFS is working
      correctly and is accurately collecting information about each dose of medication that
      patients take, and to understand what patients and healthcare providers think about using the
      DHFS.

      If patients are eligible for the second part of the study (Step II) and want to continue,
      that will last another 8-14 weeks with an additional 4 study visits at the AVRC. In the
      second part of the study, patients will be randomized into one of the following two groups.

      Group 1: TB treatment is monitored by continued use of the DHFS

      Group 2: TB treatment is monitored by the standard methods used by PHS (DOT)

      The second part of the study is designed to compare these two methods of observing patients
      taking their TB medications, what the relative costs of these methods are , and the
      perception by patients and/or healthcare providers of the ease of use of the novel
      technology.
    

Eligibility criteria:

        Inclusion Criteria

          -  Basic competency in understanding written and verbal information as it applies to DHFS
             use.

          -  Persons undergoing treatment for TB that includes at least isoniazid and rifampin at
             the time of entry to Phase 1; of note, patients must be sputum smear negative at the
             time of study entry.

          -  Laboratory values obtained by screening laboratories within 30 days of entry:

               -  Absolute neutrophil count (ANC) >= 1,000/mm3.

               -  Hemoglobin >= 9.0 g/dL.

               -  Platelet count >= 75,000/mm3.

               -  AST (SGOT), ALT (SGPT), and alkaline phosphatase <= 3 x ULN.

               -  Total bilirubin <= 1.5 x ULN and direct bilirubin.

          -  Females of childbearing potential must agree to use contraception throughout the study
             period.

          -  Men and women age >= 18 years.

          -  Eligible for anti-mycobacterial medications and in possession of prescriptions for
             isoniazid and rifampin, or Rifamate, as appropriate.

          -  Willing to follow all protocol requirements.

          -  Ability to use mobile device per investigator determination, and to wear PDH wearable
             sensor (i.e., no skin conditions precluding use).

          -  Ability and willingness of subjects to give written informed consent.

        Exclusion Criteria

          -  Female who is pregnant or breast-feeding, or of childbearing potential and has a
             tuberculin positive test at screening and disagrees to use contraception throughout
             the study period.

          -  Use of any of the prohibited medications or other non-informed medications within 30
             days of study entry.

          -  Known hypersensitivity to any of the study drugs.

          -  Known sensitivity to skin adhesives.

          -  Serious illness requiring systemic treatment and/or hospitalization until subject
             either completes therapy or is clinically stable on therapy, in the opinion of the
             investigator, for at least 30 days prior to study entry (Day 0).

          -  Evidence of any anti-mycobacterial resistance, clinical or genetic, prior to study
             entry. Resistance testing results must be available for review by the site
             investigator and study protocol team prior to enrollment to ensure that no
             exclusionary resistance exists.

          -  Active drug or alcohol use, or dependence, or other conditions that, in the opinion of
             the site investigator, would interfere with adherence to study requirements.