Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis

NCT01960257 | Completed Phase 4 Results

• 1 other identifier: AHF TB 001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tuberculosis

Keywords

tuberculosis; tuberculosis treatment; wirelessly observed therapy; proteus digital health; digital health feedback system

Outcome Measures

Primary Outcomes (2)

• Step 1: Positive Detection Accuracy (PDA)

  Determine positive detection accuracy (PDA, direct confirmation of TB medication ingestion) of the DHFS when compared to a healthcare worker witnessing actual TB medication ingestion.

  2 weeks

• Step 2: Percentage of Witnessed Doses

  Determine the percentage of witnessed doses by DHFS and standard of care (SOC), respectively.

  16 weeks

Secondary Outcomes (1)

• Characterize Subject Responses to Post-study Questionnaires to Collect Information Regarding Their Experience With the DHFS Using Summary Statistics.

  2-3 weeks

Study Arms (2)

DHFS with IS-RM

EXPERIMENTAL

Digital Health Feedback System (DHFS) Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) over-encapsulated with ingestion sensor - 2 capsules orally daily (QD) administered orally preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.

Device: Digital Health Feedback System

SOC DOT

ACTIVE COMPARATOR

Isoniazid 300 mg -1 tablet orally QD plus rifampin 300 mg - 2 capsules orally QD, OR Rifamate (combination of isoniazid 150 mg and rifampin 300 mg) - 2 capsules orally QD preferably on an empty stomach first thing in the morning for 10-16 weeks, depending on time left to complete TB treatment.

Other: SOC DOT

Interventions

Digital Health Feedback System DEVICE

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.

Also known as: DHFS

DHFS with IS-RM

SOC DOT OTHER

SOC DOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Department of Health and Human Services: collaborator
• Proteus Digital Health, Inc.: collaborator

Study Sites (2)

UCSD AntiViral Research Center

San Diego, California, 92103, United States

Location

San Diego County Public Health Services

San Diego, California, 92110, United States

Location

Related Publications (1)

• Browne SH, Umlauf A, Tucker AJ, Low J, Moser K, Gonzalez Garcia J, Peloquin CA, Blaschke T, Vaida F, Benson CA. Wirelessly observed therapy compared to directly observed therapy to confirm and support tuberculosis treatment adherence: A randomized controlled trial. PLoS Med. 2019 Oct 4;16(10):e1002891. doi: 10.1371/journal.pmed.1002891. eCollection 2019 Oct.

  PMID: 31584944 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dr. Sara H. Browne
• Organization: University of California, San Diego

shbrowne@health.ucsd.edu

619 543 8080

Study Officials

• Sara Browne, MD, MPH

  University of California, San Diego

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Research Associate

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: October 25, 2013
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: May 12, 2021
• Results First Posted: May 12, 2021

Record last verified: 2021-05

Locations

US (2)