Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03266003 |
Other study ID # |
CDC-6995.0 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 19, 2017 |
Est. completion date |
December 31, 2020 |
Study information
Verified date |
July 2021 |
Source |
Centers for Disease Control and Prevention |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial
(with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic
Resistance Solutions Initiative) that will be implemented to evaluate traditional directly
observed therapy (DOT) and electronic forms of DOT (eDOT) for tuberculosis (TB) treatment.
The trial will assess whether eDOT that employs electronic communication methods, such as
video via computer or cellphone, is a non-inferior approach to monitor TB treatment
adherence, compared to traditional in-person DOT (ipDOT), in which a trained person is in the
physical presence of patients as anti-TB drugs are ingested. ipDOT is the single best
intervention proven to be successful when it comes to TB patients' adherence to therapy
(which reduces risk of acquired drug resistance). However, ipDOT is resource intensive and
many times challenging to facilitate in-person. If eDOT is found to be non-inferior to ipDOT,
health departments and other clinicians might be able to provide eDOT to certain populations
of TB patients in a more flexible and potentially cost-saving manner.
Description:
Tuberculosis (TB) is among the most common infectious diseases and cause of death worldwide.
The bacteria that causes TB, Mycobacterium tuberculosis (Mtb), is spread when a person with
TB disease of the lungs or throat coughs, speaks, or sings. These bacteria can float in the
air for several hours, depending on the environment. Persons who breathe in the air
containing these TB bacteria can become infected.
The World Health Organization (WHO) estimates that 9.6 million became ill with TB in 2014.
Among this group, approximately 480,000 persons became ill with multidrug-resistant TB (MDR
TB), which is TB caused by bacteria that are resistant to at least isoniazid and rifampin,
the two most potent TB drugs used to treat persons with TB disease. Extensively drug
resistant (XDR) strains of TB were reported by 105 countries in 2015. As such, the National
Strategy for Combatting Antibiotic Resistant Bacteria (CARB) has designated Mtb a SERIOUS
threat level pathogen.
Completion of treatment by persons with TB disease represents the optimal path to the
prevention of morbidity and mortality, cure of the patient, interruption of transmission, and
prevention of acquired drug resistance. The single best intervention in this regard has
proven to be directly observed therapy (DOT).
DOT provides frequent interactions between the patient and the patient's healthcare team.
This enables better monitoring and efficient response to medication side effects. This is
especially important as medication side effects are among the top reasons patients are lost
to follow-up during treatment therapy.
Experience in the U.S. in the 1990s demonstrated the efficacy of this intervention in the
prevention and control of drug-resistant tuberculosis.Studies in the past 15 years in
international settings have challenged the utility of DOT, but have been criticized for
imperfect to poor design or implementation.
DOT entails a trained "observer" acceptable to both the patient and the health system being
present to monitor treatment adherence as patients swallow anti-TB drugs. In the United
States, DOT remains a cornerstone of TB control. While DOT represents the treatment standard,
the implementation of DOT has been modified by some programs in an effort to reduce costs and
conserve program resources. In the U.S., efforts recently have sought to utilize advances in
communication technology to facilitate the implementation of DOT.
This study will evaluate traditional approaches to DOT compared to DOT by electronic methods.
The study will be based within, and primarily conducted by the New York City Department of
Health and Mental Hygiene (NYC DOHMH), Bureau of Tuberculosis Control (BTBC) clinics. This
will enable the study to be to be conducted in a programmatic setting and reflect "real-life"
situations.
Hypothesis: Directly observed therapy (DOT) that employs electronic communication methods
(eDOT) is a non-inferior approach to monitor treatment adherence, compared to traditional
forms of DOT, in which a trained person is in the physical presence of patients as anti-TB
drugs are ingested (ipDOT).
Design: This will be a U.S.-based, 1 site (with 4 clinic settings), randomized, cross-over,
2-arm, non-inferiority trial with randomization to either traditional in-person DOT (ipDOT)
or electronic DOT (eDOT)*, at the time outpatient treatment begins within participating
health department clinics.
*Secondary analyses will evaluate DOT conducted in "real time" or "live" (eDOT-live) compared
to DOT that uses a recorded video (eDOT-recorded).
Population:Patients newly diagnosed with drug-sensitive or non-rifamycin resistant TB.
Site: Four clinics of the New York City Department of Health and Mental Hygiene, Bureau of
Tuberculosis Control.
Study Duration: Duration per participant is approximately 6 months.
Description of Intervention: After providing written informed consent, participants will be
randomly assigned to one of the following DOT study group assignments: (1) traditional
in-person DOT (ipDOT) or (2) electronic DOT (eDOT).
Note: Patients and their providers will discuss and choose the type of eDOT they will use.
The two options are: (2a) eDOT conducted "live" in which TB program staff interact with
patients in real-time via a computer or phone application as they ingest their medication
(eDOT-live), and (2b) eDOT in which patients record themselves ingesting their TB medication
using "time-stamped, recorded" videos for TB program staff to review within 1 business day
(24 hours), and verify that patients ingested their medication doses as scheduled
(eDOT-recorded).
Following 20 observable medication doses under an initial DOT study group assignment
participants will be assigned (crossed-over) to the opposite DOT method to collect data on
another 20 observable medication doses. Specifically, participants who initially received
ipDOT will switch to eDOT. Participants initially assigned to eDOT will switch to ipDOT.
At the conclusion of this Cross-Over Period with 40 observable medication doses, participants
will continue treatment using their preferred DOT method.