Status:
COMPLETED
An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
New York City Department of Health and Mental Hygiene
Columbia University
Conditions:
Tuberculosis
Drug-resistant Tuberculosis
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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 Ini...
Detailed 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 t...
Eligibility Criteria
Inclusion
- Individuals must meet the following inclusion criteria in order to participate in this study:
- All TB patients (both those with a confirmed diagnosis and those with a clinical diagnosis), started on treatment for non-rifamycin resistant TB, and eligible to receive DOT.
- Physician determines the patient may be treated with any treatment regimen for non-rifamycin resistant TB approved by the NYC DOHMH TB program.
- Individuals found to have Isoniazid (INH) resistant disease are eligible for inclusion.
- Age \>18 years or older
- Age 12 to 17 years, with the consent of a parent or legal guardian
- An address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.
- No plans to move out of the catchment areas of the participating TB program sites within 9 months of enrollment.
- Willingness to comply with study procedures and provide written informed consent prior to study enrollment.
- Individuals for whom a diagnosis of TB has been made clinically are eligible for study inclusion. Data may be collected from these patients related to all objectives with the exception of culture conversion.
Exclusion
- An individual meeting any of the following exclusion criteria at the time of enrollment will be excluded from study participation:
- At the time of enrollment, the patient's Mtb isolate is already known to be resistant to rifamycin or prescribed a non-rifamycin treatment regimen.
- Prescribed any injectable, anti-TB medication as part of an outpatient treatment regimen.
- Adverse reaction to initial doses of anti-TB medication (per NYC protocol) of sufficient severity that in the judgement of the clinician makes study participation not in the individual's best interest.
- A cognitive or physical disability that prevents full participation in eDOT (e.g., vision, hearing, physically challenged, inability to swallow medications). Note: Exceptions will be made for those patients who crush pills in order to swallow the medication, or have a member of their household or a caregiver who can assist them for the duration of the study.
- Less than 12 years of age.
- Patients 12-17 years of age, whose parents or legal guardians refuse to provide consent.
- Incarceration, institutionalization, or other involuntary detention.
- Plans to move out of the catchment areas of the participating TB program sites in less than 9 months from the day of enrollment.
- Previously enrolled in this study.
- Currently enrolled in a clinical trial that prohibits enrollment in another study.
- Other medical conditions that, in the investigator's or the clinic physician's judgment, make study participation not in the individual's best interest.
Key Trial Info
Start Date :
July 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03266003
Start Date
July 19 2017
End Date
December 31 2020
Last Update
July 28 2021
Active Locations (4)
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1
Fort Greene Chest Center
Brooklyn, New York, United States, 11201
2
Corona Chest Center
Jackson Heights, New York, United States, 11372
3
Washington Heights Chest Center
New York, New York, United States, 10032
4
Morrisania Chest Center
The Bronx, New York, United States, 10456