An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment

Completed · Not applicable

Conditions studied: Tuberculosis, Drug-resistant Tuberculosis, Adherence, Medication, Adherence, Patient

In brief

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.

Key facts

Study ID

NCT03266003

Run by

Centers for Disease Control and Prevention

People needed

216

Starts

2017-07-19

Expected to finish

2020-12-31

Last updated by the study team

2026-07-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fort Greene Chest Center — Brooklyn, New York, United States
• Corona Chest Center — Jackson Heights, New York, United States
• Washington Heights Chest Center — New York, New York, United States
• Morrisania Chest Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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