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NCT03266003

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

Sponsor: Centers for Disease Control and Prevention

View on ClinicalTrials.gov

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.

Official title: An Evaluation of Traditional Directly Observed Therapy and Electronic Forms of Directly Observed Therapy for Tuberculosis Treatment

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2017-07-19

Completion Date

2020-12-31

Last Updated

2026-07-02

Healthy Volunteers

Conditions

Tuberculosis Drug-resistant Tuberculosis Adherence, Medication Adherence, Patient

Interventions

OTHER

Electronic DOT

Electronic DOT is the use of electronic communication methods to observe patients swallow anti-TB drugs and monitor for medication side effects. This study will use two variations of electronic communication methods, referred to as "electronic directly observed therapy" or "eDOT". This includes: (1) eDOT conducted "live" in which TB program staff interact with patients via a computer or phone application as they ingest their medication (eDOT-live), and (2) eDOT conducted using "time stamped, recorded" videos in which TB program staff log into an electronic system and review videos recorded by patients in order to verify that patients ingested their medication doses as scheduled (eDOT-recorded).

OTHER

In-person DOT

A trained person is in the physical presence of patients as anti-TB drugs are ingested.

Inclusion Criteria: Individuals must meet the following inclusion criteria in order to participate in this study: 1. 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. 2. Physician determines the patient may be treated with any treatment regimen for non-rifamycin resistant TB approved by the NYC DOHMH TB program. 3. Individuals found to have Isoniazid (INH) resistant disease are eligible for inclusion. 4. Age \>18 years or older 5. Age 12 to 17 years, with the consent of a parent or legal guardian 6. 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. 7. No plans to move out of the catchment areas of the participating TB program sites within 9 months of enrollment. 8. Willingness to comply with study procedures and provide written informed consent prior to study enrollment. 9. 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 Criteria: An individual meeting any of the following exclusion criteria at the time of enrollment will be excluded from study participation: 1. 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. 2. Prescribed any injectable, anti-TB medication as part of an outpatient treatment regimen. 3. 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. 4. 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. 5. Less than 12 years of age. 6. Patients 12-17 years of age, whose parents or legal guardians refuse to provide consent. 7. Incarceration, institutionalization, or other involuntary detention. 8. Plans to move out of the catchment areas of the participating TB program sites in less than 9 months from the day of enrollment. 9. Previously enrolled in this study. 10. Currently enrolled in a clinical trial that prohibits enrollment in another study. 11. Other medical conditions that, in the investigator's or the clinic physician's judgment, make study participation not in the individual's best interest.

Locations (4)

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