Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT03266003
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03266003
Study Brief:
Protocol Section:
NCT03266003