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:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT03044158
Eligibility Criteria:
Inclusion Criteria:
* Site-level: Use standard (multi-day) sputum smear microscopy as the primary method of TB diagnosis
* Site-level: Participate in NTP-sponsored external quality assurance (EQA) for sputum smear microscopy
* Site-level: Send samples to a district or regional hospital/health center for Xpert testing
* Patient-level: Initiate evaluation for active TB at a study health center
Exclusion Criteria:
* Site-level: Do not agree to be randomized to standard-of-care vs. intervention arms
* Site-level: Perform sputum smear examination on \<150 patients per year (based on 2015 data)
* Site-level: Diagnose \<15 smear-positive TB cases per year (based on 2015 data)
* Patient-level: Have sputum collected for monitoring of response to anti-TB therapy
* Patient-level: Have sputum collected as part of active, community-based case finding (e.g., contact tracing, community outreach campaign)
* Patient-level: Referred to a study health center for TB treatment after a diagnosis is established elsewhere
* Patient-level: Started on TB treatment for extra-pulmonary TB only
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03044158
Study Brief:
Protocol Section:
NCT03044158