GeneXpert Performance Evaluation for Linkage to Tuberculosis Care

Not Applicable

• Conditions: Tuberculosis

• Registration Number: PACTR201610001763265
• Lead Sponsor: niversity of California San Francisco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 5500

Inclusion Criteria

1. (Site-level) Use standard (multi-day) sputum smear microscopy as the primary method of TB diagnosis
2. (Site-level) Participate in NTP-sponsored external quality assurance (EQA) for sputum smear microscopy
3. (Site-level) Send samples to a district or regional hospital/health center for Xpert testing
4. (Patient-level) Initiate evaluation for active TB at a study health center

Exclusion Criteria

1. (Site-level) Do not agree to be randomized to standard-of-care vs. intervention arms
2. (Site-level) Perform sputum smear examination on <150 patients per year (based on 2015 data)
3. (Site-level) Diagnose <15 smear-positive TB cases per year (based on 2015 data)
4. (Patient-level) Have sputum collected for monitoring of response to anti-TB therapy
5. (Patient-level) Have sputum collected as part of active, community-based case finding (e.g., contact tracing, community outreach campaign)
6. (Patient-level) Referred to a study health center for TB treatment after a diagnosis is established elsewhere
7. (Patient-level) Started on TB treatment for extra-pulmonary TB only

Study & Design

• Study Type: Interventional
• Study Design: Not specified