N/A
N=10,644
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
Tuberculosis, Pulmonary · Rifampicin Resistant Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT03044158 ↗Enrolled (actual)
10,644
Serious AEs
—
Results posted
Feb 2025
Primary outcome: Primary: Number Treated for Microbiologically-confirmed TB Within 14 Days After Presentation to the Health Center for TB Evaluation — 220; 342 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GeneXpert I (Device); Process re-design (Behavioral); Performance Feedback (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Treated for Microbiologically-confirmed TB Within 14 Days After Presentation to the Health Center for TB Evaluation |
220; 342 | — |
| SECONDARY Number Diagnosed With Microbiologically-confirmed TB |
299; 389 | — |
| SECONDARY Time to Microbiologically-confirmed TB |
0; 0 | — |
| SECONDARY Number Treated for TB |
339; 485 | — |
| SECONDARY Time-to-treatment of Microbiologically-confirmed TB |
1; 0 | — |
| SECONDARY Number Who Died Within 6 Months |
123; 116 | — |
| SECONDARY Number of Patients Enrolled |
5098; 5546 | — |
| SECONDARY Number Tested for TB According to National Guidelines |
2687; 5108 | — |
| SECONDARY Number Suspected/Diagnosed With Rifampin-resistant TB |
5; 2 | — |
| SECONDARY Number Diagnosed and Treated for Microbiologically-confirmed TB |
106; 251 | — |
| SECONDARY Number Diagnosed AND Treated for TB |
199; 362 | — |
Summary
The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing. The intervention strategy was developed based on theory-informed assessment of barriers to TB diagnostic evaluation at community health centers in Uganda and a process of engagement with local stakeholders. It includes: 1) Point-of-care molecular testing using GeneXpert as a replacement for sputum smear microscopy; 2) Re-structuring of clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3) Quarterly feedback of TB evaluation metrics to health center staff. The investigators' central hypothesis is that the intervention strategy will have high uptake and increase the number of patients diagnosed with and treated for active pulmonary TB. To test this hypothesis, the investigators will conduct a pragmatic cluster-randomized trial at community health centers that provide TB microscopy services in Uganda in partnership with the National TB Program (NTP). The investigators utilize an effectiveness-implementation hybrid design in which, concurrent with the clinical trial, the investigators will conduct nested mixed methods, health economic and modeling studies to assess 1) whether the intervention strategy modifies targeted barriers to TB diagnostic evaluation; 2) fidelity of implementation of the intervention components (i.e, the degree to which intervention components were implemented as intended vs. adapted across sites); and 3) cost-effectiveness and public health impact.
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
Data sourced from ClinicalTrials.gov (NCT03044158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.