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N/A N=10,644 Randomized Diagnostic

GeneXpert Performance Evaluation for Linkage to Tuberculosis Care

Tuberculosis, Pulmonary · Rifampicin Resistant Tuberculosis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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