GeneXpert Performance Evaluation for Linkage to Tuberculosis Care

• Register: ClinicalTrials.gov
• Last refreshed on: 1 May 2023
• Main ID: NCT03044158
• Date of registration: 23/01/2017
• Prospective Registration: Yes
• Primary sponsor: University of California, San Francisco
• Public title: GeneXpert Performance Evaluation for Linkage to Tuberculosis Care XPEL-TB
• Scientific title: GeneXpert Performance Evaluation for Linkage to Tuberculosis Care: The XPEL-TB Trial
• Date of first enrolment: October 22, 2018
• Target sample size: 10644
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03044158
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Uganda

Contacts

• Name: Adithya Cattamanchi, MD
• Affiliation: University of California, San Francisco

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis, Pulmonary

Rifampicin Resistant Tuberculosis

Intervention(s)

Behavioral: Process re-design

Other: Performance Feedback

Device: GeneXpert I

Primary Outcome(s)

Number treated for microbiologically-confirmed TB within two weeks of referral for sputum-based testing [Time Frame: Within 2 weeks of initial sputum submission]

Secondary Outcome(s)

Number referred for TB testing [Time Frame: Within 2 weeks of initial sputum submission]

Number who died within 6 months [Time Frame: Days from initial health center visit to treatment outcome, up to 6 months.]

Number diagnosed AND completing treatment [Time Frame: Days from initial health center visit to treatment outcome, up to 2 years.]

Number suspected/diagnosed with RIF-resistant TB [Time Frame: Within 2 weeks of initial sputum submission]

Number treated for TB [Time Frame: Within 2 weeks of initial sputum submission]

Number of patients enrolled [Time Frame: Within 2 weeks of initial sputum submission]

Time-to-treatment of microbiologically-confirmed TB [Time Frame: Days from initial health center visit to initiation of treatment if diagnosed, up to 1 year.]

Time to microbiologically-confirmed TB [Time Frame: Days from initial sputum submission to being diagnosed, up to 60 days.]

Number diagnosed with microbiologically-confirmed TB [Time Frame: Within 2 weeks of initial sputum submission]

Number diagnosed and treated for microbiologically-confirmed TB [Time Frame: Within 2 weeks of initial sputum submission]

Secondary ID(s)

R01HL130192

PACTR201610001763265

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Yale University

Makerere University

London School of Hygiene and Tropical Medicine

Johns Hopkins Bloomberg School of Public Health

National Heart, Lung, and Blood Institute (NHLBI)