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Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis

RecruitingNA

Sponsor: University of California, San Francisco

Conditions: Drug-resistant Tuberculosis, HIV Coinfection, Cost-Benefit Analysis

Interventions: Targeted next-generation sequencing

Countries: South Africa

TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Active RR-TB diagnosed at a study facility during the study period
2. Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract)

Exclusion Criteria:

1. Patient expects to relocate/move residence outside of the study region
2. Patient does not agree to participate in the study

In addition, participants later found to have isolates with rifamycin susceptibility on at least two additional tests (e.g., phenotypic DST, LPA, or sequencing) will be considered late exclusions.

Locations (1)

Cape Town, South Africa