At a glance
ClinicalIndex Comparison RecordN/ACompleted· 776 enrolled
Drug / intervention
Xpertdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Z 31411 - The Effect of Xpert MTB/RIF on Patient Health Outcomes and Empirical TB Treatment Among Persons Living With HIV/AIDS: A Parallel-Group Prospective Cohort Study Under Real-World Conditions in Lusaka, Zambia
In Brief
An observational study evaluating Xpert for Tuberculosis. Completed, enrolled 776 participants across 1 site.
Detailed Summary
A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to TB diagnosis and TB treatment; 3) presumptive TB patient drop-out from the TB diagnostic "cascade" before starting TB treatment; and 4) loss to follow-up after initiation of TB treatment.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesZambia
CollaboratorsNational Institutes of Health (NIH)
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionFeb 2018
TodayJul 2026
First PostedApr 6, 2016
Enrollment StartJun 22, 2016
Primary CompletionFeb 9, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.2 years ago
Interventions
Xpertdevice
The Xpert MTB/RIF assay is a nucleic acid amplification (NAA) test that uses a disposable cartridge with the GeneXpert Instrument System