Assessing Diagnostics At Point-of-care for Tuberculosis
Supporting, Mobilizing and Accelerating Research for Tuberculosis Elimination (SMART4TB)- Technical Area (TA) 1: Diagnostics- Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)
University of California, San Francisco
1,350 participants
Aug 28, 2023
INTERVENTIONAL
Conditions
Summary
Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests.
Eligibility
Inclusion Criteria10
- Novel TB triage and diagnostic tests:
- The investigators will include non-hospitalized adults (age ≥ 12 years) with either:
- cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups; OR
- risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:
- Positive TB screening definitions by risk factor:
- People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) >5 mg/dL OR abnormal chest x-ray (CXR)
- Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR
- The investigators will include health workers at each clinical site who are:
- aged ≥18 years; AND
- involved in routine TB testing (collecting specimens for or performing TB tests).
Exclusion Criteria7
- Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
- Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
- Reside >20km from the study site or are unwilling to return for follow-up visits; OR
- Are unwilling to provide informed consent
- Assessment of the usability of novel TB tests:
- The investigators will exclude staff who are:
- \) unwilling to provide informed consent
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The investigators will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05941052