Phase
Condition
Lung Disease
Hiv
Treatment
Tongue swab-based molecular assays
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Novel TB triage and diagnostic tests:
Inclusion Criteria-
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
Exclusion Criteria-
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:
Inclusion Criteria-
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 Criteria-
The investigators will exclude staff who are:
- unwilling to provide informed consent
Study Design
Study Description
Connect with a study center
Zankli Research Center, Bingham University
Abuja,
NigeriaActive - Recruiting
De La Salle Medical and Health Sciences Institute
Dasmariñas,
PhilippinesActive - Recruiting
Centre for Infectious Disease Research in Zambia
Lusaka,
ZambiaActive - Recruiting
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