Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)
Tuberculosis
About this trial
This is an interventional diagnostic trial for Tuberculosis focused on measuring Tuberculosis, Diagnostics, Global Health
Eligibility Criteria
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: 1) unwilling to provide informed consent
Sites / Locations
- Zankli Research Center, Bingham UniversityRecruiting
- De La Salle Medical and Health Sciences InstituteRecruiting
- Centre for Infectious Disease Research in ZambiaRecruiting
Arms of the Study
Arm 1
Experimental
Evaluation of various novel TB triage and diagnostic tests
For the novel TB triage and diagnostic tests, the investigators will conduct large-scale evaluation of design-locked tests in a cohort of adults with presumed TB. The investigators aim to enroll 450 participants per year at each of three enrollment sites for evaluation of various novel TB triage and diagnostic tests and 50 health workers to assess test usability.