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Assessing Diagnostics At Point-of-care for Tuberculosis

RecruitingNAAges 12 Years - anyAllUniversity of California, San Francisco
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Novel TB triage and diagnostic tests: Inclusion Criteria- The investigators will include non-hospitalized adults (age โ‰ฅ 12 years) with either: 1. cough โ‰ฅ2 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 2. 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: 1. People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) \>5 mg/dL OR abnormal chest x-ray (CXR) 2. Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR Exclusion Criteria- 1. Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively); 2. Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives); 3. Reside \>20km from the study site or are unwilling to return for follow-up visits; OR 4. 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: 1. aged โ‰ฅ18 years; AND 2. 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
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What it tests

  • Tongue swab-based molecular assays
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Where

3 sites
Zankli Research Center, Bingham University
Abuja, Nigeria
De La Salle Medical and Health Sciences Institute
Dasmariรฑas, Philippines
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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