N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Not applicable ClinicalTrials.gov

Assessing Diagnostics At Point-of-care for Tuberculosis

Sponsor: University of California, San Francisco • ClinicalTrials.gov ID: NCT05941052

Registry updated: 2026-09-02
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Tongue swab-based molecular assays (Diagnostic test)
    The investigators will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.

Eligibility criteria

Novel TB triage and diagnostic tests: Inclusion Criteria- The investigators will include non-hospitalized adults (age ≥ 12 years) with either: 1. 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 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 ≥18 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

Conditions

Tuberculosis

Locations

  • Zankli Research Center, Bingham University — Abuja, Nigeria
  • De La Salle Medical and Health Sciences Institute — Dasmariñas, Philippines
  • Centre for Infectious Disease Research in Zambia — Lusaka, Zambia
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record