Evaluating new point-of-care tests for tuberculosis diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ADAPT initiative aims to assess innovative point-of-care diagnostic tests for tuberculosis (TB) to improve detection rates in high-burden countries. By focusing on non-sputum biomarker-based tests, the study seeks to bridge the diagnostic gap that leaves many TB cases undiagnosed. Participants will include adolescents and adults with symptoms or risk factors for TB, and the tests will be evaluated against established standards like sputum Xpert® and culture methods. Usability and acceptability of these tests will also be measured through health worker observations and surveys.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Adithya Cattamanchi — University of California, Irvine
• Study coordinator: Adithya Cattamanchi
• Email: adithya.cattamanchi@ucsf.edu
• Phone: +1-415-206-5489

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.