Testing New Ways to Diagnose Tuberculosis More Quickly and Simply
Tests new tuberculosis diagnostic methods in people aged 12 and older.
Plain-language title generated from the registry record
Registry title: Rapid Research in Diagnostics Development for TB Network
Key facts
- Where
- Lusaka, ZambiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for non-hospitalized people aged 12 or older with a long cough or a risk factor for TB, and adults with TB resistant to rifampicin (RIF). Health workers who do TB testing can also join the usability part.
- Age
- 12 years or older for the test studies; 18 years or older for health workers.
- Sex
- All
- Disease stage
- Cough lasting 2 weeks or more, or a TB risk factor (HIV infection, close contact with someone with TB, history of mining work) with a positive TB screen. For the drug-resistance part: TB and RIF resistance found on routine testing.
- Earlier treatment
- Cannot have finished TB treatment in the past 12 months. Cannot have taken any medicine that acts against mycobacteria (including fluoroquinolones) in the past 2 weeks.
- Biomarker or test result
- People with a risk factor must screen positive: for HIV, CRP above 5 mg/dL or an abnormal chest X-ray; for close contact or mining work, an abnormal chest X-ray. The drug-resistance part needs TB and RIF resistance on Xpert MTB/RIF, Xpert MTB/RIF Ultra or Hain MTBDRplus.
Main reasons for not taking part
- Finished TB treatment within the past 12 months
- Took medicine active against mycobacteria within the past 2 weeks
- Lives more than 20km (12 mi) from the study site or cannot return for follow-up
- Cannot give at least two sputum samples of 3 mL each (drug-resistance part)
- Unwilling to give informed consent
Read by machine on 10 November 2026.
Where in Zambia
- Centre for Infectious Disease Research in ZambiaLusaka, ZambiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of California, San Francisco
- Trial code
- NCT04923958
- Record updated
- 9 November 2026
- Original description
To reduce the burden of TB worldwide through more accurate, faster, simpler, and less expensive diagnosis of TB 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 Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) brings together experts in TB care, technology assessment, diagnostics development, laboratory medicine, epidemiology, health economics and mathematical modeling with highly experienced clinical study sites in 10 countries.Read full original descriptionShow less
Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study
To reduce the burden of TB worldwide through more accurate, faster, simpler, and less expensive diagnosis of TB 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 Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) brings together experts in TB care, technology assessment, diagnostics development, laboratory medicine, epidemiology, health economics and mathematical modeling with highly experienced clinical study sites in 10 countries.
Novel TB triage and diagnostic tests:; We 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:; PLHIV (Risk Factor), CRP >5 mg/dL OR abnormal CXR (Positive TB screening definition); Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition); History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition); We will exclude people who:; 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; Novel TB rDST assays:; We will include adults (age ≥12 years) who are positive for TB and RIF resistance according to routine diagnostic testing (based typically on Xpert MTB/RIF, Xpert MTB/RIF Ultra, or Hain MTBDRplus). We will exclude people who:; have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures; are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment; are unable or unwilling to provide informed consent; Assessment of the usability of novel TB tests:; We 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). We will exclude staff who are unwilling to provide informed consent.