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Testing Tongue Swabs to Detect Tuberculosis at the Point of Care

Tests tongue swab-based molecular assays for tuberculosis in people aged 12 and older.

Key facts

Who runs it
University of California, San Francisco
Where
Abuja, NigeriaSee the siteAlso in 2 other countries, 2 sites
Trial code
Registry title
Assessing Diagnostics At Point-of-care for Tuberculosis
Status
Recruiting
People taking part
1,350 people, planned
Started
28 Aug 2023
Expected to end
30 Sept 2028
Type of study
Interventional
Treatments tested
  • Tongue swab-based molecular assays
Record updated
2 September 2026

Who can take part

AI summary

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 adults and young people (12 and older) who are not in hospital and have a cough for 2 weeks or more, or a TB risk factor and a positive TB screen. It also includes health workers who do TB testing.

Age
People 12 years and older for the test study; health workers 18 years and older.
Sex
All sexes can join.
Disease stage
People who may have lung TB: cough for 2 weeks or more, or a TB risk factor (HIV infection, close contact with a TB patient, past mining work) plus a positive TB screen.
Earlier treatment
People who finished latent or active TB treatment in the past 12 months cannot join. People who took any medicine against mycobacteria (including fluoroquinolones) in the past 2 weeks cannot join.
Biomarker or test result
For people with HIV: C Reactive Protein (CRP) above 5 mg/dL or an abnormal chest x-ray. For close contacts and past miners: an abnormal chest x-ray.

Main reasons for not taking part

  • Finished TB treatment in the past 12 months
  • Took a medicine against mycobacteria, including fluoroquinolones, in the past 2 weeks
  • Lives more than 20km (12 mi) from the study site or will not return for follow-up visits
  • Is in hospital
  • Does not agree to give informed consent

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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
  • 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)

Who cannot take part

  • Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives)
  • Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively)
  • 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:
  • The investigators will exclude staff who are:
  • unwilling to provide informed consent

Other criteria

  • Novel TB triage and diagnostic tests:

Where in Nigeria

Also in 2 other countries, 2 sites

  • Zankli Research Center, Bingham UniversityAbuja, NigeriaContact: John BimbaTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Evaluation of various novel TB triage and diagnostic testsTreatment being tested

    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.

    Treatment: Tongue swab-based molecular assays

Results explained

A paper that names this trial, explained in plain words.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Supporting, Mobilizing and Accelerating Research for Tuberculosis Elimination (SMART4TB)- Technical Area (TA) 1: Diagnostics- Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)
Plain-language title
Testing Tongue Swabs to Detect Tuberculosis at the Point of CareGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
2 September 2026