Using cough sounds to identify tuberculosis

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

This observational study evaluates the potential of a smartphone application that analyzes cough audio to triage patients for tuberculosis (TB) detection. Participants aged 12 and older with a cough lasting more than two weeks will be recruited from healthcare clinics in high-burden settings. The study consists of two phases: the first phase collects data to train a machine learning algorithm, while the second phase validates the algorithm's performance with a larger participant group. The goal is to develop a reliable cough audio classifier that meets World Health Organization criteria for TB triage tests.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* participant must be at least 12 years old
* participant must have a prolonged cough (for at least two weeks)
* participant must provide informed consent
* participant shall have a known HIV status or be willing to undergo standard of care HIV testing and counseling

Exclusion Criteria:

* individuals who refuse informed consent
* individuals who have received treatment for TB in the 60 days prior to enrolment
* individuals who are unable to provide a sputum specimen for microbiological testing
* individuals who have haemoptysis or a bloody cough with any forced coughs for audio recordings

Where it's running

• Stellenbosch University
  Cape Town, Western Cape, South Africa Recruiting
• Makerere University
  Kampala, Kampala, Uganda Recruiting

Study contacts

• Principal investigator: Grant Theron, PhD — University of Stellenbosch
• Study coordinator: Grant Theron, PhD
• Email: gtheron@sun.ac.za
• Phone: +27 21 9389693

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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.