How we intend to execute CageTB

We use clinics for many different reasons.
Many people at the clinic can have more than one condition that needs treatment.
In Africa, this other condition is often TB, and it is often missed.

For example, if you come to get your diabetes or HIV medication and have a cough, which is a symptom of TB, you need more testing to check if you really have TB—because many different things can cause a cough (like allergies).

We want to see if we can “hear” if the cough sounds different depending on whether someone has TB (we will also confirm using safe procedures).

In the future, we hope to make a cellphone app that can listen to a cough and check if it sounds like TB.

Only people whose cough sounds like TB would then need more tests.

We want to do projects like this in communities like yours, where they could make a big difference.

Participating in the CAGE-TB Study

To participate in CAGE-TB, you need to:

• Be 12 years or older.
• Report a cough for 2 weeks or longer.
• Provide informed consent.
• Have a known HIV status or be willing to undergo standard of care HIV testing and counseling.

What is needed from you if you would like to participate?

We will collect cough sound audio, sputum (coughed up saliva), blood (a very low amount), nasal swab, urine, and a chest X-ray from you.

Chest X-ray will not be done if you are pregnant.

These samples will be collected once and close together.

We will only need a few hours of your time.

The study will be beneficial to you as you will receive TB testing (many people who need a TB test do not ordinarily get it) and this would be rapid.

Any abnormal results like a chest X-ray will mean you will be referred to your local clinics for healthcare and treatment. Not everyone usually can get a chest X-ray. Chest X-rays are useful for finding problems other than TB (like cancer).

Are children allowed to participate?

• Yes if 12 years or over. Children are at risk for TB and often get ignored when testing new TB tests. We want to also help children.

• Children aged between 12 and 17 can be accompanied by a parent or guardian if they would like. However, this is NOT necessary.

Are there any risks?

Your safety is the most important, and you can be rest assured that it is safe for you to visit the clinic to participate in the study.
Our staff are vaccinated against SARS-CoV-2 (COVID-19) and will follow specific measures to ensure that you are protected.

There are minimal risks:

• You might feel a little uncomfortable or there might be slight bruising when blood is drawn, but this is completely safe. It is a few teaspoons and can be stopped any time.

• Chest X-rays expose you to a very small amount of radiation.

• Chest X-rays will not be done on pregnant participants.

• Your identity, medical and any personal information you share with our study staff will be kept confidential and anonymous in our secure database.

What will happen to your samples after collection?

We will do tests and measurements on them to check if the samples from people with TB are different from those of people without TB.