Can a simple breath test catch flu in High-HIV regions?

NCT ID NCT07030075

Knowledge-focused Sponsor: Centre for Infectious Disease Research in Zambia Source: ClinicalTrials.gov ↗

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study in Lusaka, Zambia, aims to measure how common influenza, RSV, and COVID-19 are among adults with flu-like symptoms, comparing those with and without HIV. Researchers will follow participants for two weeks to track symptom progression and outcomes. They will also test whether a breath-based sampling method can accurately detect these viruses compared to standard nasal swabs, and ask participants about their experience with each method.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Exhaled breath aerosol sampling (a non-invasive diagnostic method)
What this could lead to: If successful, this could improve flu diagnosis in high-HIV settings and support faster, more acceptable testing for respiratory infections.
What could go wrong: This is an observational study, so it won't test a treatment. The breath sampling method may not be as accurate as standard swabs, and results may not apply beyond this specific population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 594 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Persons encountered at the facility entry points will be informed of the study through sensitization activities. Entry points will include the outpatient departments (OPD), emergency room, antiretroviral therapy (ART) clinics, chest clinics, and maternal and child health (MCH) clinics. All adults over the age of 18 years old presenting with flu-like symptoms will be screened for eligibility.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age ≥18 years old * presenting with flu-like symptoms or acute respiratory infection with ≥2 to 7 days history of cough and /or sore throat and fever, +/- sneezing, +/- congestion, +/- myalgia, +/- fatigue, +/- wheezing, shortness of breath)\[55-57\] * willing to share their HIV status or be tested * willing to share their COVID-19 vaccination status * able and willing to give informed consent * willing to provide a nasal/ nasopharyngeal sample for testing as part of standard of care * willing to provide exhaled breath aerosol samples i.e. wear a mask and provide a breath sample * willing to fill a symptoms diary card for symptom tracking for 7 days * agree to be followed-up and attend study visits up to two weeks after study entry Exclusion Criteria: * individuals who are unwilling to provide any reference standard samples such as the nasopharyngeal swabs * those with symptoms for \>7 days, or * those unwilling or unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

COVID-19 influenza respiratory syncytial virus infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 Influenza RSV

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a simple breath test catch flu in High-HIV regions?

What the study statuses mean