CompletedNot Applicable

Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008

Botswana, Eswatini, Kenya5,694 participantsStarted 2024-09-13

Plain-language summary

This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Enrollment into the CoVPN 3008 clinical trial. * Able and willing to complete the informed consent process: Volunteer demonstrates an understanding of this substudy. * Willingness to discuss TB status, undergo related testing/monitoring labs, and receive referrals for TB care. Exclusion Criteria: * Investigator's concern for difficulty with venous access based on clinical history and physical examination.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants with TB

Timeframe: Measured at Day 1, Day 4 and week 26

Association parameters of each demographic variable with confirmed TB.

Timeframe: Measured at Day 1, Day 4 and week 26

Proportion of participants with confirmed TB at the six-month follow visit out of the total number of participants that are screened at the six-month visit and who had confirmed TB at their enrollment visit.

Timeframe: Measured at Day 1, Day 4 and week 26

Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB.

Timeframe: Measured at Day 1, Day 4 and week 26

Trial details

NCT IDNCT06585683

SponsorCOVID-19 Prevention Network

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2025-03-28

View on ClinicalTrials.gov More Tuberculosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of participants with TB

Timeframe: Measured at Day 1, Day 4 and week 26

Association parameters of each demographic variable with confirmed TB.

Timeframe: Measured at Day 1, Day 4 and week 26

Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB.

Timeframe: Measured at Day 1, Day 4 and week 26