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 range18 Years

SexALL

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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.

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

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