Overview
This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.
Description
This observational substudy will involve participants from the CoVPN 3008 trial, regardless of their HIV status, to study tuberculosis (TB). At the start, all participants will be screened for TB, even if they have no symptoms. They will receive chest x-rays and provide sputum samples for TB testing using Xpert Ultra, smear microscopy, and culture.
The study has two main groups. Group 1 includes participants with confirmed TB, and Group 2 includes participants without TB who will act as controls.
Participants with confirmed TB will start treatment and have a first follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. A second follow-up visit will take place at week 26 to evaluate their treatment progress, clinical outcomes, and TB status, ensuring they receive the necessary care.
Participants without TB will have a single follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. The study aims to identify potential biomarkers of TB by analyzing blood samples from both cases and controls, focusing on gene expression linked to TB, including hidden (subclinical) TB.
Eligibility
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.