Screening and enrolment | Visit 1 | Visit 2 | Visit 3 | Contact 1 | 3-monthly follow up call (Group 8 only) | |
---|---|---|---|---|---|---|
Study day | Day 0 | M 3–7 days | M3 PET-CT | M3 + 7–14 days (Bronchoscopy) | 72 h and day 14 post bronchoscopy | Telephonic/home visit follow up |
Informed consent including bronchoscopy, PET-CT, and genetic testing | x | |||||
Inclusion/exclusion criteria | x | |||||
Targeted physical examination | x | x | xd | |||
TB symptom screen | x | x | x | |||
Vital signs and medical history | x | x | x | |||
Concomitant medications | x | |||||
Chest x-ray | x | xd | ||||
ECG (If clinically indicated) | x | |||||
IGRA | x | x | ||||
Finger prick blood (Hb, random glucose, HbA1c, if indicated) | x | xb | ||||
HIV-1 test and counselling | x | |||||
Sputum (GeneXpert® & MGIT) | x | xa | xd | |||
PAXgene® | x | |||||
Urine βHCG (all females) | x | x | xc | |||
NaHep (PBMC) | x | x | ||||
Bronchoscopy (BAL) | xe | |||||
Serum | x (SARS-CoV-2 serology) | x (storage) | x (SARS-CoV-2 serology) | x | ||
Nasopharyngeal Swab (for SARS-CoV-2 PCR & respiratory pathogen assays) | x | |||||
PET-CT | x | |||||
Phone call and symptom check | x |