Study schedule of enrolment, interventions and assessments.
Study period | ||||||||||||||||
Enrolment | Allocation | Intensive phase of ATT (Trial period) | Continuation phase of ATT (Post-trial period) | Closeout | ||||||||||||
I | Enrolment | Baseline (-D7) | W 0 | W 1 | W 2 | W 3 | W 4 | W 5 | W 6 | W 7 | W 8 | M 3 | M 4 | M 5 | M 6 | M 7 |
1 | Informed consent | x | ||||||||||||||
2 | Eligibility screen (including laboratory tests) | x | ||||||||||||||
3 | Sputum Gene Xpert | x | ||||||||||||||
4 | HIV, hepatitis B and C | x | ||||||||||||||
II. | Allocation | x | ||||||||||||||
III | Trial regimens | |||||||||||||||
Test regimen (metformin containing ATT) | x | x | x | x | x | x | x | x | x | |||||||
Control regimen (only ATT) | x | x | x | x | x | x | x | x | ||||||||
Continuation phase of ATT (for both groups) | x | x | x | x | ||||||||||||
IV | Assessments | |||||||||||||||
1 | Clinical evaluation | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
2 | Sociological assessment | x | x | x | x | x | x | x | x | x | ||||||
3 | Sputum smear and culture (MGIT, LJ) | x | x | x | x | x | x | x | x | x | x | x | x | x | ||
4 | Urine pregnancy tests/sugar/Alb | x | x | x | x | x | x | x | ||||||||
5 | HbA1c | x | x | x | ||||||||||||
6 | CBC, LFT, RFT, lactic acid, peripheral smear and chest X-ray | x | x | x | x | |||||||||||
7 | Random blood sugar | x | x | x | x | x | x | |||||||||
8 | Pharmacokinetics and genomics | x | x | |||||||||||||
9 | Immunological studies | x | x | x | ||||||||||||
10 | Storage plasma/cell sample | x | x | x | x | |||||||||||
V | Outcomes | x |