Table 3. ACT HIV trial assessment schedule.
DAYS MONTHS | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
SCREENING | 0 | 3 | 7 | W
eekly until
discharge |
30 | 60 | M
onthly to anti-TB
drug end |
12 | 18 | 24 | |
ALL PARTICIPANTS | |||||||||||
Eligibility assessment | (X) | ||||||||||
Participant information
sheet and consent |
X | ||||||||||
Randomisation | X | ||||||||||
Clinical assessment | (X) | X | X | X | X | X | X | X | X | X | X |
Disability assessment | X | X | X | X | X | X | |||||
Chest X-ray | (X) | X | X | ||||||||
Lumbar puncture (with
paired plasma glucose) CSF Cryptococcal Ag test |
(X)
(X) |
X | X | ||||||||
HIV test | (X) | ||||||||||
EDTA blood for genetic
tests Full blood count CD4 count HIV viral load Storage for later DNA extraction |
(X) (X) |
X
X X |
(X) |
X |
|||||||
Sodium
Urea/Creatinine ALT/ bilirubin Hepatitis C antibodies Hepatitis B surface antigen Fasting blood sugar/ HbA1c C-peptide/Lipids Strongyloides serology Serum Storage |
(X)
(X) (X) |
X X X X X X |
(X) |
(X)
(X) (X) |
X |
(X)
(X) |
|||||
Stool for Ova, cysts and
parasites (Strongyloides) microscopy |
X | X | |||||||||
SUBSET OF PARTICIPANTS RECRUITED TO IMAGING STUDY (HTD Vietnam only) | |||||||||||
Brain MRI | X | X | X | ||||||||
SUBSET OF PARTICIPANTS RECRUITED TO HYPONATRAEMIA/ICP ANCILLARY STUDY (HTD Vietnam only) | |||||||||||
24-hour fluid balance | (X) | X | X | X | X | ||||||
Plasma sodium
Plasma osmolality |
X | X | X | X | |||||||
Urinary sodium
Urinary osmolality |
X | X | X | X | |||||||
Plasma cortisol | X | ||||||||||
Ultra-sound assessment
of intravascular volume |
X | X | X | X | |||||||
Ultra-sound measurement
of optic nerve sheath diameter |
X | X | X | X | |||||||
SUBSET OF PARTICIPANTS RECRUITED TO ADRENAL SUPPRESSION ANCILLARY STUDY (HTD Vietnam only) | |||||||||||
Synacthen test | X (day 21) | X |