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. 2018 Jul 10;3:83. [Version 1] doi: 10.12688/wellcomeopenres.14691.1

Table 6. Out-patient schedule of events.

Study visit Week 4 Week 8 Week 12 Week 18 Week 24 Sick Visit
Visit window (weeks) ±1 ±1 ±1 ±2 ±2 As needed
Dispensing of study drug X standard fixed dose therapy til 12 months as
per local guidelines
Interim history X X X TELEPHONE CONSULTATION OR IN PERSON X X
Adverse events assessment X X X X X
Medication review X X X X X
Examination X X X X X
Modified Rankin score X X
Detailed neurocognitive follow-up X X
Center for Epidemiological Studies
of Depression Scale (CES-D)
X X
Sodium, potassium X (if clinically
indicated)
Creatinine X (if clinically
indicated)
Hepatic Panel a X X X (if clinically
indicated)
FBC, differential b X (if clinically
indicated)
Storage bloods c X X (IRIS event
only)
CSF with storage X (if clinically
indicated)
ART counselling d X X
Commence/switch ART d X
Total volume of blood (ml) 20 20

aHepatic panel = ALT, ALP, bilirubin +/- INR

bFBC; full/complete blood count

cBlood will be collected and stored for research if storage consent has been received, refer to site SOP.

dHIV-infected patients not receiving effective ART, ART counselling to be performed by qualified counsellors as per standard clinic procedures. Physician discretion allowed for timing of ART initiation.