Table 5. Outpatient Schedule of events.
| Study item | Wk 2 * | Wk 4 | Wk 8 | Wk 12 | Wk 18 | Wk 24 | Wk 36 | Wk 52 | Sick Visit |
|---|---|---|---|---|---|---|---|---|---|
| Visit window (weeks) | (1,3) | (3,6) | (6, 10) | (10, 13) | (13, 21) | (21, 30) | (30, 44) | (44, 60) | As needed |
| Dispensing of study
drug |
X | X | X | standard fixed dose therapy for 7–10 months as per local guidelines | |||||
| Interim history | X | X | X | X | X | X | X | X | |
| AE assessment | X | X | X | X | X | X | X | X | |
| Medication review | X | X | X | X | X | X | X | X | X |
| Adherence assessment | X | X | X | X | X | X | X | X | X |
| Physical Examination | X | X | X | X | X | X | |||
| Liverpool Outcome
Score |
X | ||||||||
| Detailed neurocognitive
follow-up (Uganda) |
X | X | |||||||
| Sodium | ±
if clinically indicated |
||||||||
| Creatinine | ±
if clinically indicated |
||||||||
| Liver Panel a | X | X | X | ±
if clinically indicated |
|||||
| Full blood count,
differential |
±
if clinically indicated |
||||||||
| CSF analysis & storage | ±
if clinically indicated |
||||||||
| Initiate or switch ART b | X | ||||||||
| Storage of blood (ml) | X (if
ART PK) |
X (optional,
HIV-pos) |
X (optional,
HIV-pos) |
12 if
clinically indicated |
|||||
Footnotes:
*week 2 visit may be performed as an inpatient or outpatient depending on the time of hospital discharge
All visits should ideally take place in person but can, in certain circumstances, be done by telephone or via home visit (if patient consents)
aLiver panel = ALT; alanine aminotransferase, ALP; alkaline phosphatase, total bilirubin
b HIV-infected patients not receiving effective ART. ART initiation via local HIV service and in-line with ART management SOP.
AE = adverse event, CSF = cerebrospinal fluid, ART = antiretroviral therapy