| |
Screening
|
Enrollment
|
Every 4 weeks for 1st 24 weeks, then every 12 weeks
|
Additional evaluations every 24 weeks
|
Final study visit, time of termination
|
Premature discontinuation of study treatment
|
Unscheduled Visits
|
|---|
|
Informed consent
|
√
| | | | | | |
|
Review of past medical history
|
√
| | | | | | |
|
Review of current complaints
| |
√
|
√
| |
√
|
√
|
√
|
|
Medication history
|
√
| |
√
| |
√
|
√
| |
|
Bednet use
| |
√
|
√
| |
√
|
√
| |
|
WHO performance scale
| |
√
| |
√
|
√
|
√
| |
|
Complete blood count, alanine aminotransferase, creatinine
|
√
| | |
√
|
√
|
√
| |
|
Urine pregnancy test
|
√
|
√a
|
√a
| | | | |
|
CD4 count
|
√
| | |
√
|
√
|
√
| |
|
HIV viral load
|
√
| | |
√
|
√
|
√
| |
|
Filter paper sample
| |
√
|
√
| |
√
|
√
| |
|
Physical examination
|
√
|
√ (limited)
|
√ (limited)
|
√
|
√
|
√
|
√
|
|
Visual acuity assessment
| |
√
| |
√
|
√
|
√
| |
|
Provision of medication
| |
√
|
√
| | | | |
|
Pill count and adherence interview
| | |
√
| |
√
|
√
| |
-
aUrine pregnancy testing will be performed at all study visits only where pregnancy is suspected
