| 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 |  |  | √ |  | √ | √ |  |