Table 2.
Procedure | Assessment time |
|||||||
---|---|---|---|---|---|---|---|---|
Screening (weeks − 2 to − 4) | Enrolment (week 0) | Week 4 | Week 8 | Week 12 | Week 24 | Every 3 months after | Every 6 months after | |
Consent for screening | x | |||||||
Consent for plasma storage | x | |||||||
Consent for enrolment | x | |||||||
History & physical examinationa | x | x | x | x | x | x | x | |
CD4 countb | x | x | x | x | x | |||
Full blood count | x | x | x | x | ||||
Pregnancy testc | x | |||||||
Malaria slide | x | x | x | x | x | x | ||
Adherence assessment | x | x | x | x | x | x | ||
Study drug prescription/refill | x | x | x | x | x | x |
Doctor assessment. Including a record of all clinical events and any adverse events since previous visit.
CD4 counts at baseline, after first three months, after 6 months and then 6 monthly thereafter.
Pregnancy test in all women of reproductive age at screening. Thereafter, only in event of amenorrhea.