Visit Number | 0.0 | 1.0 | 2.0 | 3.0 | 4.0 | 5.0 | 6.0 | 7.0 |
---|---|---|---|---|---|---|---|---|
Gestational Age (weeks) | < 24 | 16–23 | 24 | 28 | 32 | 36 | Deliveryc | 42 days |
Administrative/regulatory procedures | ||||||||
Informed consent | ● | |||||||
Confirmation of eligibility | ● | |||||||
Collection/review of locator info | ● | ● | ● | ● | ● | ● | ● | ● |
Randomization | ● | |||||||
Clinical/behavioral procedures | ||||||||
Ultrasounda | ● | ● | ● | |||||
Obstetrical history | ● | |||||||
Medical history and clinical exama | ● | ● | ● | ● | ● | ● | ||
Concomitant medication assessment | ● | ● | ● | ● | ● | ● | ||
Demographic history | ● | |||||||
Behavioral and nutritional assessment | ● | ● | ||||||
Maternal depression screen | ● | ● | ||||||
Infant clinical assessment | ● | ● | ||||||
Study product procedures | ||||||||
17P Adherence counselingb | ● | ● | ● | ● | ● | |||
Study drug injectionsb | ● | ● | ● | ● | ● | |||
Side effects assessmentb | ● | ● | ● | ● | ||||
Laboratory procedures | ||||||||
Maternal rapid HIV a | ● | |||||||
Maternal pregnancy testa | ● | |||||||
Maternal rapid syphilis a | ● | |||||||
Maternal candida, gram staina | ● | |||||||
Maternal hemoglobin (HemoCue)a | ● | ● | ||||||
Maternal urinalysisa | ● | ● | ||||||
Maternal viral load and T cell assays | ● | ● | ● | |||||
Placenta, membranes, cord blood storage | ● | |||||||
Infant HIV DNA PCRa | ● | |||||||
Vaginal-rectal swab storage | ● | ● | ● | ● | ||||
Blood storage | ● | ● | ● | ● | ||||
Urine storage | ● | ● | ● | ● |