Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial

Table 1 IPOP study schedule of evaluations

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	Delivery^c	42 days
Administrative/regulatory procedures
Informed consent	●
Confirmation of eligibility		●
Collection/review of locator info	●	●	●	●	●	●	●	●
Randomization		●
Clinical/behavioral procedures
Ultrasound^a	●	●			●
Obstetrical history	●
Medical history and clinical exam^a	●		●		●	●	●	●
Concomitant medication assessment	●		●		●	●	●	●
Demographic history	●
Behavioral and nutritional assessment	●							●
Maternal depression screen	●							●
Infant clinical assessment							●	●
Study product procedures
17P Adherence counseling^b		●	●	●	●	●
Study drug injections^b		●	●	●	●	●
Side effects assessment^b			●	●	●	●
Laboratory procedures
Maternal rapid HIV ^a	●
Maternal pregnancy test^a	●
Maternal rapid syphilis ^a	●
Maternal candida, gram stain^a	●
Maternal hemoglobin (HemoCue)^a	●				●
Maternal urinalysis^a	●				●
Maternal viral load and T cell assays	●		●				●
Placenta, membranes, cord blood storage							●
Infant HIV DNA PCR^a								●
Vaginal-rectal swab storage	●		●	●			●
Blood storage	●		●	●			●
Urine storage	●		●	●			●

^aPerformed as standard antenatal care
^bOccurs weekly through week 36, or until delivery, whichever occurs first
^cAll procedures may not be completed for women who deliver off-hours or in a location without staff coverage

ISSN: 1471-2393