Infant Biospecimen Tracking in Prospective Cohort Study of HIV and Zika in Infants and Pregnancy

Infant Biospecimen Tracking Dataset
Study Description
The aims of this two-phase study of pregnant women and their infants were to compare the incidence of ZIKV infection among pregnant women with and without HIV infection and to determine the risk of adverse maternal and child outcomes associated with ZIKV/HIV co-infection at clinical sites in Brazil, Puerto Rico, and the continental United States. Phase I was designed to enroll pregnant women/infant pairs who were infected with HIV only, infected with ZIKV only, infected with HIV and ZIKV, and not infected with either HIV or ZIKV. A key goal was to assess the feasibility of enrolling 200 women/infant pairs within a year, with a target of 150 WLHIV, 50 HIV-uninfected women, and a minimum of 20 who were co-infected with HIV/ ZIKV. If the feasibility of Phase I proved successful, Phase II would enroll additional pregnant women/infant pairs to the same four groups, and follow the women and the infants for one year after birth. Primary outcome measures noted HIV suppression at the time of delivery in HIV-infected alone versus HIV/ZIKV co-infected pregnant women, cumulative incidence of ZIKV infection during pregnancy among women with and without HIV infection, incidence of adverse pregnancy outcomes in each cohort and incidence of vertical transmission of HIV and/or ZIKV in women infected with HIV or ZIKV alone versus HIV/ZIKV Co-infection. Observed major congenital malformations were as follows: anhydramnios, cerebral ventriculomegaly, clubfoot, down syndrome, hydrops, hypospadias, patient ductus arteriosus, polydactyly, Potter syndrome, short stature, and syndactyly. Pregnant women/infant pairs who were: (1) infected with HIV only; (2) infected with Zika virus (ZIKV) only; (3) infected with HIV and ZIKV; and (4) not infected with HIV or ZIKV.