Infant Follow-up Feeding/ZIKV Symptoms Questionnaire in Prospective Cohort Study of HIV and Zika in Infants and Pregnancy

Infant Follow-up Feeding/ZIKV Symptoms Questionnaire 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.

婴儿随访喂养/寨卡病毒（ZIKV）症状问卷数据集
研究描述
本研究为针对孕妇及其婴儿开展的两阶段队列研究，旨在对比伴与不伴人类免疫缺陷病毒（HIV）感染的孕妇群体中寨卡病毒（ZIKV）感染发生率，并明确巴西、波多黎各及美国本土临床机构中，HIV与ZIKV合并感染相关的不良母婴结局风险。
第一阶段的入组对象分为四组：仅感染HIV者、仅感染ZIKV者、同时感染HIV与ZIKV者，以及未感染上述两种病原体的受试者。本阶段核心目标为评估1年内招募200对母婴的可行性，预设招募指标为150名HIV感染孕妇、50名HIV阴性孕妇，且至少纳入20名HIV/ZIKV合并感染者。若第一阶段可行性验证通过，第二阶段将继续招募符合上述四组分类的新增母婴对，并在产后对孕妇及婴儿开展为期1年的随访。
本研究的主要结局指标包括：仅HIV感染孕妇与HIV/ZIKV合并感染孕妇分娩时的HIV病毒抑制情况；伴与不伴HIV感染的孕妇在孕期的ZIKV感染累积发生率；各队列的不良妊娠结局发生率；仅感染HIV或ZIKV的孕妇，相较于HIV/ZIKV合并感染者，其HIV和/或ZIKV的垂直传播发生率。
本次观测到的严重先天性畸形包括：羊水过少、脑室扩张、马蹄内翻足、唐氏综合征、胎儿水肿、尿道下裂、动脉导管未闭、多指（趾）畸形、波特综合征、身材矮小以及并指（趾）畸形。
本研究的入组母婴对分为以下四类：（1）仅感染HIV者；（2）仅感染寨卡病毒（ZIKV）者；（3）同时感染HIV与ZIKV者；（4）未感染上述两种病原体者。