SECONDARY DATA ANALYSES AND INVESTIGATION OF RESEARCH CONCEPT PROPOSALS FROM THE PROSPECTIVE COHORT OF HIV AND ZIKA IN INFANTS AND PREGNANCY STUDY (HIV-ZIP)

艾滋病毒邮政编码研究完成了200名孕妇的登记(174名艾滋病毒感染者和26名艾滋病毒感染者 未感染的)和195名居住在美国、波多黎各和巴西的后代。为 研究完成，主要研究任务与支持研究监测活动有关 最后一次参与者访问、数据清理和数据分析。HIV ZIP的最后一次产妇分娩 发生在2019年6月，最后一次参与者(婴儿)探视发生在2020年9月。数据清理 最终数据集和数据库锁定于2020年12月30日完成。交付期末产品 这项研究的统计学家的数据集发生在2021年1月20日。 HIV ZIP是一项对孕妇和她们的预期国际队列的可行性研究 那些怀孕的婴儿。它的目标是评估比较研究的可行性 寨卡病毒(ZIKV)感染在孕妇中的发病率 免疫缺陷病毒(HIV)感染，并确定与以下相关的不良后果风险 ZIKV/HIV在美国大陆(美国)、波多黎各(PR)和 巴西。 这项研究的目的是(1)确定令人满意地实现应计目标的可行性，(2) 确认统计假设的充分性，以考虑未来的功率和样本量 在这一患者群体中进行大规模研究，以及(3)提供足够的统计能力来检测临床 HIV感染妇女中未抑制HIV病毒载量的比例有意义的差异 在感染寨卡病毒的艾滋病毒感染女性和未感染寨卡病毒的艾滋病毒感染女性之间，假设10% 在登记的艾滋病毒感染妇女中(并符合寨卡病毒风险标准)，有分娩感染寨卡病毒。 编写一份涉及上述每个主题的报告的初步研究分析 无法完成，因为第一阶段的可行性目标没有实现(即，注册至少10% 同时感染艾滋病毒和寨卡病毒的妇女)。尽管如此，礼宾团队开发了 许多研究概念与其他主要和次要研究目标保持一致。这些 研究概念涉及艾滋病毒治疗和孕妇之间的疾病参数比较 巴西和美国艾滋病毒携带者的一般和与艺术相关的发展成果 婴儿，环境暴露对艾滋病毒携带者妇女生育结局的影响， 巨细胞病毒在感染艾滋病毒的妇女和婴儿发育结局中的脱落，以及 Tdap在HIV感染孕妇体内的免疫原性及其被动获得性抗体 婴儿。

The HIV ZIP study completed enrollment of 200 pregnant women (174 HIV infected and 26 HIV uninfected) and 195 of their offspring who resided in the United States, Puerto Rico, and Brazil. For study completion, the primary study tasks relate to supporting study monitoring activities through the last participant visit, data cleaning, and data analysis. The last maternal delivery visit for HIV ZIP occurred in June 2019, and the last participant (infant) visit occurred in September 2020. Data cleaning of the final datasets and database lock were completed on December 30, 2020. Delivery of the final dataset to the study statisticians occurred on January 20, 2021. HIV ZIP was a feasibility study of a prospective international cohort of pregnant women and their infants from those pregnancies. Its goals were to evaluate the feasibility of a comparative study of the incidence of Zika virus (ZIKV) infection among pregnant women with and without Human Immunodeficiency Virus (HIV) infection and to determine the risk of adverse outcomes associated with ZIKV/HIV co-infection across clinical sites in the continental United States (U.S.), Puerto Rico (P.R.), and Brazil. The study was designed to (1) determine the feasibility of satisfactorily achieving accrual targets, (2) confirm the adequacy of statistical assumptions for power and sample size considerations for a future large scale study in this patient population, and (3) provide adequate statistical power to detect clinical meaningful differences in the proportions of HIV-infected women with unsuppressed HIV viral load between HIV-infected women with Zika and HIV-infected women without Zika infection, assuming 10% of the HIV-infected women enrolled (and meeting Zika risk criteria) have ZIKV infection by delivery. The primary study analysis of producing a report that addresses each of the topics enumerated above could not be fulfilled because Phase I’s feasibility objective was not achieved (i.e., to enroll at least 10% of women who were co-infected with HIV and Zika). Nevertheless, the protocol team developed numerous research concepts that align with the other primary and secondary study objectives. These research concepts address HIV treatment and disease parameter comparisons between pregnant women living with HIV in Brazil and the U.S., general and ART-related developmental outcomes on infants, the impact of environmental exposures on birth outcomes among women living with HIV, cytomegalovirus shedding in HIV-infected women and infant development outcomes, and the immunogenicity of Tdap in HIV-infected pregnant women and passively acquired antibodies in their infants.