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

二手数据分析和调查婴儿和妊娠研究中艾滋病毒和寨卡病毒前瞻性队列的研究概念提案 (HIV-ZIP)

• 批准号: 10576710
• 负责人: BARBARA DRIVER
• 金额: $ 146.64万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-12 至 2024-11-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10576710
• 关键词: Address; Adolescence; Adolescent; Antibodies; Behavioral; Birth; Brazil; Child; Childhood; Clinical; Clinical Trials; Cohort Studies; Collection; Communicable Diseases; Comparative Study; Contractor; Country; Cytomegalovirus; Data; Data Analyses; Data Set; Databases; Development; Disease; Enrollment; Environmental Exposure; Environmental Impact; Feasibility Studies; Fetal Development; Future; Goals; Growth and Development function; HIV; Incidence Study; Individual; Infant; Infant Development; Infection; Intellectual functioning disability; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Investigation; Knowledge; Laboratories; Manuscripts; Medical; Mission; Monitor; Morbidity - disease rate; National Institute of Child Health and Human Development; Outcome; Participant; Phase; Placenta; Postpartum Women; Pregnancy; Pregnant Women; Prevention; Prospective cohort; Protocols documentation; Psyche structure; Publications; Puerto Rico; Reporting; Research; Research Support; Risk; Sample Size; Sampling; Science; Site; Specimen; United States; United States National Institutes of Health; Viral Load result; Virus Diseases; Visit; Woman; ZIKA; ZIKV infection; Zika Virus; adverse outcome; clinical research site; co-infection; cohort; comorbidity; data cleaning; design; immunogenicity; infancy; knowledge base; meetings; mortality; offspring; patient population; pregnant; prevent; prospective; research and development

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.

HIV ZIP 研究完成了 200 名孕妇的入组（174 名 HIV 感染者和 26 名 HIV 感染者） 未感染）及其居住在美国、波多黎各和巴西的 195 名后代。 研究完成后，主要研究任务涉及通过以下方式支持研究监测活动： 最后一次参与者访视、数据清理和数据分析 最后一次 HIV ZIP 产妇分娩访视。 发生在 2019 年 6 月，最后一次参与者（婴儿）访问发生在 2020 年 9 月。 数据清理 最终数据集的整理和数据库锁定已于2020年12月30日完成。最终数据的交付 向研究统计学家提供的数据集发生于 2021 年 1 月 20 日。 HIV ZIP 是一项前瞻性国际孕妇队列的可行性研究 其目标是评估比较研究的可行性。 有或没有人类感染的孕妇中寨卡病毒（ZIKV）感染的发生率 免疫缺陷病毒 (HIV) 感染并确定与此相关的不良结果的风险 美国本土 (U.S.)、波多黎各 (P.R.) 和波多黎各 (P.R.) 临床地点的 ZIKV/HIV 混合感染 巴西。 该研究旨在 (1) 确定圆满实现应计目标的可行性，(2) 确认未来功效和样本量考虑因素的统计假设的充分性 对该患者群体进行大规模研究，并且（3）提供足够的统计能力来检测临床 HIV 病毒载量未受抑制的 HIV 感染女性比例存在显着差异 感染寨卡病毒的艾滋病毒女性与未感染寨卡病毒的艾滋病毒感染女性之间的比较，假设为 10% 登记的感染艾滋病毒的妇女（并符合寨卡风险标准）在分娩时感染了寨卡病毒。 生成解决上述每个主题的报告的主要研究分析 无法实现，因为第一阶段的可行性目标没有实现（即招收至少 10% 尽管如此，方案团队仍制定了同时感染艾滋病毒和寨卡病毒的妇女人数。 许多研究概念与其他主要和次要研究目标相一致。 研究概念涉及孕妇之间的艾滋病毒治疗和疾病参数比较 巴西和美国感染艾滋病毒的女性的一般和与抗逆转录病毒疗法相关的发展结果 婴儿、环境暴露对感染艾滋病毒的妇女出生结果的影响、 HIV 感染妇女中巨细胞病毒的脱落和婴儿发育结果，以及 Tdap 在 HIV 感染孕妇中的免疫原性及其被动获得抗体 婴儿。