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.

艾滋病毒ZIP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）