Clinical Study of STI Screening to Prevent Adverse Birth and Newborn Outcomes

性传播感染筛查预防不良分娩和新生儿结局的临床研究

基本信息

批准号：
10385627
负责人：
Jeffrey David Klausner
金额：
$ 96.31万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-01-07 至 2024-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10385627
关键词：
Aftercare Algorithms Bacteria Bacterial Vaginosis Biological Factors Birth Chlamydia Infections Chlamydia trachomatis Clinic Clinical Research Collaborations Communities Data Diagnostic tests Enrollment Frequencies Guidelines HIV HIV Infections HIV Seropositivity Hybrids In Vitro Incidence Infection Intervention Lactobacillus Low Birth Weight Infant Metronidazole Modeling Molecular Mother-to-child HIV transmission National Institute of Child Health and Human Development Neisseria gonorrhoeae Newborn Infant Outcome Outcome Study Perinatal mortality demographics Play Pregnancy Pregnant Women Premature Birth Premature Labor Premature Rupture Fetal Membranes Prevalence Randomized Research Research Personnel Resources Risk Role Sexually Transmitted Diseases Site South Africa South African Specimen Syndrome Testing Time Treatment Failure Treatment outcome Trichomonas vaginalis Update Vagina Visit Woman Work acceptability and feasibility adverse birth outcomes adverse pregnancy outcome antenatal care arm care delivery care systems case control chronic infection congenital infection cost cost effective cost effectiveness cost estimate diagnostic screening disability-adjusted life years effectiveness trial experience follow-up infant outcome innovation low and middle-income countries male neonate novel point of care prevent response screening screening guidelines standard of care treatment duration treatment guidelines vaginal microbiome vaginal microbiota

项目摘要

ABSTRACT Infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) during pregnancy are associated with premature rupture of membranes, preterm labor and delivery, low birth weight, congenital infections, perinatal death and mother-to-child transmission of HIV infection. Sexually transmitted infections (STIs) like these are common in pregnant women globally, but often go undiagnosed; recent work by our group found a 41% STI prevalence amongst HIV-infected pregnant women, of which 64% of infections were asymptomatic. Recent research suggests the vaginal microbiome may play a critical role in STI acquisition, persistence and treatment outcomes. Our pilot work has shown that diagnostic testing for CT, NG, and TV in antenatal care services for HIV-infected pregnant women in South Africa is highly acceptable and feasible; however, our work has made clear that evaluating the impact and cost effectiveness of different diagnostic screening strategies that optimally decrease the burden of STIs during pregnancy and at time-of-delivery is urgently needed. Furthermore, our findings highlight that biological factors that increase the risk for STI persistence and/or treatment failures must be further investigated. In response to the need to 1) identify optimal, cost-effective screening strategies that decrease the burden of STIs during pregnancy and reduce adverse birth outcomes, 2) provide evidence to update WHO's syndromic management guidelines, and 3) elucidate the role of the vaginal microbiome in STI treatment outcomes, we propose a novel, highly innovative study with the following three Aims: Aim 1: Evaluate 3 different screening strategies to decrease the burden of CT/NG/TV among pregnant women, and reduce adverse birth outcomes. Aim 2: Evaluate cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per STI and disability-adjusted life-year (DALY) averted. Aim 3: Investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women. Our proposed 5-year study will enroll 1250 HIV-infected and 1250 uninfected pregnant women from three large ANC clinics in Tshwane District, South Africa, as well as their ~2500 neonates and up to 834 male partners. Our research team, led by established researchers, has significant expertise and experience in all aspects of the proposed study. Our multi-institutional collaborations will allow us to leverage unique implementation platforms and resources, and allow for rapid dissemination of findings to South African and global stakeholders.

抽象的感染期间沙眼衣原体 (CT)、淋病奈瑟菌 (NG) 和阴道毛滴虫 (TV) 怀孕与胎膜早破、早产和分娩、低出生体重、先天性感染、围产期死亡和艾滋病毒感染的母婴传播。性传播此类感染（性传播感染）在全球孕妇中很常见，但往往未被诊断出来；最近的工作我们的小组发现，感染艾滋病毒的孕妇中性传播感染的患病率为 41%，其中 64% 的感染是无症状。最近的研究表明，阴道微生物组可能在性传播感染中发挥着关键作用，持续性和治疗结果。我们的试点工作表明，CT、NG 和 TV 的诊断测试南非为感染艾滋病毒的孕妇提供的产前保健服务是高度可接受和可行的；然而，我们的工作已经明确表明，评估不同诊断的影响和成本效益最佳地减轻妊娠期间和分娩时性传播感染负担的筛查策略急需。此外，我们的研究结果强调，增加性传播感染风险的生物因素必须进一步调查持久性和/或治疗失败。为了满足以下需求： 1) 确定最佳的、具有成本效益的筛查策略，以减轻患者的负担妊娠期间性传播感染并减少不良出生结局，2) 为更新世界卫生组织的综合征提供证据管理指南，以及 3) 阐明阴道微生物组在 STI 治疗结果中的作用，我们提出一项新颖的、高度创新的研究，其目标如下：目标 1：评估 3 种不同的筛查策略，以减轻孕妇 CT/NG/TV 的负担妇女，并减少不良分娩结果。目标 2：评估每位孕妇接受筛查和治疗的成本、不良分娩结果的成本以及每个 STI 的成本效益和避免的伤残调整生命年 (DALY)。目标 3：研究阴道微生物组与持久性衣原体之间的关系孕妇感染。我们提议的为期 5 年的研究将招募来自三个大国家的 1250 名 HIV 感染者和 1250 名未感染的孕妇。南非茨瓦内区的 ANC 诊所及其约 2500 名新生儿和多达 834 名男性伴侣。我们的由知名研究人员领导的研究团队在各个方面都拥有丰富的专业知识和经验提议的研究。我们的多机构合作将使我们能够利用独特的实施平台和资源，并允许向南非和全球利益相关者快速传播研究结果。