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

• 批准号: 10555240
• 负责人: Jeffrey David Klausner
• 金额: $ 95.93万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 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/10555240
• 关键词: Aftercare; Agreement; Algorithms; Bacteria; Bacterial Vaginosis; Biological Factors; Birth; Chlamydia Infections; Chlamydia trachomatis; Clinic; Clinical Research; Collaborations; Communities; Cost Analysis; Data; Diagnostic tests; Enrollment; Frequencies; Guidelines; HIV; HIV Infections; HIV Seropositivity; Hybrids; In Vitro; Incidence; Infection; Institution; 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; Prevalence; Randomized; Research; Research Personnel; Resources; Risk; Role; Sexually Transmitted Diseases; Signs and Symptoms; Site; South Africa; South African; Specimen; 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 systems; case control; chronic infection; congenital infection; cost; cost comparison; 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; preterm premature rupture of membranes; prevent; response; screening; screening guidelines; standard of care; treatment duration; treatment guidelines; vaginal microbiome; vaginal microbiota

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.

摘要 沙眼衣原体（CT）、淋病奈瑟菌（NG）和阴道毛滴虫（TV）感染 妊娠与胎膜早破、早产和分娩、低出生体重、 先天性感染、围产期死亡和母婴传播艾滋病毒感染。性传播 像这样的感染（STI）在全球孕妇中很常见，但往往未被诊断出来; 我们的研究小组发现，艾滋病毒感染孕妇中有41%的性传播感染，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的获得中发挥关键作用， 持久性和治疗结果。我们的试点工作已经表明，诊断测试的CT，NG，和电视， 在南非，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，我们的工作表明，评估不同诊断方法的影响和成本效益， 筛查策略，以最佳方式减少怀孕期间和分娩时的性传播感染负担， 迫切需要。此外，我们的研究结果强调，增加STI风险的生物因素 持久性和/或治疗失败必须进一步调查。 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，以减少 2）提供证据，以更新世卫组织的综合征 管理指南，3）阐明阴道微生物组在STI治疗结果中的作用，我们 提出一项具有以下三个目标的新颖、高度创新的研究： 目的1：评价3种不同筛查策略对降低孕妇CT/NG/TV负担的效果 减少不良生育后果。 目标2：评估每名孕妇接受筛查和治疗的成本，不良分娩结局的成本， 避免的每项性传播感染和残疾调整生命年的成本效益。 目的3：探讨阴道微生物组与持续性衣原体感染之间的关系 孕妇感染。 我们提出的5年研究将从三个大的艾滋病毒感染者和1250名未感染的孕妇中招募1250名， 南非Tshwane区的ANC诊所，以及他们的约2500名新生儿和多达834名男性伴侣。我们 研究团队由知名研究人员领导，在研究的各个方面都具有重要的专业知识和经验， 建议的研究。我们的多机构合作将使我们能够利用独特的实施平台 这将有助于南非和全球利益攸关方快速传播调查结果。