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: 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
• 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

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 在期间感染沙眼衣原体（CT），Neisseria Gonorrhoeae（NG）和Trichomonas阴道（电视） 怀孕与膜的过早破裂有关，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亲传播。性传播 像这样的感染（性传播感染）在全球孕妇中很常见，但经常被诊断出来。最近的工作 我们的小组发现感染HIV感染的孕妇患病率为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STI获取中起关键作用， 持久性和治疗结果。我们的飞行员工作表明，对CT，NG和TV的诊断测试 南非为艾滋病毒感染的孕妇提供的产前护理服务是高度可接受和可行的。 但是，我们的工作清楚地表明，评估不同诊断的影响和成本效益 筛查策略可最佳地减轻怀孕期间和交付时性传播感染负担 迫切需要。此外，我们的发现强调了增加STI风险的生物学因素 必须进一步研究持久性和/或治疗失败。 响应需要1）确定最佳，具有成本效益的筛选策略，以减轻 怀孕期间的性传播感染并减少不良出生结果，2）提供证据以更新谁的综合症 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 提出了一项新颖，高度创新的研究，以下三个目标： 目标1：评估3种不同的筛选策略，以减轻怀孕的CT/NG/TV负担 妇女，减少不良的出生结果。 AIM 2：评估每名孕妇筛查和治疗的费用，不良出生结果的成本，以及 避免了每SET的成本效益和残疾调整后的生活年度（DALY）。 目标3：研究阴道微生物组与持续性衣原体之间的关系 孕妇感染。 我们拟议的5年研究将招募1250名HIV感染和1250名未感染的孕妇，来自三个大型 南非Tshwane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 由成熟研究人员领导的研究团队在各个方面具有重要的专业知识和经验 拟议的研究。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发现。