Pilot Study of STI Screening and Treatment for PMTCT

 描述（由申请人提供）：拟议的研究将有助于填补关键的空白，了解细菌性性传播感染如何影响母婴传播（MTCT）的艾滋病毒感染和婴儿的发病率和死亡率在时代的组合抗逆转录病毒治疗孕妇。我们提出了一项研究，以调查淋球菌（NG）和沙眼衣原体（CT）感染的筛查，以及筛查计划对艾滋病毒感染的母婴传播的潜在影响。我们小组最近的研究，包括在南非的研究，表明NG和CT感染使母婴传播艾滋病毒的风险增加了一倍。据估计，南非的早产率为每100例活产8例，每年造成8万多例早产，婴儿死亡率约为60%。南非是世界上每年分娩的艾滋病毒感染孕妇人数最多的国家之一（> 30万），不良的分娩结果和艾滋病毒母婴传播都是重大的公共卫生问题;尽管如此，很少有研究系统地衡量性传播感染和不良的分娩结果在感染艾滋病毒的南非妇女中的作用。我们的建议有两个具体目标。目标1：我们将确定在首次产前保健访视时筛查和治疗感染艾滋病毒的孕妇的NG和CT的可接受性和可行性，以便：a）确定同意接受检测的合格妇女的比例（可接受性）和在样本采集后两周内接受治疗的NG/CT感染女性（可行性），B）估计南非Tshwane区感染HIV的孕妇中CT和NG的患病率;和c）检查研究中孕妇中CT和/或NG感染与CT/NG治疗结果的相关性。目标二：我们将描述接受CT和NG筛查的HIV感染孕妇的纵向出生和婴儿结局，以便：a）估计不良出生结局的频率及其与CT和NG筛查和治疗的相关性;和B）估计HIV MTCT的频率及其与CT和NG筛查和治疗的相关性。这项试点研究旨在确定对感染艾滋病毒的孕妇进行CT/NG筛查和治疗的可行性和可接受性，包括治疗伴侣以防止再次感染。它有可能为旨在预防的计划提供重要信息， 这将有助于在南非预防艾滋病毒母婴传播，并直接影响低收入和中等收入国家与母婴健康有关的临床和公共卫生做法，特别是与细菌性性传播感染有关的做法。

 DESCRIPTION (provided by applicant): The proposed study will help fill critical gaps in the understanding of how bacterial STIs may impact mother-to-child-transmission (MTCT) of HIV infection and infant morbidity and mortality in the era of combination antiretroviral therapy in pregnant women. We propose a study to investigate screening for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) infections, and the potential impact of a screening program on the MTCT of HIV infection. Recent research by our group, including in South Africa, has demonstrated that NG and CT infections doubled the risk of mother-to-child HIV transmission. South Africa's estimated preterm delivery rate of 8 per 100 live-births results in more than 80,000 preterm births annually, associated with about 60% infant mortality. With one of the largest numbers of HIV-infected pregnant women delivering annually in the world (>300,000), both adverse birth outcomes and HIV MTCT are significant public health problems; despite this, few studies have systematically measured the role of STIs and adverse birth outcomes in HIV-infected South African women. There are two specific aims to our proposal. Aim 1: We will determine the acceptability and feasibility of screening and treating HIV-infected pregnant women for NG and CT at first antenatal care visit, in order to: a) determine the proportion of eligible women consenting to testing (acceptability) and NG/CT-infected women receiving treatment within two weeks of specimen collection (feasibility), b) estimate the prevalence of CT and NG in HIV-infected pregnant women in Tshwane District, South Africa; and c) examine correlates of CT and/or NG infection and CT/NG treatment outcomes among pregnant women in the study. Aim 2: We will describe longitudinal birth and infant outcomes for HIV-infected pregnant women screened for CT and NG, in order to: a) estimate the frequency of adverse birth outcomes and their association with CT and NG screening and treatment; and b) estimate the frequency of HIV MTCT and its association with CT and NG screening and treatment. This pilot study is designed to determine the feasibility and acceptability of routinizing CT/NG screening and treatment of HIV-infected pregnant women, including treatment of partners to prevent re-infection. It has the potential to significantly inform programs aimed at the prevention of HIV MTCT in South Africa and to directly impact clinical and public health practices in low and middle-income countries relating to maternal-child health, especially relating to bacterial STIs.