Prenatal behavioral intervention to prevent maternal cytomegalovirus in pregnancy

这项研究的长期目标是通过一种有效的方法减少先天性巨细胞病毒(CCMV)的感染 减少孕期母体巨细胞病毒感染的产前巨细胞病毒风险干预，从而 减少破坏性的先天性巨细胞病毒感染。这项研究将评估我们之前成功的 以产前临床为基础、理论指导的巨细胞病毒降低风险行为干预预防母体巨细胞病毒 经常接触巨细胞病毒的年轻高危妇女及其婴儿孕期感染 先天性巨细胞病毒感染的风险增加。年轻的孕妇将被招募到CMV认知- 第一次产前探视后的行为干预试验。注册后，他们将被随机分配到 CMV风险减少干预或注意力匹配对照压力减少干预按以下分层 他们的巨细胞病毒血清状态。两组中的女性都将参加个性化的行为技能课程，观看一段简短的 视频，收到带回家的包裹，连续12周每周收到短信/电子邮件，以加强 实验和对照干预，并在6周和12周参加随访。唾液、尿液、阴道和 血液样本将在注册时和后续访问时收集。此外，在家中唾液和阴道 标本采集将在怀孕3周和9周进行，也在怀孕后期进行一次。在… 分娩时，将从母亲和婴儿身上采集唾液样本，以及残留的脐带血。 样本。初步研究结果包括：减少巨细胞病毒血清阴性妇女的原发感染 并减少随机接受CMV风险降低的血清免疫CMV妇女的再感染 干预。次要终点是1)减少CMV危险行为和增加保护行为 由问卷上的自我报告表示；2)在出生后21天内确诊的婴儿CCMV的比例 生命；3)唾液、尿液、阴道或血液中CMV DNA的聚合酶链式反应表明CMV的脱落和CMV病毒载量 样本；4)新的CMV变种；5)用心理社会量表测量焦虑/压力水平；6)测量 干预措施的依从性和可接受性；7)问卷显示CMV知识的变化；以及 8)孕期母亲感染巨细胞病毒的风险因素(年龄、种族/民族、接触情况/相关行为 对幼儿来说，性活动指数)。结果将通过干预前后的CMV进行评估 两个干预组均进行危险行为问卷调查。可能接触CMV的情况将通过以下方式进行评估 每一次访问时的问卷调查和所有妇女都将获得的产前医疗记录。CMV初级病毒 感染、CMV再感染、CMV病毒脱落和病毒载量将通过免疫球蛋白、免疫球蛋白M和亲和力进行评估 女性检测、血清学菌株特异性检测、新一代病毒DNA测序和聚合酶链式反应检测 在两个干预组中。这项随机对照试验的结果将为产前保健提供信息 通过提供证据表明为孕妇提供产前巨细胞病毒风险降低咨询可以减少 减少母体巨细胞病毒感染，从而也降低其后代的CCMV感染率。

The long-term goal of this research is to reduce congenital cytomegalovirus (cCMV) infections by an efficacious prenatal CMV risk-reduction intervention that reduces maternal CMV infections during pregnancy, thereby reducing damaging congenital CMV infection. The study will evaluate the efficacy of our previously successful brief prenatal clinic-based, theory guided CMV risk-reduction behavioral intervention to prevent maternal CMV infections during pregnancy in young high risk women who have frequent CMV exposures and whose infants are at increased risk of congenital CMV infections. Young pregnant women will be recruited into a CMV cognitive- behavioral intervention trial following their first prenatal visit. After enrollment, they will be randomized to either the CMV risk-reduction intervention or an attention-matched control stress-reduction intervention stratified by their CMV serostatus. Women in both groups will attend an individualized behavioral skills session, watch a short video, receive a take home packet, receive weekly text/email messages for 12 weeks that reinforce the experimental and control interventions, and attend follow up visits at 6 and 12 weeks. Saliva, urine, vaginal, and blood specimens will be collected at enrollment and at follow up visits. Additionally, at home saliva and vaginal specimen collection will occur at 3 and 9 weeks, and also once during the third trimester of pregnancy. At delivery, a saliva specimen will be collected from both the mother and infant, along with a remnant cord blood specimen. The primary study outcomes include: reduction of primary infections in CMV seronegative women and reduction of reinfections in CMV seroimmune women who are randomized to the CMV risk-reduction intervention. Secondary endpoints are 1) the reduction of CMV risk behaviors and increased protective behaviors indicated by self-report on questionnaires; 2) proportion of infants with cCMV confirmed in the first 21 days of life; 3) CMV shedding and CMV viral load indicated by CMV DNA by PCR in saliva, urine, vaginal, or blood specimens; 4) new CMV variants; 5) anxiety/stress levels measured by psychosocial scales; 6) measures of adherence and acceptability of the intervention; 7) changes in CMV knowledge indicated by questionnaires; and 8) risk factors for maternal CMV infections during pregnancy (age, race/ethnicity, exposures/behaviors related to young children, sexual activity indices). Outcomes will be assessed through pre- and post-intervention CMV risk behaviors questionnaires in both intervention groups. Possible CMV exposures will be assessed by questionnaires at each visit and by prenatal medical records that will be obtained for all women. CMV primary infections, CMV reinfections, and CMV viral shedding and viral load will be assessed by IgG, IgM, and avidity assays, serologic strain-specific assays, next generation sequencing of viral DNA, and PCR assays for women in both intervention groups. The outcomes of this randomized controlled trial will inform prenatal health care decisions by providing evidence that prenatal CMV risk-reduction counseling for pregnant women can reduce maternal CMV infections, and thereby also lower the rate of cCMV infection in their offspring.