Prenatal behavioral intervention to prevent maternal cytomegalovirus in pregnancy

产前行为干预预防孕期母体巨细胞病毒

• 批准号: 10188581
• 负责人: KAREN B FOWLER
• 金额: $ 60.79万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-10 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10188581
• 关键词: Adherence; American; Anxiety; Attention; Avidity; Behavior; Behavior Therapy; Behavioral; Biological Assay; Blood specimen; Child; Clinic; Cognitive Therapy; Control Groups; Counseling; Cytomegalovirus; Cytomegalovirus Infections; DNA; Discipline of obstetrics; Dose; Electronic Mail; Enrollment; Ethnic Origin; Ethnic group; Exposure to; Family; Fetus; Friends; Goals; Gynecologist; Healthcare; High Risk Woman; Home; Hygiene; Immunoglobulin G; Immunoglobulin M; Infant; Infection; Intervention; Intervention Trial; Knowledge; Life; Maternal-Fetal Transmission; Measures; Medical Records; Mothers; Oral; Outcome; Outcome Study; Participant; Patient Self-Report; Population; Pregnancy; Pregnant Women; Prenatal care; Prevention; Primary Infection; Questionnaires; Race; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Risk Behaviors; Risk Factors; Risk Reduction; Risk Reduction Behavior; Saliva; Serology; Serology test; Sex Behavior; Source; Specimen; Stress; Suggestion; Text; Third Pregnancy Trimester; Umbilical Cord Blood; Urine; Vaccination; Vagina; Variant; Viral Load result; Virus; Virus Shedding; Visit; Woman; base; behavior change; cohort; college; congenital cytomegalovirus; disability; efficacy evaluation; evidence base; follow-up; group intervention; high risk; indexing; infection risk; innovation; next generation sequencing; offspring; post intervention; prenatal; prenatal health; prevent; primary outcome; protective behavior; psychosocial; racial and ethnic; randomized controlled study; recruit; response; sample collection; screening; secondary endpoint; seroconversion; seropositive; skills; stress reduction; theories; transmission process; vaccine development; viral DNA

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.

本研究的长期目标是通过有效的免疫治疗减少先天性巨细胞病毒（cCMV）感染。 产前CMV风险降低干预，减少孕妇在怀孕期间的CMV感染，从而 减少损害性的先天性CMV感染。这项研究将评估我们以前成功的 以产前门诊为基础，理论指导的降低巨细胞病毒风险行为干预预防孕产妇巨细胞病毒感染 经常接触CMV的年轻高危妇女和其婴儿在怀孕期间感染 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一个CMV认知- 行为干预试验后，他们的第一次产前访问。入组后，他们将被随机分配至 CMV风险降低干预或注意力匹配控制减压干预， 他们的CMV血清状态。两组的女性都将参加一个个性化的行为技能课程，观看一个简短的 视频，收到一个带回家的数据包，在12周内每周收到一次短信/电子邮件， 实验和对照干预，并参加6周和12周的随访。唾液，尿液，阴道，还有 将在入组和随访访视时采集血样。此外，在家里唾液和阴道 将在妊娠第3周和第9周采集标本，并在妊娠晚期采集一次。在 分娩时，将从母亲和婴儿身上收集唾液样本，沿着残留的脐带血 试样主要研究结果包括：减少CMV血清阴性女性的原发感染 并减少随机接受CMV风险降低治疗的CMV血清免疫女性的再感染 干预次要终点是1）CMV风险行为减少和保护行为增加 通过问卷上的自我报告表明; 2）在出生后前21天内确认患有cCMV的婴儿比例 3）通过PCR在唾液、尿液、阴道或血液中通过CMV DNA指示CMV脱落和CMV病毒载量 标本; 4）新的CMV变体; 5）通过心理社会量表测量的焦虑/压力水平; 6） 干预的依从性和可接受性; 7）问卷调查显示CMV知识的变化;以及 8)妊娠期间母体CMV感染的风险因素（年龄、人种/种族、暴露/行为相关 幼儿的性活动指数）。将通过干预前后的CMV评估结局 两个干预组的危险行为问卷。可能的CMV暴露将通过以下方式进行评估： 在每次访问时进行问卷调查，并通过产前医疗记录，将获得所有妇女。CMV原发性 将通过IgG、IgM和亲合力评估CMV感染、CMV再感染和CMV病毒脱落和病毒载量 检测、血清学菌株特异性检测、新一代病毒DNA测序和女性PCR检测 在两个干预组。这项随机对照试验的结果将为产前保健提供信息 通过提供证据证明孕妇产前CMV风险降低咨询可以减少 母亲CMV感染，从而也降低了其后代中cCMV感染的比率。