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

基本信息

批准号：
10612875
负责人：
KAREN B FOWLER
金额：
$ 59.42万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
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/10612875
关键词：
Adherence Age 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 Education Electronic Mail Enrollment Ethnic Origin Ethnic Population 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 Text Third Pregnancy Trimester Umbilical Cord Blood Urine Vaccination Vagina Variant Viral Load result Virus Virus Shedding Visit Woman acceptability and feasibility behavior change cohort college congenital cytomegalovirus disability efficacy evaluation evidence base follow-up group intervention high risk indexing infection rate infection risk innovation next generation sequencing offspring post intervention prenatal prenatal health prevent primary outcome protective behavior psychosocial racial population randomized, controlled study recruit response sample collection screening secondary endpoint seroconversion seropositive skills stress reduction theories transmission process trial enrollment vaccine development viral DNA

项目摘要

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.

这项研究的长期目标是通过有效的方法减少先天性巨细胞病毒（cCMV）感染产前 CMV 风险降低干预可减少孕期母体 CMV 感染，从而减少破坏性的先天性巨细胞病毒感染。该研究将评估我们之前成功的效果简短的基于产前临床、理论指导的 CMV 风险降低行为干预，以预防孕产妇 CMV 经常接触 CMV 且其婴儿的年轻高危妇女在怀孕期间感染先天性 CMV 感染的风险增加。年轻孕妇将被招募到 CMV 认知- 第一次产前检查后的行为干预试验。注册后，他们将被随机分配到 CMV 风险降低干预或注意力匹配控制压力降低干预分层他们的 CMV 血清状态。两组女性都将参加个性化的行为技能课程，观看短片视频、接收带回家的数据包、每周接收短信/电子邮件，持续 12 周，以强化实验和对照干预措施，并在第 6 周和第 12 周进行随访。唾液、尿液、阴道和血液样本将在登记和随访时采集。此外，在家中唾液和阴道样本采集将在第 3 周和第 9 周进行，并且在妊娠晚期也会进行一次。在分娩时，将从母亲和婴儿身上采集唾液样本以及残余脐带血标本。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 风险降低的 CMV 血清免疫女性的再感染干涉。次要终点是 1) CMV 风险行为的减少和保护行为的增加通过问卷自我报告表明； 2) 出生后 21 天内确诊患有 cCMV 的婴儿比例生活; 3) 通过唾液、尿液、阴道或血液中的 CMV DNA 通过 PCR 检测 CMV 脱落和 CMV 病毒载量标本； 4）新的CMV变种； 5）通过心理社会量表测量的焦虑/压力水平； 6) 措施干预措施的依从性和可接受性； 7) 问卷显示的CMV知识变化；和 8) 孕期母体巨细胞病毒感染的危险因素（年龄、种族/民族、接触/行为相关对于幼儿，性活动指数）。结果将通过干预前和干预后 CMV 进行评估两个干预组的危险行为问卷。可能的 CMV 暴露将由以下人员评估每次访问时的调查问卷以及将为所有妇女获取的产前医疗记录。巨细胞病毒初级感染、CMV 再次感染、CMV 病毒脱落和病毒载量将通过 IgG、IgM 和亲和力进行评估检测、血清毒株特异性检测、下一代病毒 DNA 测序以及针对女性的 PCR 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 CMV 风险降低咨询可以减少母体 CMV 感染，从而也降低其后代的 cCMV 感染率。