Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus

描述（由申请人提供）：由于在美国没有既定的预防先天性巨细胞病毒（CMV）感染的措施，因此目前的方法是随意和无效的。本申请的目的是开发一种简单的筛查和干预方法，该方法既可为诊所工作人员所接受，又可作为常规临床产前护理的一部分实施，并测试易感妇女的行为干预是否可以影响可能导致原发性CMV感染减少的行为改变。我们的中心假设是，有针对性的行为干预，利用健康信念， 行为改变模型，将导致可测量和持久的行为改变，可以降低母体CMV感染（和再感染）的风险。我们计划通过追求以下具体目标来客观地检验我们的假设。1.建立产前基于诊所的CMV筛查：作为我们正在进行的NICHD孕产妇胎儿医学单位网络预防CMV感染临床试验的一部分，我们将在罗得岛的几个地点建立基于诊所的筛查。使用中心实验室，我们将测量母体CMV IgG、IgM和IgG亲和力。识别有母体感染（或再感染）风险的妇女将使我们能够让她们参与本研究的随机试验部分，以评估行为干预对降低CMV风险行为的影响。2.评估提供筛查知识和简短的行为干预是否会影响降低风险的行为：使用行为改变的健康信念模型，我们将进行一项随机临床试验，其中一半的患者将接受筛查。 参与者将被分配到干预组，一半接受标准护理。在干预组，参与者将被告知他们的CMV血清状态，并将接受行为矫正培训，由非医生工作人员提供教育，并将接受视觉检查。 线索对照组将接受标准的临床护理和预防CMV感染的小册子。我们将测量各组之间与CMV感染相关的行为依从性。3.评估行为干预的可接受性、参与者相对于干预的压力/焦虑水平以及拉格量表干预推出的可行性和成功可能性：使用经验证的压力量表，我们将评估参与者对干预的可接受性。将在临床环境以及更大的卫生保健系统层面确定广泛计划的促进因素和障碍。这一贡献将是重要的，因为它将测试筛查和有针对性的干预是否是改变行为的有效方法，这可能导致先天感染CMV的婴儿数量显着下降。该项目具有创新性，因为它将是第一个在孕妇中进行的大规模随机CMV筛查和行为干预研究。

DESCRIPTION (provided by applicant): Because there are no established measures for prevention of congenital cytomegalovirus (CMV) infection in the United States, the current approach is haphazard and ineffective. The objective of this application is to develop a brief screening and intervention that will be both acceptable to clinic staff and feasible to implement as part of routine clinical prenatal care, and to test whether behavioral intervention for susceptible women can effect behavioral change that is likely to lead to decreased primary CMV infection. Our central hypothesis is that targeted behavioral intervention, using the health belief model of behavior change, will lead to a measurable and durable behavior change that could decrease the risk of maternal CMV infection (and re-infections). We plan to objectively test our hypothesis by pursuing the following specific aims. 1. Establish prenatal clinic-based CMV screening: As part of our ongoing NICHD Maternal Fetal Medicine Units Network clinical trial to prevent CMV infection, we will establish clinic-based screening in several sites in Rhode Island. Using a central laboratory, we will measure maternal CMV IgG, IgM, and IgG avidity. Identification of women at risk for maternal infection (or re-infection) will allow us to engage them in the randomized trial component of this study to estimate the effect of behavioral intervention on CMV risk-reduction behaviors. 2. Evaluate whether provision of screening knowledge and brief behavioral intervention will influence risk-reducing behavior: Using the health belief model of behavioral change, we will conduct a randomized clinical trial in which half the participants will be allocated to an intervention group and half to standard care. In the intervention group, participants will be informed of their CMV serostatus and will undergo behavior modification training, education delivered by non-physician staff, and will receive visual cues. The comparison group will receive standard clinical care and a brochure on prevention of CMV infection. We will measure compliance in behaviors relevant to CMV infection between the groups. 3. Assess the acceptability of behavior intervention, level of stress/anxiety perceived by the participant relative to the intervention, and the feasibility and likelihood of success of a lage scale intervention roll-out: Using a validated stress scale, we will assess participant acceptabiliy of the intervention. Facilitators of and barriers to a widespread program will be identified in clinical settings as well as at the level of the larger health care system. This contribution will e significant because it will test whether screening and targeted intervention are effective ways of changing behavior that could lead to a significant decline in the number of infants congenitally infected with CMV. This project is innovative because it will be the first large-scale, randomized CMV screening and behavioral intervention study undertaken in pregnant women.