Development and Evaluation of a Clinic-Based Screening and Brief Intervention for Changing Behaviors Related to Cytomegalovirus Transmission in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 2
- 主要终点
- Change in Hygiene Behaviors
研究概览
简要总结
The purpose of this study is to develop a brief screening and behavioral intervention for the prevention of congenital cytomegalovirus (CMV) that will both be acceptable to clinic staff and feasible to implement as part of routine clinical prenatal care, and to test whether behavioral intervention for susceptible pregnant women can lead to a behavioral change that is likely to lead to decreased primary CMV infection. The study research assistants will enroll pregnant women who are less than 20 weeks' gestation, either English or Spanish-speaking and that do not have a primary CMV infection (never been infected or previously infected). Enrollment will occur during the woman's prenatal visit.
详细描述
The study is a randomized single-masked clinical trial of behavioral intervention versus standard care of pregnant women lacking evidence of acute CMV infection that have consented to be screened as part of the Maternal Fetal Medicine Units Network multi-centered randomized clinical trial, in which pregnant women are screened with CMV serology for IgM, IgG, and IgG avidity.
Eligible pregnant women will be randomized to one of two treatment groups:
- Control Group - no intervention
- Intervention Group - brief intervention and educational materials Written informed consent will be obtained from patients before they can be screened for the study by CMV testing (IgM, IgG, and IgG avidity) as per the protocol for screening in the MFMU study.
All women presenting for prenatal care no later than 20 weeks gestational age without a known multifetal gestation are eligible for CMV screening Those with evidence of primary infection will be offered participation in the MFMU randomized trial of CMV hyperimmune globulin to prevent congenital infection. Women lacking evidence of acute infection will be eligible for randomization into this study. Patients must be randomized no later than 20 weeks gestation.
If eligible and no more than 20 weeks gestation, the patient will be randomized. If the patient is randomized in the control group, she will continue her routine prenatal care inclusive of the CDC brochure that she received at the time of her venipuncture for serologic screening and assessment of hygiene behaviors. If the patient is randomized into the intervention group, we will deliver a face-face educational intervention during her next routine prenatal visit. In addition to the intervention, the patient will include educational material to take home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women lacking evidence of acute CMV infection is defined as one of the following: A negative IgM antibody (<1.00 Index) and negative IgG antibody (<6.0 AU/ml) or A negative IgM antibody (<1.00 Index) and positive IgG antibody (≥6.0 AU/ml)
- •Gestational age during CMV screening will be no later than 20 weeks based on clinical information and evaluation of the earliest ultrasound.
- •Enrollment will occur no later than 20 weeks' gestation.
- •Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 20 weeks' by project gestational age is acceptable.
- •English and Spanish-speaking women of any age will be offered enrollment
排除标准
- •Planned termination of pregnancy
- •Women with a previous child with congenital CMV
- •Intention of leaving the prenatal practice
- •Known major fetal anomalies or demise
- •Multiple gestation
- •Known HIV infection
- •Primary CMV infection, as determined by a positive IgM antibody, a positive IgG antibody and low IgG avidity or positive IgM antibody and negative IgG antibody
- •An old and a recent CMV infection, as determined by a positive IgM antibody, positive IgG antibody and high IgG avidity.
- •Non-Spanish or English speaking
结局指标
主要结局
Change in Hygiene Behaviors
时间窗: Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
The primary outcome is defined as a change in the participant's hygiene behaviors determined by the differences between the baseline and follow-up behavioral assessment compliance scores. Each question in these assessments will be assigned a score from 0-5 (5 = desired preventative behavior).
次要结局
- Behavior Change based on Serostatus(Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up))
- Racial associations with hygiene behavior change(Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up))
- Behavior Change based on Socioeconomics(Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up))
- Behavior Change and Occupation Association(Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up))
- Change in K10 after Intervention(Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up))
- Behavior Change related to Children at home(Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up))
研究者
Brenna Hughes
Principal Investigator
Women and Infants Hospital of Rhode Island