Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

Study Overview
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Brief Summary
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This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.

Detailed Description
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Pregnant women will be recruited into the study 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 group 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 messages for 12 weeks that reinforce the experimental and control health messages, and attend follow-up visits at 6 and 12 weeks. Saliva, urine, vaginal, and blood specimens will be collected at enrollment and 6 and 12 weeks follow-up visits. Additionally, at-home saliva and vaginal specimen collection will occur at 3 and 9 weeks and 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.

Official Title
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Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

Conditions
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Maternal Cytomegalovirus Infections, Cytomegalovirus Congenital

Intervention / Treatment
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* Behavioral: CMV Risk-Reduction Intervention
* Behavioral: Stress Reduction Messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: enrollment in prenatal care before 20 weeks gestation absence of CMV IgG on serological testing indicating CMV seronegative status or CMV positive (nonprimary) defined as maternal CMV infection pre-dating pregnancy defined by a high IgG avidity index or a positive CMV IgG in the presence of a negative CMV immunoglobulin M (IgM) Exclusion Criteria: known major fetal anomalies or demise planned termination of pregnancy planned use of immune globulin, ganciclovir, or valganciclovir maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection medications) pre-enrollment ultrasound suggestive of established fetal CMV infection or positive fetal CMV results from culture or PCR pre-enrollment CMV seroconversion or primary CMV infection in pregnancy unable to determine if CMV infection is a nonprimary infection due to intermediate or undefined CMV serological test results pre-enrollment blood, ultrasound, or amniotic fluid testing indicating congenital infection with rubella, syphilis, varicella, parvovirus, toxoplasmosis or other congenital infection intention of the patient or of the managing obstetricians for the delivery to be outside of the University of Alabama at Birmingham hospital

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CMV Risk-Reduction Intervention<br>One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages | Behavioral: CMV Risk-Reduction Intervention<br>* CMV Risk-Reduction Intervention<br>|
| Placebo Comparator: Stress Reduction Messaging<br>One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages | Behavioral: Stress Reduction Messaging<br>* Stress Reduction Messaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV seroconversion rate in CMV seronegative women | CMV seroconversion is defined as the development of CMV immunoglobulin G (IgG) antibody in the serum of women who did not have antibodies previously. The CMV seroconversion rate will be assessed in participants. | Enrollment (baseline) until delivery, up to 32 weeks | 
| CMV reinfections in women with non-primary infections | Reinfection will be defined by a combination of strain-specific serologic assays, next-generation sequencing, and virus shedding. The number of CMV reinfections will be assessed in participants. | Enrollment(baseline) until delivery, up to 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported CMV risk behaviors and protective behaviors | Change in the CMV risk behaviors and protective behaviors self-reported on the CMV risk behaviors questionnaire at 12 weeks post intervention. | Enrollment (baseline) to 12 weeks after enrollment (follow-up) | 
| Frequency of CMV shedding | Number of participants shedding CMV in their specimens collected during pregnancy. CMV shedding is indicated by the presence of CMV DNA by polymerase chain reaction assay (PCR) in saliva, urine, vaginal, or blood specimens. | Enrollment(baseline) until delivery, up to 32 weeks | 
| Proportion of infants with congenital CMV | The proportion of infants with a positive saliva PCR test for CMV in the first 21 days of life. | Delivery | 
| Frequency of new CMV variants | Number of participants with new CMV variants identified by a combination of serological screening assays and next generation sequencing of viral DNA. | Enrollment(baseline) until delivery up to 32 weeks |