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

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.

Study Overview

• Status: Recruiting
• Conditions: Maternal Cytomegalovirus Infections; Cytomegalovirus Congenital
• Intervention / Treatment: Behavioral: CMV Risk-Reduction Intervention; Behavioral: Stress Reduction Messaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 840
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen B Fowler, DrPH; Phone Number: 205 638 2549; Email: kfowler@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama At Birmingham
      • Contact: Karen B Fowler, DrPH; Phone Number: 205-996-7791; Email: kfowler@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CMV viral loads	CMV viral loads indicated by the quantity of CMV DNA by PCR in saliva, urine, vaginal, or blood specimens.	Enrollment(baseline) until delivery, up to 32 weeks
Risk factors for CMV infections	Identification of possible CMV exposures during pregnancy through self-reported exposure questionnaires given at baseline, 6 weeks, and 12 weeks.	Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Change in anxiety after intervention	Changes in anxiety measured by the Kessler-10 Psychological Distress Scale (K10) administered pre- and post-intervention. K10 scores range from 10 to 50, with 50 indicating highest risk of anxiety.	Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Change in CMV knowledge	Change in CMV knowledge indicated by self-report on CMV knowledge questionnaire administered pre- and post-intervention to all participants. The questionnaire will be assigned a score of 0 -18 based on the participants' answers, with a higher score indicating desired CMV knowledge.	Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Acceptability of the educational intervention	Acceptability of prevention messages measured post-intervention by a study assessment questionnaire that provides participant feedback and rating of the intervention at 12 weeks.	Enrollment(baseline) to 12 weeks after enrollment (follow-up)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Karen B Fowler, University of Alabama At Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: IRB-300004979; R01HD098352 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Requests for data sharing may be considered on a case-by-case basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No