Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus (CDC/CMV)

Development and Evaluation of a Clinic-Based Screening and Brief Intervention for Changing Behaviors Related to Cytomegalovirus Transmission in Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Cytomegalovirus Infections; Behavior
• Intervention / Treatment: Behavioral: Educational Intervention

Detailed Description

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.

Both groups will be assessed for performance of hygiene behaviors as a baseline assessment at the time of consent. A second assessment will occur at least 12 weeks after enrollment during the third trimester between 28-36 weeks of gestation. The follow-up assessment will be completed by a different research assistant from the unblinded educator. A Kessler 10 (K10) survey will also be completed in addition to the baseline and follow-up assessment.

The follow-up assessment will take place during the participant's third trimester between 28-36 weeks of gestation, depending on duration of enrollment and likelihood of early delivery. The enrollment duration will vary from approximately 14-20 weeks.

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard Prenatal Care; Participants will receive standard prenatal care from the time they are screened for CMV to delivery. This includes a CMV brochure.
EXPERIMENTAL: Educational Intervention; This group will be approached during a routine prenatal visit and will receive a 5-10 minute educational intervention (CMV prevention video, preventive information, weekly text messages/emails as reminders for hygiene behaviors, developmental calendar with hygiene reminders).	Behavioral: Educational Intervention; The patient will told if previously infected or seronegative and what is the risk of the becoming infected. The research assistant will deliver a 5-10 minutes educational intervention, which will consist of a CMV video and some Q&A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hygiene Behaviors	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).	Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior Change based on Serostatus	Did knowing the serostatus affect hygiene behavior change, as defined by a change in compliance scores between baseline and follow-up visits?	Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Change in K10 after Intervention	Was there a change in stress and anxiety (measured by the K10 assessment scores) before and after the intervention?	Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Behavior Change based on Socioeconomics	Was behavior change influenced by socioeconomic status? Behavior change is defined by the difference in compliance scores between baseline and follow-up visits	Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Racial associations with hygiene behavior change	Was behavior change influenced by race? Behavior change is defined by the difference in compliance scores between baseline and follow-up visits	Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Behavior Change related to Children at home	Was behavior change influenced by the number of children living at home? Behavior change is defined by the difference in compliance scores between baseline and follow-up visits	Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)
Behavior Change and Occupation Association	Was behavior change influenced by participants' occupation? Behavior change is defined by the difference in compliance scores between baseline and follow-up visits	Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Brenna Anderson, MD, Women & Infants Hospital

Publications and helpful links

General Publications

• Hughes BL, Gans KM, Raker C, Hipolito ER, Rouse DJ. A Brief Prenatal Intervention of Behavioral Change to Reduce the Risk of Maternal Cytomegalovirus: A Randomized Controlled Trial. Obstet Gynecol. 2017 Oct;130(4):726-734. doi: 10.1097/AOG.0000000000002216.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (ESTIMATE): March 27, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Pregnancy; Cytomegalovirus Infections; Intervention studies
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: RFA-DD-12-005