Clinical Trial: Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 ad
Sponsor: Women and Infants Hospital of Rhode Island

Current Primary Outcome: Change in Hygiene Behaviors [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Women and Infants Hospital of Rhode Island

Dates:
Date Received: March 18, 2013
Date Started: March 2013
Date Completion:
Last Updated: June 1, 2015
Last Verified: June 2015