A Brief Prenatal Intervention of Behavioral Change to Reduce the Risk of Maternal Cytomegalovirus: A Randomized Controlled Trial

Abstract

Objective: To estimate the effects of a brief prenatal behavioral intervention on risk behaviors for maternal cytomegalovirus (CMV) infection.

Methods: Women were screened with CMV serology during prenatal care before 20 weeks of gestation and followed for at least 10 weeks. Women without serologic evidence of primary CMV infection were approached. Participants were apprised of serostatus and then randomized 2:1 to either a brief behavioral intervention during their prenatal care visit or to standard care (a brochure). The 7- to 10-minute in-office intervention included a video and hygiene education using motivational interviewing. Participants were then given a reminder calendar to take home and weekly text message reminders. The primary outcome was change in behavioral compliance score on a scale of 0-100. Secondary outcomes included process evaluation and domains of behavior change. A sample size of 180 participants was planned to compare the behavioral compliance score change of at least 15% between intervention and control groups with 80% power and 2.5% two-sided α.

Results: From April 2013 to October 2014, 197 women were randomized. One hundred eighty-seven (96%) had outcome data available. Mean gestational age at screening and randomization was 9 4/7 and 13 6/7 weeks of gestation, respectively. Primary outcome assessment occurred at a mean of 28 4/7 weeks of gestation. Baseline behavioral compliance scores increased modestly in the intervention group (mean: 7-point increase from 80.7 to 87.7, 95% CI 2.4-5.9) compared with the comparison group (mean: 4-point increase from 79.7 to 84.1, 95% CI 5.9-8.4; mean difference in change score: 3.0, 95% CI, 0.8-5.2; P=.007). Those in the intervention group reported change in risk perception related to perceived severity and susceptibility, self-efficacy, and perceived norms (P<.05 for all).

Conclusion: A brief behavioral intervention delivered in the prenatal care setting was modestly effective at changing behaviors related to CMV infection risk.

Clinical trial registration: ClinicalTrials.gov, NCT01819519.