Friday, January 21, 2022
1/21/2022
The long-term goal of this research is to reduce congenital cytomegalovirus (cCMV) infections by an efficacious prenatal CMV risk-reduction intervention that reduces maternal CMV infections during pregnancy, thereby reducing damaging congenital CMV infection. The study will evaluate the efficacy of our previously successful brief prenatal clinic-based, theory guided CMV risk-reduction behavioral intervention to prevent maternal CMV infections during pregnancy in young high risk women who have frequent CMV exposures and whose infants are at increased risk of congenital CMV infections. Young pregnant women will be recruited into a CMV cognitive- behavioral intervention trial 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 intervention 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/email messages for 12 weeks that reinforce the experimental and control interventions, and attend follow up visits at 6 and 12 weeks. Saliva, urine, vaginal, and blood specimens will be collected at enrollment and at follow up visits. Additionally, at home saliva and vaginal specimen collection will occur at 3 and 9 weeks, and also 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. The primary study outcomes include: reduction of primary infections in CMV seronegative women and reduction of reinfections in CMV seroimmune women who are randomized to the CMV risk-reduction intervention. Secondary endpoints are 1) the reduction of CMV risk behaviors and increased protective behaviors indicated by self-report on questionnaires; 2) proportion of infants with cCMV confirmed in the first 21 days of life; 3) CMV shedding and CMV viral load indicated by CMV DNA by PCR in saliva, urine, vaginal, or blood specimens; 4) new CMV variants; 5) anxiety/stress levels measured by psychosocial scales; 6) measures of adherence and acceptability of the intervention; 7) changes in CMV knowledge indicated by questionnaires; and 8) risk factors for maternal CMV infections during pregnancy (age, race/ethnicity, exposures/behaviors related to young children, sexual activity indices). Outcomes will be assessed through pre- and post-intervention CMV risk behaviors questionnaires in both intervention groups. Possible CMV exposures will be assessed by questionnaires at each visit and by prenatal medical records that will be obtained for all women. CMV primary infections, CMV reinfections, and CMV viral shedding and viral load will be assessed by IgG, IgM, and avidity assays, serologic strain-specific assays, next generation sequencing of viral DNA, and PCR assays for women in both intervention groups. The outcomes of this randomized controlled trial will inform prenatal health care decisions by providing evidence that prenatal CMV risk-reduction counseling for pregnant women can reduce maternal CMV infections, and thereby also lower the rate of cCMV infection in their offspring.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
