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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD098352 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMV Risk-Reduction Intervention | Experimental | One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages |
|
| Stress Reduction Messaging | Placebo Comparator | One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMV Risk-Reduction Intervention | Behavioral | CMV Risk-Reduction Intervention |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen B Fowler | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
Requests for data sharing may be considered on a case-by-case basis.
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Laboratory personnel will not know the participant's intervention status.
| Stress Reduction Messaging | Behavioral | Stress Reduction Messaging |
|
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 |
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) |