Tracking Cytomegalovirus in Children and Childcare Staff
Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study: An Observational Study to Evaluate CMV Transmission and Immune Correlates of Viral Shedding Among Young Children in Early Education and Care Settings
This study is trying to see how common cytomegalovirus is in young children and childcare staff by collecting saliva samples and health information.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 1 Day to 36 Months |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT06522880 on ClinicalTrials.gov |
What this trial studies
The CMV TransmIT Study aims to assess the prevalence of cytomegalovirus (CMV) shedding in children up to 36 months old and the staff at large group childcare centers. Participants will complete a health survey and provide a saliva sample for CMV PCR testing. The study will also develop infrastructure for community engagement and data collection, which will inform future stages of the research. This observational study focuses on understanding CMV transmission dynamics in childcare settings.
Who should consider this trial
Good fit: Ideal candidates include children up to 36 months of age attending childcare centers and staff members who work regularly at these centers.
Not a fit: Patients over 36 months of age or those in state custody will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of CMV transmission and inform strategies to reduce infections in vulnerable populations.
How similar studies have performed: While there have been studies on CMV, this specific approach focusing on childcare centers and community engagement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Children 1. All children up to and including 36 months at time of signed consent regardless of duration of attendance at the center. Children living in the same household can each be enrolled. 2. Parent(s) has provided written informed consent for the child to be screened for CMV by saliva PCR collected at the center or at home Center Staff 1. Individuals who regularly (average \>/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time. 2. Staff member has provided written informed consent to be screened for CMV by saliva PCR collected at the center or at home Exclusion Criteria Children 1. \>/= 37 months of age 2. State Department of Children and Families (DCF) custody Center Staff 1. Do not regularly (average \< 5 days per year) work inside the center 2. Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)
Where this trial is running
Worcester, Massachusetts
- UMass Chan Medical School — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Laura Gibson, MD — UMass Chan Medical School
- Study coordinator: Laura Gibson, MD
- Email: laura.gibson@umassmed.edu
- Phone: 5089813660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.