Actively Recruiting
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
Led by University of Massachusetts, Worcester · Updated on 2024-07-26
100
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
U
University of Massachusetts, Worcester
Lead Sponsor
M
ModernaTX, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how common cytomegalovirus (CMV) shedding is among young children up to 36 months old attending large group childcare centers and the staff who work regularly at these centers. This observational study aims to understand CMV transmission in early education and care settings and to develop infrastructure such as community engagement, data management, digital platforms, and sampling workflows to support future study stages. Participants include children up to 36 months of age and staff members who work regularly at these childcare centers. Each participant will complete a health survey and provide one saliva sample for CMV PCR testing to detect viral shedding. The study also pilots home sample collection to prepare for broader research efforts. During the study, participants will provide saliva samples and complete health surveys. Researchers will measure the prevalence of CMV shedding based on saliva PCR results. The study runs until the end of 2027 and involves building data pipelines and participant networks. This initial stage informs the design of subsequent research phases to better understand CMV transmission and immune responses.
CONDITIONS
Brief Title
Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children up to and including 36 months old at time of consent, regardless of attendance duration at the center
- Parent(s) must provide written informed consent for the child to be screened by saliva PCR collected at the center or at home
- Individuals who regularly work inside the center at least 5 days per year in any role, including employed, contracted, volunteer, full or part time
- Staff members must provide written informed consent to be screened by saliva PCR collected at the center or at home
You will not qualify if you...
- Children aged 37 months or older
- Children in custody of the State Department of Children and Families (DCF)
- Staff who do not regularly work inside the center (less than 5 days per year)
- Staff whose work is associated with but not regularly inside the center (e.g., bus drivers or food delivery staff)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants provide saliva samples to measure CMV shedding using PCR testing.
Regular saliva sample collection visits at the center or at home
Trial Site Locations
Total: 1 location
1
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
Research Team
L
Laura Gibson, MD
K
Karen Del'Olio, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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