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Purpose

The goal of STAGE I of the CMV TransmIT Study is to determine the prevalence of CMV shedding in children up to and including 36 months of age in large group childcare centers and in staff who regularly work at the center. Participants will complete a health survey and provide one saliva sample for CMV PCR testing. In addition, infrastructure for the study will be developed (e.g. community engagement to build the network of centers, data pipelines, digital platform, sampling workflows) and participant sample collection at home will be piloted. These activities will inform the design of STAGE II.

Condition

Eligibility

Eligible Ages
Between 1 Day and 36 Months
Eligible Sex
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Study Type
Observational
Observational Model
Ecologic or Community
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
Children Children up to and including 36 months in large group childcare centers in the study network
  • Diagnostic Test: CMV PCR on saliva
    Observational study to measure prevalence of CMV shedding by saliva PCR
Staff All staff members in large group childcare centers attended by children participants
  • Diagnostic Test: CMV PCR on saliva
    Observational study to measure prevalence of CMV shedding by saliva PCR

Recruiting Locations

UMass Chan Medical School
Worcester, Massachusetts 01655

More Details

Status
Recruiting
Sponsor
University of Massachusetts, Worcester

Study Contact

Laura Gibson, MD
5089813660
laura.gibson@umassmed.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.