Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study

Last updated: July 25, 2024
Sponsor: University of Massachusetts, Worcester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cytomegalovirus Infections

Treatment

CMV PCR on saliva

Clinical Study ID

NCT06522880
IRB 00000521
  • Ages 1-36
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: CMV PCR on saliva
Phase:
Study Start date:
August 10, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • UMass Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

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