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

University of Massachusetts, Worcester

Status: Enrolling

Conditions: Cytomegalovirus Infections

Treatments: Diagnostic Test: CMV PCR on saliva

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06522880

IRB 00000521

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 day to 36 months old

Volunteers: No Healthy Volunteers

Inclusion and 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)

Trial design

100 participants in 2 patient groups

Children

Description:

Children up to and including 36 months in large group childcare centers in the study network

Treatment:

Diagnostic Test: CMV PCR on saliva

Staff

Description:

All staff members in large group childcare centers attended by children participants

Treatment:

Diagnostic Test: CMV PCR on saliva