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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-10

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cytomegalovirus Infections

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children

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

CMV PCR on saliva

Intervention Type DIAGNOSTIC_TEST

Observational study to measure prevalence of CMV shedding by saliva PCR

Staff

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

CMV PCR on saliva

Intervention Type DIAGNOSTIC_TEST

Observational study to measure prevalence of CMV shedding by saliva PCR

Interventions

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CMV PCR on saliva

Observational study to measure prevalence of CMV shedding by saliva PCR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

1 Day

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No