NCT06522880 · University of Massachusetts, Worcester
Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study
What this study is 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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
CMV PCR on saliva
Observational study to measure prevalence of CMV shedding by saliva PCR
Primary outcome measures
Prevalence of CMV shedding
Time frame: Stage I up to 2 years
Prevalence of CMV shedding in children and childcare center staff. Shedding measured by CMV PCR on saliva.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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
- Individuals who regularly (average \>/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time.
- Staff member has provided written informed consent to be screened for CMV by saliva PCR collected at the center or at home
Exclusion criteria
- \>/= 37 months of age
- State Department of Children and Families (DCF) custody Center Staff
- Do not regularly (average \< 5 days per year) work inside the center
- Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)
Where
- Worcester, Massachusetts
Collaborators
ModernaTX, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 26, 2024 · Source of record for eligibility and locations