UMass Chan Medical School and Moderna launch CMV TransmIT—a CareEvolution MyDataHelps-powered study for cytomegalovirus (CMV) transmission in the community
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ANN ARBOR, Mich. ~ A groundbreaking study on cytomegalovirus (CMV) transmission within childcare settings has opened enrollment through the clinical research platform, MyDataHelps. The CMV Transmission and Immune Tracking (CMV TransmIT) study is a collaborative effort between UMass Chan Medical School and Moderna.

This study pioneers a digital approach that easily handles the intricacies of consent/assent processes for pediatric and caregiver enrollment. It is unique in its approach as it focuses on outreach strategies by partnering with child care centers and educational institutions combined with the ease of digital enrollment.

CMV is common and usually causes mild or no symptoms in adults, but it is the most common infectious cause of birth defects in the world if spread from pregnant women to their children in utero (i.e., congenital CMV, cCMV). Pregnant people who are exposed to large groups of young children—like through childcare or preschools—are at high risk for CMV infection, and infants with cCMV are at risk for abnormal neurodevelopment, including hearing loss and microcephaly due to abnormal brain development. The CMV TransmIT study seeks to gain a detailed understanding of CMV transmission in group child care and early childhood education environments and the risk of spread within households—particularly to pregnant caretakers—with the aim of characterizing immune responses over time.

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CareEvolution's MyDataHelps platform is powering the study by providing a streamlined experience for participants as well as the study team. It begins with eligibility screening, ensuring that each participant fits the study's requirements. Additionally, through the platform, participants' guardians can eConsent, allowing permission to be granted quickly and easily to facilitate participation in the study. Once enrolled, the app is used for management of the participant's study experience through timely notifications and reminders for surveys and other study tasks.

Ed Ramos, PhD, Chief Scientific Officer of CareEvolution said "We are working to help reduce negative health outcomes for our most vulnerable population, children. CMV TransmIT is an important study for awareness and future reductions in viral spread." He added that "Our focus is to ensure we deliver a streamlined but meaningful experience to our study participants while prioritizing the ability to comprehensively collect relevant data."

Thejas Suvarna, project lead said that "Managing coordination of study activities for participants across multiple sites was challenging to achieve without a digital approach." He added that "We were able to seamlessly support enrollment, consent, surveys, sample collection, and other study tasks all within a singular digital ecosystem."

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Enrollment of group childcare and early childhood education settings in Worcester and Cambridge is ongoing under Dr Laura Gibson's leadership who has extensive expertise in congenital CMV infection including studies of T-cell responses to CMV in children. For more information about the study visit https://www.cmvtransmitstudy.com/.

The groundbreaking CMV TransmIT Study has opened enrollment through CareEvolution's MyDataHelps platform which provides a streamlined experience for participants as well as the research team while managing coordination across multiple sites within one digital ecosystem. The aim of this research is to gain an understanding of how disease spreads from one person to another by characterizing immune responses over time while reducing negative health outcomes among vulnerable populations such as children who are at high risk if exposed to large groups like those found in childcare or preschools settings due to their susceptibility towards congenital CMV infection which can lead abnormal neurodevelopment including hearing loss or microcephaly due abnormal brain development if spread from pregnant women during pregnancy .

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