ANN ARBOR, Mich.–(BUSINESS WIRE)–CareEvolution is excited to announce that enrollment through its clinical research platform, MyDataHelps, has opened for a groundbreaking study on cytomegalovirus (CMV) transmission within childcare settings to meet participants in their existing day-to-day environments. The CMV Transmission and Immune Tracking (CMV TransmIT) study is a collaborative effort between UMass Chan Medical School and Moderna.
Unique in its approach, this study pioneers a digital approach that easily handles the intricacies of consent/assent processes for pediatric and caregiver enrollment. Pediatric populations require special considerations when enrolling in clinical trials. While traditional methods for recruitment tend to focus on surrounding patient populations, CMV TransmIT implemented a unique outreach strategy by partnering with child care centers and educational institutions combined with the ease of digital enrollment.
Though CMV is common and usually causes mild or no symptoms in adults, 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. Studies focused on understanding how disease spreads from one person to another are inherently challenging. CMV TransmIT was designed with this in mind, ensuring that CMV testing occurs longitudinally for not only children, but also their household members and staff at the daycare centers.
CareEvolution’s MyDataHelps platform is the unified digital clinical trial platform powering the study and providing a streamlined experience for participants as well as the study team. Breaking away from convention, this research innovatively recruits directly from child care centers, bypassing traditional CROs and health system. The web-based app experience 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, shared, “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. 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. All of this leads to better understanding of the virus and its transmission and gives us better data for assessing and reducing risk down the road.”
Thejas Suvarna, the project lead added that, “Managing coordination of study activities for participants across multiple sites was challenging to achieve without a digital approach. We were able to seamlessly support enrollment, consent, surveys, sample collection, and other study tasks all within a singular digital ecosystem.”
Enrollment of group childcare and early childhood education settings in Worcester and Cambridge is ongoing. The study is led by Laura Gibson, MD, associate professor of medicine at UMass Chan. Dr. Gibson has extensive expertise in congenital CMV infection, including studies of T-cell responses to CMV in children. For more information about the study and how to enroll visit https://www.cmvtransmitstudy.com.
CareEvolution is a healthcare technology company raising the world’s standard for health by creating tools that connect disparate parts of the system and bring dimension to healthcare data. By connecting care delivery with clinical research, and liberating siloed data to make it useful, CareEvolution empowers healthcare researchers, payers, providers, public health, and builders to move at the speed of their ideas.