hildren of low-income and minority families have high prevalence of early childhood caries. Since they havemuch better access to medical care and social services than to dental care, we propose to implement aprogram to apply fluoride varnish (FV), a low cost, low tech caries prevention agent, to the teeth of lowncome1-3 year olds in community-based primary care centers (CPCCs) and in California SpecialSupplemental Nutrition Programs for Women, Infants and Children (WIC). We will use a stratified 2x2factorial (4-arm) cluster-randomized controlled practical clinical trial of 48 sites testing: (1) FV delivery on-site(OSFV) or referring to a dentist for FV (RFV) and (2) telephone counseling systems (proactive outgoing callsor passive receptive toll-free calls) on caries incidence and increment, and on reach of FV preventivetreatment in 1-3 year olds. Strata are CPCC or WICs. Six consenting sites will be enrolled in each stratumin each of Years 1-4 for a total of 24 sites/stratum. Sites within each stratum will be randomly assignedeither to the OSFV or the RFV Group. Sites within each Group will be randomly assigned either to aproactive or passive automated telephone format for the provision of culturally sensitive, linguisticallyconcordant caregiver counseling for the prevention of ECC. A sub-sample of 60 consenting child-caregiverdyads will be recruited from each site in all 4 arms of each stratum. The 1-3 year old child will receive abaseline and12-mo follow-up clinical dental exam. Digital images of all teeth will be transmitted off site forassessment by a calibrated dentist blinded to group assignment to determine caries. At 12 mo postbaseline,providers at each site will complete a follow-up questionnaire and a random sample of allcaregivers of eligible 1-3 year olds from each site will receive follow-up automated phone callsand todetermine if their child received FV. After the 12 mo follow-up, the sites assigned to the RFV group will beoffered training to switch to an OSFV group. All groups will be followed for another 6 mo to assess reachand sustainability under more real world conditions. In year 5, Year 1 sites will be evaluated for programsustainability using qualitative interview measures. Sites in each arm within and between strata will becompared for reach of FV exposure among all eligible 1-3 year olds, for caregiver engagement with thecounseling formats, and for program adoption, fidelity, cost, and sustainability across client populations.
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