Table 1.

PIVOT with MI trial specifications

Data category	Information
Registry and trial number	ClinicalTrials.gov: NCT03885232
Date of registration	21 March 2019
Secondary identifying numbers	17–1274
Financial support	Eunice Kennedy Shriver National Institute of Child Health and Development at the US National Institutes of Health; PO Box 3006, Rockville, MD 20847
Contact for queries	douglas.opel@seattlechildrens.org
Title	Evaluation of the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI) Intervention
Countries of recruitment	USA
Health condition studied	Infant vaccination
Intervention(s)	Active comparator: clinician vaccine communication strategy Passive comparator: usual care
Key inclusion and exclusion criteria	Inclusion: ≥18-year-old parent with child ≤2 months old who receives health supervision at participating practice. Exclusion: parent who is <18 years old or has child >2 months old who receives health supervision at a participating practice
Study type	Cluster randomised controlled trial
Date of first enrolment	27 September 2019
Target sample size	600 vaccine-hesitant parents
Trial status	Ongoing data collection
Primary outcomes	Percentage of days undervaccinated of child at 19 months of age
Key secondary outcomes	Parent visit experience; clinician self-efficacy; clinician adherence to PIVOT with MI communication strategies