Enhancing HPV Vaccine Initiation and Completion Through Primary Care Interventions: A Cluster-Randomized Trial

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Abstract Background Despite proven efficacy in cancer prevention, Human papillomavirus (HPV) vaccination rates remain suboptimal in the United States. While primary care pediatric practices are critical settings for vaccine delivery, various factors are known including provider practices and attitudes, parental hesitancy, and logistical barriers, contribute to low uptake. This study aims to evaluate the effectiveness of a community-based intervention designed to improve HPV vaccine initiation and series completion among adolescents aged 9–12 years in the states of Georgia and Tennessee. The intervention will include staff training, the introduction and provision of tailored vaccine promotion materials, and the deployment of a tablet-based educational app for parents. Methods This study is designed as a cluster-randomized controlled trial involving 36 pediatric practices (18 each in Georgia and Tennessee). Practices will be randomly assigned to one of three arms: two interventions (clinical and non-clinical) and one control arm. The primary outcome of interest is the initiation and completion of the HPV vaccine series by age 13, with a target of a 10% increase in vaccination rates compared to the control group. Secondarily, a reduction in missed opportunities for HPV vaccination during routine healthcare visits will be evaluated. Data will be collected from electronic medical records and state immunization registries. While we expect a direct comparison of rates in the intervention groups relative to the control group, multivariable regression will be utilized as needed to account for clinic-level clustering and key covariates. Results The study will enroll approximately 1,800 adolescents, split between states and practices, with accrual monitored to ensure balanced representation. Data on HPV vaccine initiation, completion, and missed opportunities will be analyzed to identify differences between the intervention and control groups. Each intervention arm will be compared to the control arm independently, and analysis will be conducted separately for HPV vaccine series initiation and completion. The results will determine intervention effectiveness in increasing HPV vaccination uptake and reducing missed opportunities within the context of routine pediatric care. Conclusions This study will offer critical insights into the effectiveness of a multi-component intervention designed to increase HPV vaccination rates in primary care settings. Additionally, findings will highlight key barriers and facilitators to vaccine delivery in pediatric practices, informing future efforts to improve HPV vaccination coverage. If successful, the intervention could serve as a scalable model for boosting vaccine uptake in other regions, contributing to the reduction of HPV-related cancers in the United States.

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