The rural adolescent vaccine enterprise (RAVE): a cluster-randomized trial testing a multicomponent intervention to improve HPV vaccination in rural primary care settings

Human papillomavirus (HPV) vaccination prevents cancer, but rural U.S. adolescents are under vaccinated. We developed, tailored, and implemented, a multicomponent clinic-level HPV vaccination intervention for rural primary care clinics in Oregon. This manuscript describes the project implementation and the impacts on HPV vaccination and quality improvement infrastructure. The Rural Adolescent Vaccine Enterprise (RAVE) was a five-year stepped-wedge cluster-randomized trial conducted through the Oregon Rural Practice-based Research Network. Participating clinics received an intervention consisting of 18-months of practice facilitation supporting clinic-tailored HPV vaccination improvement. Clinics selected evidence-based HPV vaccination improvement activities based on local needs (e.g., reminder recall, HPV vaccination at age 9, staff education, workflow adaptation, and data system improvement). Primary outcomes were clinic-level rate of HPV vaccine initiation (≥ 1 dose) and completion among adolescents, age 11–17. Mixed-effects Poisson regression assessed changes in vaccination over time. Quality improvement (QI) infrastructure was measured pre- and post-intervention using the Quality Improvement Change Assessment (QICA) tool. Of 45 enrolled clinics, 36 (80%) completed the intervention. Most clinics focused on HPV vaccination series completion (72%) and utilized multiple strategies for HPV vaccination improvement. Overall HPV vaccination rates increased during the study (initiation: +0.5%/quarter; completion: +1.4%/quarter; both p < 0.001), but there was no additional effect attributable to the intervention (e.g., initiation IRR: 1.000; 95% CI: 0.985–1.015). Quality improvement capacity improved significantly, with an average QICA score increase of + 1.19 (95% CI: 0.80–1.59; p < 0.01), with the largest gains in care coordination. This tailored multicomponent intervention did not produce significant improvements in HPV vaccination, though participating clinics did see improvement in HPV vaccination rates over time. These outcomes may have been impacted by pandemic-related disruptions and variability in intervention implementation. Despite the challenging environment, clinic engagement in improving HPV vaccination remained high. Future supports are critically needed to help rural communities improve HPV vaccination. Future studies should prioritize interventions that bring higher intensity external support for busy and under-resourced primary care settings, should consider engaging multilevel community partners to support efforts outside of clinics, and should include longer post-intervention assessment of outcomes. ClinicalTrials.gov (NCT03604393), submitted 06/01/2019.