At a glance
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PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - Randomized Controlled Trial (RCT)
In Brief
A Phase 3 clinical trial evaluating PREVENT for HPV Vaccination and 2 related conditions. Active but no longer recruiting, targeting 1,455 participants across 1 site.
Signals
Detailed Summary
This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States. The proposed study will assess the effectiveness of a clinic-based behavioral outreach intervention to increase HPV vaccination rates at community clinics in rural counties. The intervention consists of communication and engagement strategies delivered within routine care settings and is designed to pose no more than minimal risk to participants.
Study Details
Timeline
Arms & Interventions
Auto intervention participants will be eligible for outreach delivered using automated phone calls, text, or email messages with the mode, frequency, timing of reminders, and message content. Automated outreach may also include innovative communication strategies, such as text-linked videos, P/C, or patient narratives. Auto outreach to P/C will invite P/Cs to attend free HPV vaccination visits and emphasize family-friendly hours.
Auto-Plus intervention participants will be eligible for automated reminders, plus additional P/C prompts for patients who do not undergo vaccination within three weeks. These prompts may be delivered via live phone call outreach or patient navigation. Working with clinic leadership and previous research, activities will be selected from a list of possible options from the National HPV Vaccination Roundtable (previously chaired by Dr. Brewer) and our ranking of the effectiveness of language- and culturally- tailored intervention materials.
The UC group will not receive tailored reminders but will only receive opportunistic vaccine reminders that are delivered during clinic visits or MyChart EHR-based patient portal reminders.
Interventions
The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at community clinics in rural counties.