PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - Randomized Controlled Trial (RCT)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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 clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. The proposed study includes the following a randomized controlled trial (RCT) that will assign adult parent/caregiver participants to a timeline for receiving intervention. This study will develop best practices, implementation guides, and dissemination of findings for other clinics to implement the program on a broader scale.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Parents/Caregivers (P/C) of children/adolescents (C/A) ages 9-17 years of age (i.e., age-eligible for HPV vaccination);

• P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 months); and

• P/C who speak either English or Spanish.

Locations
United States
Washington
Sea Mar Community Health Centers
RECRUITING
Seattle
Contact Information
Primary
Kaila Christini, MsPH, MS
Kaila.Christini@hci.utah.edu
801-587-4565
Backup
Research Assistant
Kepka-Research@hci.utah.edu
801-587-4565
Time Frame
Start Date: 2025-11
Estimated Completion Date: 2026-02
Participants
Target number of participants: 519
Treatments
Experimental: Automated Intervention (Auto)
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.
Experimental: Automated Intervention Plus (Auto-Plus)
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.
No_intervention: Usual Care (UC)
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.
Related Therapeutic Areas
Sponsors
Leads: University of Utah
Collaborators: University of Arizona, Sea Mar Community Health Centers, National Cancer Institute (NCI), Kaiser Permanente

This content was sourced from clinicaltrials.gov