HPV Ends Here: Increasing Uptake of the HPV Vaccine (HPV)

Human Papillomavirus Ends Here: A Multilevel Intervention to Increase Uptake of the HPV Vaccine Among Adolescents

Develop, implement, and evaluate a culturally tailored multilevel intervention to increase uptake of the HPV vaccine among eligible patients ages 10-12 of the University of California, Davis Health Community Physician (UCDH CP) primary care practices using a randomized controlled trial design.

Study Overview

• Status: Recruiting
• Conditions: HPV Vaccine
• Intervention / Treatment: Behavioral: Intervention Arm

Detailed Description

The goal of this study is to use an evidence-based approach to develop, implement and evaluate a ML intervention on increasing HPV vaccine uptake among UCDH CP patients ages 10-12.

Aim 1. Refine and finalize a parent, primary care team and clinic ML intervention to increase uptake and completion of the HPV vaccine series among adolescent patients of the UCDH CP practices. In Phase 1, semi-structured qualitative interviews with key stakeholders will be conducted to refine the content and implementation approaches.

Aim 2. Conduct and evaluate the effectiveness and sustainability of the ML intervention. In Phase 2, twelve UCDH CP practices will be recruited to participate in a 2-arm parallel group randomized controlled trial. The primary outcome age-appropriate completion of the HPV vaccine series will be assessed via Epic, the UCDHS electronic medical record (EMR) software. It is hypothesized that patients of clinics in the intervention condition will have significantly higher HPV completion rates compared to patients of clinics in the control condition (usual care).

• Study Type: Interventional
• Enrollment (Estimated): 2232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramneek Kahlon, BS; Phone Number: 9167312578; Email: rkahlon@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis Health
      • Contact: Julie HT Dang, PhD; Email: jtdang@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Clinic patients between the ages of 10-12 who are eligible for the HPV vaccine

Exclusion Criteria:

• Clinic patients who already received the HPV vaccine or with any contraindication to the HPV vaccine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; These clinics will not receive any intervention and will continue with care as usual.
Experimental: Intervention Arm; These clinics will receive the multilevel intervention which will include tailored parent/patient education, appointment scheduling assistance, and primary care team trainings.	Behavioral: Intervention Arm; Within the intervention clinics, parents of patients between the ages of 10-12 (who are eligible for the HPV vaccine) will receive a culturally tailored customized HPV vaccine message and testimonial video from a patient/survivor of an HPV associated cancer (e.g., oropharyngeal, or cervical) via the MyChart patient portal. Parents will also receive a personal call from the research coordinator to remind them that their child is due for the HPV vaccine. If the parent is interested in scheduling the HPV vaccine appointment during this call, the research coordinator will transfer the parent to UC Davis appointment call center to schedule the appointment. Also, primary care team members will receive a semi-annual learn at lunch workshop focused on strategies to introduce the HPV vaccine to parents and how to address concerns from vaccine hesitant parents. Workshop content will be tailored/adapted to include patient/parent cultural considerations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome: Evaluation	Number of participants who initiate and complete the HPV vaccine series	One year

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Julie HT Dang, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: HPV; Human Papillomavirus
• Other Study ID Numbers: 2179292-1; 1K01CA258956-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No