HPV Ends Here: Increasing Uptake of the HPV Vaccine

NCT ID: NCT06831929

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-12-31

Brief Summary

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.

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).

Conditions

HPV Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Arm

These clinics will not receive any intervention and will continue with care as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

These clinics will receive the multilevel intervention which will include tailored parent/patient education, appointment scheduling assistance, and primary care team trainings.

Group Type: EXPERIMENTAL

Intervention Arm

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie HT Dang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Health

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ramneek Kahlon, BS

Role: CONTACT

rkahlon@ucdavis.edu

9167312578

Facility Contacts

Julie HT Dang, PhD

Role: primary

jtdang@ucdavis.edu

Other Identifiers

1K01CA258956-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2179292-1

Identifier Type: -

Identifier Source: org_study_id