HPV Ends Here: Increasing Uptake of the HPV Vaccine

University of California (UC) Davis

Status: Enrolling

Conditions: HPV Vaccine

Treatments: Behavioral: Intervention Arm

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06831929

1K01CA258956-01A1 (U.S. NIH Grant/Contract)

2179292-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,232 estimated patients

Sex: All

Ages: 10 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,232 participants in 2 patient groups

Control Arm

No Intervention group

Description:

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

Intervention Arm

Experimental group

Description:

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

Treatment:

Behavioral: Intervention Arm