Purpose

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.

Condition

Eligibility

Eligible Ages
Between 10 Years and 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of California Davis Health
Sacramento, California 95817
Contact:
Julie HT Dang, PhD
jtdang@ucdavis.edu

More Details

NCT ID
NCT06831929
Status
Recruiting
Sponsor
University of California, Davis

Study Contact

Ramneek Kahlon, BS
9167312578
rkahlon@ucdavis.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.