Project Summary
PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Human papillomavirus, or HPV, is a sexually transmitted infection that can cause cancer or other health problems in men and women. An HPV vaccine for youth between the ages of 11 and 26 can protect them from HPV infection.
In this study, the research team is comparing three ways to increase the number of youth who get the HPV vaccine. One way is to send reminders to parents to have their child vaccinated. Another way is for clinics to provide specialized training for clinicians, such as doctors and nurses, and staff to make sure that the vaccine is offered to all eligible youth. The third way is to both send parent reminders and provide training for clinicians and health clinic staff.
Who can this research help?
Information from this study can help health clinics plan ways to increase use of the HPV vaccine among youth.
What is the research team doing?
The research team is working with seven Northeast Valley Health Corporation, or NEVHC, clinics in Los Angeles County to enroll 17,000 youth between the ages of 11 and 17 in the study. The clinics serve families with low incomes who have Medicaid or no insurance and speak mainly Spanish. The team is assigning the seven NEVHC clinics to one of three groups by chance.
In the first group, parents get a text message or mailed reminder to have their child vaccinated. In the second group, the research team trains clinicians and health clinic staff to make changes to clinic routines to ensure that the clinic always identifies youth who are eligible for the vaccine. The trainings also teach clinicians how to discuss the vaccine with parents and youth. In the third group, parents get a reminder to have their child vaccinated and researchers provide the same training for clinicians and staff.
The research team is looking at the health records of each child in the study to find out if the number of youth who have received the HPV vaccine increases over time. Researchers are also comparing how likely youth in each group are to be vaccinated.
Parents of youth who are patients at a NEVHC clinic; NEVHC clinicians, leaders, and staff; and people who work for community organizations that care about HPV vaccination are working with the research team to plan and conduct the study.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Cluster randomized controlled trial using a stepped wedge factorial design |
| Population | Youth ages 11–17 who have had at least 1 appointment in the last 2 years at 1 of the 7 NEVHC clinics participating in the study |
| Interventions/ Comparators |
|
| Outcomes | Primary: HPV vaccine series completed (based on electronic health record data) |
 |
1-year follow-up for study outcome |
Project Details