HPV Centralized R/R RCT #2 - New York State

Summary

The work done in this trial builds off of the work previously conducted by this same research group in clinicaltrials.gov ID: NCT03057379. Due to some changes in study design, protocol, and cohort of interest, a new registration was warranted.

The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness, and sustainability of utilizing statewide immunization information systems (IISs) to conduct centralized reminder recall (R/R) to improve human papillomavirus (HPV) vaccination rates among adolescents 11-14 years of age.

The latest recommendations from the ACIP, as of February 2017, modified the vaccination schedule for the HPV series for eligible adolescents ages 11-14. Adolescents who receive dose #1 between the ages of 11 and 14 are now eligible for their second and final dose 6-12 months after their initial dose. Despite U.S. guidelines for vaccinating all adolescents starting at age 11 with the HPV vaccine, in 2012 only 53% of 13-17 year old females had \>1 dose and 35% had 3 doses; 21% of teen males had a vaccination. Modeling studies predict marked reduction in HPV associated cancers and in disparities in these cancers if high HPV vaccination rates can be achieved.

With this new dosing schedule for adolescents, the research team proposes to conduct a randomized control trial (RCT) utilizing the capabilities of the State Immunization Information System (IIS), and create a HPV-specific R/R autodialer and text message to be delivered to the parents of patients ages 11-14 of randomly selected practices within New York State (excluding NYC). Upon conclusion of this trial, researchers will develop a toolkit for dissemination so that other state IIS systems may replicate these centralized reminder recall procedures.

Conditions

• Vaccines

Interventions

BEHAVIORAL

HPV Vaccine Reminder Recall - Autodialer

Investigators will send out HPV vaccine reminder recall notices via autodialer message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders)

BEHAVIORAL

HPV Vaccine Reminder Recall - Texting

Investigators will send out HPV vaccine reminder recall notices via text message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Colorado, Denver

  collaborator OTHER

• New York State Department of Health

  collaborator OTHER_GOV

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Peter Szilagyi, MD MPH · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-27

Primary Completion

2019-11-05

Completion

2019-11-05

Countries

• United States

Study Locations