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

Completed · Not applicable

Conditions studied: Vaccines

In brief

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.

Key facts

Study ID

NCT03294551

Run by

University of California, Los Angeles

People needed

37003

Starts

2017-10-27

Expected to finish

2019-11-05

Last updated by the study team

2021-05-27

Who can join

Age: 11 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 11 to 14 years of age
• patient of a participating practice in New York State (practices were randomly selected)
• is due for an HPV dose at baseline, or
• has initiated but not yet completed the HPV series at baseline
• immunization record within the New York State Immunization Information System (NYSIIS) database

You may not qualify if…

• is not a patient of a participating practice that was randomly selected in New York State
• has completed the HPV vaccination series
• does not have a valid record within the NYSIIS database

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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