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

NCT03294551 | Completed

• 2 other identifiers: 17-0015595R01CA187707-02
• Study Type: interventional
• Target: 37,003
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HPV Vaccine; immunization registry; Reminder recall (R/R)

Outcome Measures

Primary Outcomes (2)

• Initiation of the HPV 2-dose series

  Receipt and documentation of the initial dose of the vaccine within the series as recorded in the NYSIIS database. Investigators are allowing 5 months after the initial reminder recall was sent as the timeline of attributing vaccination status to the intervention

  5 months from the first reminder received for the first dose of HPV vaccine

• Completion of the HPV 2-dose series

  Receipt and documentation of the final dose of the vaccine series as recorded within the NYSIIS database. Investigators are allowing up to 5 months after the first reminder recall for the second dose was received. If vaccination is received after that 5 month period, investigators will not attribute change in vaccination status to the reminder.

  5 months from the first reminder received for the last dose of HPV vaccine

Secondary Outcomes (1)

• Cost of the R/R intervention - autodialers and texting

  17 months - entirety of the trial

Study Arms (3)

Standard of Care Control

NO INTERVENTION

Usual source of care

HPV Vaccine Reminder Recall - Autodialer

EXPERIMENTAL

HPV Vaccine Reminder Recall - Autodialer: Receive up to 4 reminders via telephone (live call or voicemail) - includes brief educational message + providers name + providers telephone number

Behavioral: HPV Vaccine Reminder Recall - Autodialer

HPV Vaccine Reminder Recall - Texting

EXPERIMENTAL

HPV Vaccine Reminder Recall - Texting: Receive up to 4 reminders via text message - includes brief educational message + providers name + providers telephone number

Behavioral: HPV Vaccine Reminder Recall - Texting

Interventions

HPV Vaccine Reminder Recall - Autodialer BEHAVIORAL

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)

HPV Vaccine Reminder Recall - Autodialer

HPV Vaccine Reminder Recall - Texting BEHAVIORAL

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)

HPV Vaccine Reminder Recall - Texting

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Cancer Institute (NCI): collaborator
• University of Colorado, Denver: collaborator
• New York State Department of Health: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Gurfinkel D, Kempe A, Albertin C, Breck A, Zhou X, Vangala S, Beaty B, Rice J, Tseng CH, Campbell JD, Valderrama R, Rand C, Humiston SG, Roth H, Arora S, Szilagyi P. Centralized Reminder/Recall for Human Papillomavirus Vaccination: Findings From Two States-A Randomized Clinical Trial. J Adolesc Health. 2021 Oct;69(4):579-587. doi: 10.1016/j.jadohealth.2021.02.023. Epub 2021 Apr 10.

  PMID: 33846054 DERIVED

Study Officials

• Peter Szilagyi, MD MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair Clinical Research, Pediatrics

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: October 27, 2017
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)