HPV IIS Reminder/Recall- New York State

NCT03057379 | Completed

• 1 other identifier: 16-002040
• Study Type: interventional
• Target: 30,616
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates among adolescents ages 11-17.

Conditions

Reminder Systems

Keywords

HPV vaccine; Immunization registry; Reminder recall

Outcome Measures

Primary Outcomes (2)

• Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)

  Did the adolescent initiate the HPV vaccine series? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via electronic medical record (EMR) direct transfer or manual entry.

  5 months from initial recall notices for the first dose

• Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)

  Did those eligible to complete the HPV vaccine series within the time frame of the study do so? The investigators are allowing up to 5 months after the first recall notice of the last dose (could be dose 2 or dose 3, depending on the age at which they received their first dose) for adolescents to complete their vaccination series. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.

  5 months from first reminder received for last dose

Secondary Outcomes (2)

• Differences between arms - initiation

  5 months

• Differences between arms - completion

  20 months

Study Arms (4)

Control arm

NO INTERVENTION

Usual source of care

1 R/R per Dose

EXPERIMENTAL

Sending up to one recall notice per dose of HPV vaccine needed

Other: Vaccine Reminder Recall

2 R/R per dose

EXPERIMENTAL

Sending up to two recall notice per dose of HPV vaccine needed

Other: Vaccine Reminder Recall

3 R/R per dose

EXPERIMENTAL

Sending up to three recall notice per dose of HPV vaccine needed

Other: Vaccine Reminder Recall

Interventions

Vaccine Reminder Recall OTHER

The investigators will be sending recall notices via phone call to 11-17 year olds who are eligible but lacking HPV vaccine doses recorded in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention)

1 R/R per Dose; 2 R/R per dose; 3 R/R per dose

Eligibility Criteria

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

You may qualify if:

• through 17 years of age
• patient of a participating practice (practices randomly selected)
• is either due for an HPV dose at baseline, or
• has initiated but not yet completed the HPV series at baseline

You may not qualify if:

• has completed the HPV vaccination series

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Cancer Institute (NCI): collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

University of California LA

Los Angeles, California, 99095, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Participants will be randomized to one of four arms to receive 0,1,2,or 3 reminders for overdue HPV vaccine doses.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: February 27, 2017
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

US (1)