State Immunization Information Systems to Improve HPV Vaccination Rates

NCT02993965 | Completed

• 2 other identifiers: 15-15601R01CA187707-01A1
• Study Type: interventional
• Target: 77,716
• 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 (with a more focused look at the new two dose series for 11-14 year olds).

Conditions

Vaccine; Human Papiloma Virus Vaccine; HPV Vaccine; Immunization; Health Registry; Adolescent Health; Reproductive Health; Preventive Health Services

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 EMR direct transfer or manual entry.

  5 months

• 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 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 EMR direct transfer or manual entry.

  5 months

Secondary Outcomes (4)

• Differences between arms - initiation

  5 months

• Differences between arms - completion

  20 months

• Differences between modalities - initiation

  5 months

• Differences between modalities - completion

  5 months

Study Arms (7)

Control 11-17

NO INTERVENTION

No additional intervention done aside from usual care for 11-17 year olds

1 R/R per Dose 11-17

EXPERIMENTAL

Sending up to one recall notice per dose of HPV vaccine needed for 11-17 year olds

Other: Vaccine Reminder/Recall

2 R/R per Dose 11-17

EXPERIMENTAL

Sending up to two recall notices per dose of HPV vaccine needed for 11-17 year olds

Other: Vaccine Reminder/Recall

3 R/R per Dose 11-17

EXPERIMENTAL

Sending up to three recall notices per dose of HPV vaccine needed for 11-17 year olds

Other: Vaccine Reminder/Recall

Control 11-14

NO INTERVENTION

No additional intervention done aside from usual care for 11-14 year olds

Phone R/R 11-14

EXPERIMENTAL

Sending up to two recall notices per dose of HPV vaccine needed via autodialer for 11-14 year olds

Other: Vaccine Reminder/Recall

Mail R/R 11-14

EXPERIMENTAL

Sending up to two recall notices per dose of HPV vaccine needed via mailed postcards for 11-14 year olds

Other: Vaccine Reminder/Recall

Interventions

Vaccine Reminder/Recall OTHER

The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination.

1 R/R per Dose 11-17; 2 R/R per Dose 11-17; 3 R/R per Dose 11-17; Mail R/R 11-14; Phone R/R 11-14

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• through 17 years of age (trial 1)
• through 14 years of age (trial 2)
• defaulted to our selected clinics within CIIS
• is either due for an HPV dose at baseline according to Advisory Committee on Immunization Practices (ACIP) guidelines, or
• has initiated but not yet completed the HPV series at baseline

You may not qualify if:

• Has completed the HPV vaccine series according to Advisory Committee on Immunization Practices (ACIP) guidelines
• Any child whose parents have requested removal from the immunization registry

Sponsors & Collaborators

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

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, 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

• Allison Kempe, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 15, 2016
• Study Start: February 21, 2017
• Primary Completion: March 15, 2019
• Study Completion: July 31, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)