Clinical trial NCT02993965: State Immunization Information Systems to Improve HPV Vaccination Rates
Official title: State Immunization Information Systems to Improve HPV Vaccination Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine
Human Papiloma Virus Vaccine
HPV Vaccine
Immunization
Health Registry
Adolescent Health
Reproductive Health
Preventive Health Services
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Cancer Institute (NCI)
First posted: 2016-12-15
Enrollment: 77716
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed description: 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 HPV vaccination rates among adolescents ages 11-17, and additionally look at the 11-14 year old subset for whom a new 2 dose series has recently been recommended. The investigators will extend previous research on effectiveness of centralized R/R to a new population--adolescents due for HPV vaccine-- and test the use of centralized R/R as a cancer-prevention strategy. Investigators will assess the effect of centralized R/R in two states--one with and one without mandated reporting of vaccinations to IISs, and disseminate IIS R/R to other states. Investigators will implement, evaluate (using the RE-AIM framework 31-36), and disseminate a collaborative, IIS-based centralized HPV vaccine R/R model in which partnerships of public health systems and primary care practices in two states (NY, CO) collaborate to remind parents about HPV vaccination.

Specific Aims and hypotheses:

Aim #1: Adapt IIS messages and delivery systems (e.g., algorithms) previously developed for centralized R/R for other vaccines to fit HPV vaccine IIS R/R.

Aim #2: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing vaccine rates \[initial dose (HPV#1) and a complete series (HPV#2 or #3)\] among teens.

Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing initiation and completion rates for the HPV vaccine series in adolescents ages 11-17 years. The investigators will use a within-practice design, randomizing patients within randomly selected primary care practices to IIS-C R/R (1, 2, or 3 reminders per dose) compared to usual care (0 reminders from this study). The investigators will apply the RE-AIM framework to evaluate the reach, effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.

Hypothesis 2a: IIS-C R/R will result in higher HPV vaccination rates than usual care.

Hypothesis 2b: IIS-C R/R will result in higher HPV vaccination rates than usual care in key subgroups (males and females, younger and older teens, urban//rural teens).

Hypothesis 2c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care.

Aim #3: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) R/R using autodialer (phone) or mail in increasing vaccine rates \[initial dose (HPV#1) and a complete series (HPV#2)\] and decreasing time to completion among teens 11-14.

Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized IIS-based (IIS-C) R/R using either autodialer (phone) or postcard (mail) in increasing initiation and completion rates for the newly implemented HPV vaccine 2 dose series in adolescents ages 11-14 years. We will use a within-practice design, randomizing patients within randomly selected primary care practices to IIS-C R/R using either an autodailer or postcards (up to 2 reminders per dose needed) compared to usual care (0 reminders from this study). We will apply the RE-AIM framework to evaluate the reach, effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.

Hypothesis 3a: IIS-C R/R (either modality) will result in higher HPV vaccination rates than usual care.

Hypothesis 3b: IIS-C R/R (either modality) will result in higher HPV vaccination rates than usual care in key subgroups (males and females, younger and older teens, urban//rural teens).

Hypothesis 3c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care. IIS-C R/R using autodialer will be more cost effective than IIS-C R/R using postcards.

Aim #4: Disseminate IIS-C R/R across NY and CO and pilot in four IISs: (a) Develop an IIS-C HPV R/R toolkit, (b) Use a technical advisory group, (c) Initiate IIS-C R/R in four other IISs \[Yr. 4\].

By the end of the study investigators will have a feasible, sustainable, cost-effective model for HPV vaccine reminders that can be used nationally to prevent cervical cancer and other HPV-related cancers.

Eligibility criteria: Inclusion Criteria:

* 11 through 17 years of age (trial 1)
* 11 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)
timeFrame: 5 months
measure: Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)
timeFrame: 5 months
Secondary outcomes:
measure: Differences between arms - initiation
timeFrame: 5 months
measure: Differences between arms - completion
timeFrame: 20 months
measure: Differences between modalities - initiation
timeFrame: 5 months
measure: Differences between modalities - completion
timeFrame: 5 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Allison Kempe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.