Clinical trial NCT03057379: HPV IIS Reminder/Recall- New York State
Official title: State Immunization Information Systems to Improve HPV Vaccination Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reminder Systems
Keywords: HPV vaccine
Immunization registry
Reminder recall
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Colorado, Denver
First posted: 2017-02-20
Enrollment: 30616
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of four arms to receive 0,1,2,or 3 reminders for overdue HPV vaccine doses.
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.

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. 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 \[initial dose (HPV#1) and a complete series (HPV#3)\] 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: 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
* 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

Exclusion Criteria:

* has completed the HPV vaccination series

Primary outcomes:
measure: Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)
timeFrame: 5 months from initial recall notices for the first dose
measure: Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)
timeFrame: 5 months from first reminder received for last dose
Secondary outcomes:
measure: Differences between arms - initiation
timeFrame: 5 months
measure: Differences between arms - completion
timeFrame: 20 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California LA
state: California
Study officials:
References: