CompletedNot Applicable

State Immunization Information Systems to Improve HPV Vaccination Rates

United States77,716 participantsStarted 2017-02-21

Plain-language 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).

Who can participate

Age range

11 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 5 months

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

Timeframe: 5 months

Trial details

NCT IDNCT02993965

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-15

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