Reminder SystemsNCT03057379
HPV IIS Reminder/Recall- New York State
A study testing Vaccine Reminder Recall in people with Reminder Systems, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Reminder Systems
- What is being tested?
- Vaccine Reminder Recall
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,616 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 17 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- has completed the HPV vaccination series
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California LA
Los Angeles, California, 99095
About this study
Official title: State Immunization Information Systems to Improve HPV Vaccination Rates
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.
Read the 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.
- Conditions
- Reminder Systems
- Being tested
- Vaccine Reminder Recall
- Keywords
- HPV vaccine, Immunization registry, Reminder recall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine Reminder RecallOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Vaccine Reminder Recall |
| 2 R/R per dose | Experimental | Sending up to two recall notice per dose of HPV vaccine needed Receives: Other: Vaccine Reminder Recall |
| 3 R/R per dose | Experimental | Sending up to three recall notice per dose of HPV vaccine needed Receives: Other: Vaccine Reminder Recall |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 months from first reminder received for last dose
Secondary outcomes (2)
Differences between arms - initiation
Is 1, 2, or 3 reminders per arm most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. We will compare the arms (receipt of zero, 1, 2 or 3 reminders) to see if there are any differences between the arms in terms of receipt of the 1st dose of HPV vaccine
Measured: 5 months
Differences between arms - completion
Is 1, 2, or 3 reminders per arm most effective and cost effective for completion. Because the second or third dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 20 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start27 Feb 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reminder SystemsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of four arms to receive 0,1,2,or 3 reminders for overdue HPV vaccine doses.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30,616 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter G Szilagyi, MD MPH, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057379
- Sponsor's protocol ID
- 16-002040
- Status last verified
- Apr 2020
- First submitted
- 15 Feb 2017
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State Immunization Information Systems to Improve HPV Vaccination Rates
- ClinicalTrials.gov ID
- NCT03057379
- Acronym / sponsor ID
- 16-002040
- Conditions
- Reminder Systems
- Keywords
- HPV vaccine, Immunization registry, Reminder recall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,616 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Colorado, Denver
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomized to one of four arms to receive 0,1,2,or 3 reminders for overdue HPV vaccine doses.
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Usual source of care |
| 1 R/R per Dose | Experimental | Other: Vaccine Reminder RecallSending up to one recall notice per dose of HPV vaccine needed |
| 2 R/R per dose | Experimental | Other: Vaccine Reminder RecallSending up to two recall notice per dose of HPV vaccine needed |
| 3 R/R per dose | Experimental | Other: Vaccine Reminder RecallSending up to three recall notice per dose of HPV vaccine needed |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- has completed the HPV vaccination series
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine Reminder RecallThe 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) | Other | 1 R/R per Dose, 2 R/R per dose, 3 R/R per dose |
Primary outcome
Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)
Time frame: 5 months from initial recall notices for the first dose
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.
Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)
Time frame: 5 months from first reminder received for last dose
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.
2 secondary outcomes
Differences between arms - initiation
Time frame: 5 months
Differences between arms - completion
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccine Reminder Recall in people with Reminder Systems, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry) (time frame: 5 months from initial recall notices for the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.