Vaccine Clinical Trial
Official title:
State Immunization Information Systems to Improve HPV Vaccination Rates
Verified date | August 2020 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 77716 |
Est. completion date | July 31, 2020 |
Est. primary completion date | March 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Cancer Institute (NCI), University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested in the 11-17 year old group. | 5 months | |
Secondary | 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. This will be tested in the 11-17 year old group. For 11-14 year olds, completion is 2 doses. For 15-17 year olds, completion is 3 doses. | 20 months | |
Secondary | Differences between modalities - initiation | Are mail or phone reminders most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested with the 11-14 year old group only. | 5 months | |
Secondary | Differences between modalities - completion | Are mail or phone reminders most effective and cost effective for completion. This will be tested only in the 11-14 year old group, so completion will equal 2nd dose. Because the second dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 17 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. | 5 months |
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