Cervical Cancer Clinical Trial
Official title:
HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3
Verified date | May 2016 |
Source | Regenstrief Institute, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses of HPV vaccine for eligible male and female adolescents who have initiated vaccination.
Status | Completed |
Enrollment | 1305 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 11 Years to 17 Years |
Eligibility |
Inclusion Criteria: Provider Criteria - All pediatricians and nurse practitioners who provide health care at the 5 CHICA clinics will be included in this study Subject Criteria - Patients will be 11-17 year old - Males and females - A visit to at least one of the five CHICA clinics - Eligible for the 2nd or 3rd dose of HPV vaccine Exclusion Criteria: - Patients in the eligible age range who have not started or have completed the HPV vaccine series will be excluded |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Eskenazi Health Center Blackburn | Indianapolis | Indiana |
United States | Eskenazi Health Center Forest Manor | Indianapolis | Indiana |
United States | Eskenazi Health Center Pecar | Indianapolis | Indiana |
United States | Eskenazi Health Outpatient Care Center | Indianapolis | Indiana |
United States | Eskenazi Health West 38th Street | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Regenstrief Institute, Inc. | Indiana University, Merck Sharp & Dohme Corp. |
United States,
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* Note: There are 45 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients | To evaluate the rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients who have received 1 or 2 doses of vaccine. | Six Months | No |
Secondary | Assessment of Physician Acceptance of the Prompts | The study team will compare changes in vaccination rates with qualitative feedback from providers. | Six Months | No |
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