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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01164 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This clinical trial studies an educational intervention for parents and providers in increasing human papillomavirus (HPV) vaccination rates in younger girls in Ohio Appalachia. Educational interventions may be effective in increasing the number of participants whose daughters receive HPV vaccination.
PRIMARY OBJECTIVES:
I. Implement a multi-level HPV vaccine educational intervention directed at 3 levels within participating 12 Ohio Appalachia counties that includes information about cervical cancer, cervical cancer screening, HPV, the HPV vaccine, communication skills training to improve parent-health care provider conversations about the HPV vaccine, and organizational level components.
II. Evaluate the effectiveness of the multi-level HPV vaccine educational intervention in a group randomized controlled trial in 12 Ohio Appalachia counties.
OUTLINE: Participants are randomized to 1 of 2 arms.
Arm I: Parents and health care providers receive educational materials about HPV vaccination by mail or in-person review with project staff including a culturally tailored HPV and cervical cancer educational video and brochures, a question and answer (Q & A) fact sheet, and a HPV and cervical cancer resource list. Clinics receive waiting and exam room posters and brochures, tabletop cards, reminder cards to mail to participants, an information resource list, newsletter, vaccine tracking system, and "invitation to be vaccinated" letter to mail to parents.
Arm II: Parents and health care providers receive educational materials about influenza vaccination by mail or in-person review with project staff.
After completion of study, participants are followed up at 3 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I-HPV vaccine education | Experimental | The educational intervention is that parents and providers receive materials about HPV by mail including HPV/ cervical cancer videos and brochures, fact sheets, HPV/cervical cancer resource lists. Clinics receive posters, brochures, tabletop/reminder cards, resource lists, newsletters, and "invitation to be vaccinated" letters for parents. |
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| Arm II- Flu vaccine education | Active Comparator | The educational intervention is that parents and providers receive materials about Flu by mail including Flu brochures, fact sheets, Flu resource lists. Clinics receive posters and brochures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Receive HPV vaccination educational materials |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of daughters of participating parents who received their first HPV vaccination | A logistic random effects model will be used. A t-test of the coefficient for intervention status will be used to determine if there is a difference in the expected proportion of vaccinated patients across treatment arms. | Within 3 months of viewing educational material |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of daughters of participants in the intervention arm who received a second and third dose of the HPV vaccine | Separate logistic random effects models will be fit for each vaccination and t-tests of the fixed intervention effect will be used to compare treatment arms. | Up to 6 months |
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Inclusion Criteria:
LEVEL 2: Health care providers
Exclusion Criteria:
LEVEL 1: Parents
LEVEL 2: Health care providers
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| Name | Affiliation | Role |
|---|---|---|
| Electra Paskett | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| educational intervention | Other | Receive influenza vaccination educational materials |
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| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |