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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01CA250989-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Wisconsin, Madison | OTHER |
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This trial will compare two ways to improve communication about HPV vaccination in primary care. The research team will work with primary care clinics. Some clinics will receive communication training from an outside expert. Other clinics will receive the same training from a vaccine champion from their healthcare system.
The researchers will conduct a cluster randomized non-inferiority trial. The trial will compare two ways of delivering a communication workshop called Announcement Approach Training (AAT). AAT is designed to improve communication about HPV vaccination in primary care. The researchers will randomize clinics within participating healthcare systems. Some clinics will receive the training from an outside expert. Other clinics will receive the same training from a vaccine champion from their own system. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 12 months. The study will engage clinical staff. Researchers will not have direct contact with children or their families.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Champion AAT | Experimental | Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination. The training will be organized and delivered by vaccine champions from participating healthcare systems. |
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| Traditional AAT | Experimental | Staff in clinics randomized to this arm will also receive Announcement Approach Training (AAT). The training will be organized and delivered by outside experts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Champion Announcement Approach Training | Behavioral | AAT is a one-hour communication workshop that trains clinical staff how to recommend HPV vaccine for children ages 9-12. In the champion arm, vaccine champions will deliver the training using slides and a standardized script. They will also conduct outreach and sustainability planning. |
| Measure | Description | Time Frame |
|---|---|---|
| HPV vaccination (≥1 dose), 9-12 year olds | Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline | from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HPV vaccination (2 doses), 9-12 year olds | Proportion of unvaccinated children who complete the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline | from baseline to 12 months |
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This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children to evaluate intervention effectiveness. We will not enroll children or interact with them directly.
Inclusion Criteria
Clinics are eligible if they:
Children's medical records will be eligible to be included in the dataset if children:
Exclusion criteria
Clinics are excluded if they:
Children's medical records will be excluded if children:
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| Name | Affiliation | Role |
|---|---|---|
| Noel T Brewer, PhD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States | ||
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2023 | May 18, 2023 | SAP_000.pdf |
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cluster randomized design in which clinics will be randomized within healthcare systems
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| Traditional Announcement Approach Training | Behavioral | AAT is a one-hour communication workshop that trains clinical staff how to recommend HPV vaccine for children ages 9-12. In the traditional arm, outside experts will deliver the training using the same slides and script. |
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| University of Wisconsin - Madison |
| Madison |
| Wisconsin |
| 53726 |
| United States |