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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA235615-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.
The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation.
The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Practices randomly assigned to this arm will receive the multi-component intervention. |
|
| Wait list control group | No Intervention | Practices randomly assigned to this arm will be offered the intervention in the last two years of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Practice Facilitation | Other | Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of the HPV Vaccine 2-dose Series. | The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization | 24 months |
| Completion of the HPV Vaccine 2-dose Series. | The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine. | The proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization | 36 months |
| Sustainability of the Intervention Benefit for Completion of the HPV Vaccine. |
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Inclusion Criteria
Practices:
Providers:
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Allison King, M.D., Ph.D., MPH | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41746648 | Derived | Wang R, Liu L, Dodd S, Graham S, Rook S, Ericson L, Plax K, Barker A, McKay V, Silver MI, Newland JG, King AA. A Multicomponent Strategy to Increase Human Papillomavirus Vaccination Rates in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e260049. doi: 10.1001/jamanetworkopen.2026.0049. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Practices randomly assigned to this arm will receive the multi-component intervention. |
| FG001 | Wait List Control Group | Practices randomly assigned to this arm will be offered the intervention in the last two years of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group (24 Months Post-randomization) | Practices randomly assigned to this arm will receive the multi-component intervention. |
| BG001 | Wait List Control Group (24 Months Post-randomization) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Initiation of the HPV Vaccine 2-dose Series. | The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization | Posted | Count of Participants | Participants | 24 months |
|
The only potential adverse event is breach of confidentiality. Regular monitoring will occur while the participants are on follow-up (up to 36 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group (24 Months Post-randomization) | Practices randomly assigned to this arm will receive the multi-component intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison King, M.D., Ph.D., MPH | Washington University School of Medicine | 314-454-4291 | king_a@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2023 | Dec 15, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 16, 2022 | Oct 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Education | Other | An educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13. |
|
| Audit and Feedback | Other | Audit and feedback of vaccine coverage to increase motivation to engage in practice change. |
|
| Communication Strategy | Other | A communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation. |
|
The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization |
| 36 months |
| Washington University: Pediatric \& Adolescent Ambulatory Research Consortium | View source |
Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.
| BG002 | Intervention Group (36 Months Post-randomization) | Practices randomly assigned to this arm will receive the multi-component intervention. |
| BG003 | Wait List Control Group (36 Months Post-randomization) | Practices randomly assigned to this arm will be offered the intervention in the last two years of the study. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Primary | Completion of the HPV Vaccine 2-dose Series. | The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine. | The proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization | Posted | Count of Participants | Participants | 36 months |
|
|
|
| Secondary | Sustainability of the Intervention Benefit for Completion of the HPV Vaccine. | The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization | Posted | Count of Participants | Participants | 36 months |
|
|
|
| 0 |
| 2,151 |
| 0 |
| 2,151 |
| 0 |
| 2,151 |
| EG001 | Wait List Control Group (24 Months Post-randomization) | Practices randomly assigned to this arm will be offered the intervention in the last two years of the study. | 0 | 1,615 | 0 | 1,615 | 0 | 1,615 |
| EG002 | Intervention Group (36 Month Post-randomization) | Practices randomly assigned to this arm will receive the multi-component intervention. | 0 | 2,211 | 0 | 2,211 | 0 | 2,211 |
| EG003 | Wait List Control Group (36 Months Post-randomization) | Practices randomly assigned to this arm will be offered the intervention in the last two years of the study. | 0 | 1,410 | 0 | 1,410 | 0 | 1,410 |
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