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| Name | Class |
|---|---|
| University of South Carolina | OTHER |
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The benefits of adolescent vaccines are well known for preventing meningococcal infection and human papillomavirus (HPV)-related pre-cancerous lesions. Yet, many adolescents in the United States (US) remain under-vaccinated, with vaccination rates among rural adolescents significantly lower than among their urban peers. In addition, there are urban-rural disparities in the coverage of HPV vaccine, particularly in Southern states like North and South Carolina, which currently fall below the Healthy People 2020 goal of ≥80% coverage. The goal of the proposed study is to evaluate the feasibility and preliminary efficacy of a school-based intervention for increasing vaccine uptake among adolescents in rural North and South Carolina.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVEST Intervention School Districts | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVEST | Other | The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Percentage of Adolescents Who Ever Received at Least One Dose of HPV Vaccination in the Intervention Group After the Intervention Implementation Compared With Before Intervention Implementation | HPV vaccination status (received at least one versus no doses) of middle schoolers (by district) will be obtained from official vaccination records before and after intervention implementation. | Baseline, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Percentage of Adolescents Who Have Completed the HPV Vaccination Series (2 Doses Depending on Age at Vaccination Initiation) in the Intervention Group After Implementation Compared With Before Intervention Implementation | HPV vaccination status (received at least one versus no doses) of middle schoolers (by district) will be obtained from official vaccination records before and after intervention implementation. |
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Inclusion Criteria:
- Any public middle school in Cherokee County, South Carolina or Rockingham County, North Carolina school districts
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Walter, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 29340 | United States | ||
| University of South Carolina |
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School nurses from intervention schools were not considered enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | INVEST Intervention School Districts | INVEST: The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The participants are school districts; baseline characteristics data were not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | INVEST Intervention | INVEST: The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| 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 | Difference in the Percentage of Adolescents Who Ever Received at Least One Dose of HPV Vaccination in the Intervention Group After the Intervention Implementation Compared With Before Intervention Implementation | HPV vaccination status (received at least one versus no doses) of middle schoolers (by district) will be obtained from official vaccination records before and after intervention implementation. | Posted | Number | percentage of adolescents | Baseline, 9 months | School District | School District |
|
Participants are school districts, therefore no adverse events were collected.
Participants are school districts, therefore no adverse events were collected.
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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 | INVEST Intervention | INVEST: The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chip Walter | Duke University - Duke Human Vaccine Institute | 919 620 5346 | chip.walter@duke.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 | Oct 29, 2025 | Oct 29, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2021 | Sep 1, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
| Baseline, 9 months |
| Fidelity of Intervention Across Intervention Schools | Score items (0-100%) from a study specific checklist (Fidelity Checklist) will be completed by school nurses from intervention schools with a high score (100%) indicating more adherence to the study intervention and 0% indicating the worse score and less adherence to the study intervention | 9 months |
| Columbia |
| South Carolina |
| 29208 |
| United States |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
|
|
|
| Secondary | Difference in Percentage of Adolescents Who Have Completed the HPV Vaccination Series (2 Doses Depending on Age at Vaccination Initiation) in the Intervention Group After Implementation Compared With Before Intervention Implementation | HPV vaccination status (received at least one versus no doses) of middle schoolers (by district) will be obtained from official vaccination records before and after intervention implementation. | Posted | Number | percentage of adolescents | Baseline, 9 months | School District | School District |
|
|
|
|
| Secondary | Fidelity of Intervention Across Intervention Schools | Score items (0-100%) from a study specific checklist (Fidelity Checklist) will be completed by school nurses from intervention schools with a high score (100%) indicating more adherence to the study intervention and 0% indicating the worse score and less adherence to the study intervention | School nurses from intervention schools. | Posted | Mean | Full Range | Percent | 9 months | School District | School District |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D001519 | Behavior |