Trial Outcomes & Findings for Increasing Vaccine Uptake Among Adolescents in the Rural South (NCT NCT04999267)
NCT ID: NCT04999267
Last Updated: 2025-12-10
Results Overview
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.
COMPLETED
NA
2 participants
Baseline, 9 months
2025-12-10
Participant Flow
School nurses from intervention schools were not considered enrolled.
Unit of analysis: School District
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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2868 2
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Overall Study
COMPLETED
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2868 2
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Vaccine Uptake Among Adolescents in the Rural South
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline, 9 monthsHPV 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.
Outcome measures
| Measure |
INVEST Intervention
n=2 School District
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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|---|---|
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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
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21.7 percentage of adolescents
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SECONDARY outcome
Timeframe: Baseline, 9 monthsHPV 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.
Outcome measures
| Measure |
INVEST Intervention
n=2 School District
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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|---|---|
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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
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7.6 percentage of adolescents
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SECONDARY outcome
Timeframe: 9 monthsPopulation: School nurses from 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
Outcome measures
| Measure |
INVEST Intervention
n=2 School District
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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|---|---|
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Fidelity of Intervention Across Intervention Schools
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87.5 Percent
Interval 76.1 to 98.9
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Adverse Events
INVEST Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chip Walter
Duke University - Duke Human Vaccine Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place