Increase Vaccine Uptake in Adolescent in Rural South

Study Overview
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Brief Summary
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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.

Official Title
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A Tailored School-based Intervention to INcrease VaccinE Uptake Among adoleScenTs (INVEST) in the Rural South

Conditions
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Vaccine Hesitancy

Intervention / Treatment
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* Other: INVEST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Any public middle school in Cherokee County, South Carolina or Rockingham County, North Carolina school districts
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INVEST Intervention<br> | Other: INVEST<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the proportion 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the proportion of adolescents who have completed the HPV vaccination series (2 or 3 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. | Baseline, 9 months | 
| Mean score representing 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human papillomavirus (HPV), Adolescent, School based intervention, Vaccine, HPV vaccine