Vaccine Hesitancy
Conditions
Keywords
Human papillomavirus (HPV), Adolescent, School based intervention, Vaccine, HPV vaccine
Brief summary
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.
Interventions
OTHERINVEST
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.
Sponsors
University of South Carolina
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
\- Any public middle school in Cherokee County, South Carolina or Rockingham County, North Carolina school districts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, 9 months | 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. |
| Fidelity of Intervention Across Intervention Schools | 9 months | 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 |
Countries
United States
Participant flow
Pre-assignment details
School nurses from intervention schools were not considered enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Baseline, 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVEST Intervention | 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 | 21.7 percentage of adolescents |
p-value: <0.0001Chi-squared
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.
Time frame: Baseline, 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVEST Intervention | 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 | 7.6 percentage of adolescents |
p-value: <0.0001Chi-squared
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
Time frame: 9 months
Population: School nurses from intervention schools.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| INVEST Intervention | Fidelity of Intervention Across Intervention Schools | 87.5 Percent |