INVEST: Increase Vaccine Uptake in Adolescent in Rural South
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: INVEST Intervention
|
Other: 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.
|
| No Intervention: Control The control arm will not receive the INVEST Intervention and will receive the usual vaccine information materials by the schools. |
Outcome Measures
Primary Outcome Measures
- 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 [Baseline, 9 months]
HPV vaccination status (received at least one versus no doses) of middle schoolers (grades 6, 7, 8) will be obtained from official vaccination records before and after intervention implementation.
Secondary Outcome Measures
- 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 [Baseline, 9 months]
HPV vaccination status (received at least one versus no doses) of middle schoolers (grades 6, 7, 8) will be obtained from official vaccination records before and after intervention implementation.
- Difference in the post-intervention change in the proportion of adolescents who ever received at least one dose of HPV vaccination in the intervention group compared with the control group [Baseline, 9 months]
County-level data on HPV vaccination from control and intervention groups will be extracted from state registries.
- Difference in the post-intervention change in the proportion of adolescents who have completed the HPV vaccination series (two or three doses depending on age at vaccination initiation) in the intervention group compared with the control group [Baseline, 9 months]
County-level data on HPV vaccination from control and intervention groups will be extracted from state registries.
- Mean score representing 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Students in the 6th, 7th or 8th grade attending public middle schools in Cherokee County, South Carolina or Rockingham County, North Carolina school districts
-
Adolescents in control counties in North and South Carolina.
Exclusion Criteria:
- Individuals not able to consent for themselves
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rockingham County Public Schools | Rockingham | North Carolina | United States | 28379 |
| 2 | Cherokee County Public Schools | Gaffney | South Carolina | United States | 29340 |
Sponsors and Collaborators
- Duke University
- University of South Carolina
Investigators
- Principal Investigator: Emmanuel Walter, MD, MPH, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00101137