Increase Vaccine Uptake in Adolescent in Rural South

Vaccine Hesitancy Clinical Trial

— INVEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04999267
• Other study ID #: Pro00101137
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: November 3, 2022

Study information

• Verified date: November 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1236
• Est. completion date: November 3, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any public middle school in Cherokee County, South Carolina or Rockingham County, North Carolina school districts

Related Conditions & MeSH terms

• Vaccine Hesitancy

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.

Locations

Country	Name	City	State
United States	Cherokee County Public Schools	Gaffney	South Carolina
United States	Rockingham County Public Schools	Rockingham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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