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Clinical Trials/NCT04999267
NCT04999267
Completed
N/A

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

Duke University2 sites in 1 country2 target enrollmentAugust 31, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vaccine Hesitancy
Sponsor
Duke University
Enrollment
2
Locations
2
Primary Endpoint
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
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 31, 2021
End Date
November 3, 2022
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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)
  • Fidelity of Intervention Across Intervention Schools(9 months)

Study Sites (2)

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