Increasing Vaccine Uptake Among Adolescents in the Rural South

NCT04999267 | Completed Results

• 1 other identifier: Pro00101137
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Vaccine Hesitancy

Keywords

Human papillomavirus (HPV); Adolescent; School based intervention; Vaccine; HPV vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 9 months

Secondary Outcomes (2)

• 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 Arms (1)

INVEST Intervention School Districts

EXPERIMENTAL

Other: INVEST

Interventions

INVEST OTHER

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.

INVEST Intervention School Districts

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• University of South Carolina: collaborator

Study Sites (2)

Duke University

Durham, North Carolina, 29340, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Chip Walter
• Organization: Duke University - Duke Human Vaccine Institute

chip.walter@duke.edu

919 620 5346

Study Officials

• Emmanuel Walter, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 10, 2021
• Study Start: August 31, 2021
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: December 10, 2025
• Results First Posted: December 4, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)