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Increase Vaccine Uptake in Adolescent in Rural South (INVEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04999267
Recruitment Status : Recruiting
First Posted : August 10, 2021
Last Update Posted : February 11, 2022
Sponsor:
Collaborator:
University of South Carolina
Information provided by (Responsible Party):
Duke University

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
Vaccine Hesitancy Other: INVEST Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2080 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Tailored School-based Intervention to INcrease VaccinE Uptake Among adoleScenTs (INVEST) in the Rural South
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

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.



Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. 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 [ Time Frame: 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.

  2. 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 [ Time Frame: Baseline, 9 months ]
    County-level data on HPV vaccination from control and intervention groups will be extracted from state registries.

  3. 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 [ Time Frame: Baseline, 9 months ]
    County-level data on HPV vaccination from control and intervention groups will be extracted from state registries.

  4. Mean score representing fidelity of intervention across intervention schools. [ Time Frame: 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



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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04999267


Contacts
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Contact: Chip Walter, MD, MPH 919 970 5720 chip.walter@duke.edu
Contact: Grace Davis, MS 919-385-5786 grace.davis@duke.edu

Locations
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United States, North Carolina
Rockingham County Public Schools Recruiting
Rockingham, North Carolina, United States, 28379
Contact: Amanda Perkins       aperkins@rock.k12.nc.us   
United States, South Carolina
Cherokee County Public Schools Recruiting
Gaffney, South Carolina, United States, 29340
Contact: Mary Beattie       Mary.Beattie@cherokee1.org   
Sponsors and Collaborators
Duke University
University of South Carolina
Investigators
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Principal Investigator: Emmanuel Walter, MD, MPH Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04999267    
Other Study ID Numbers: Pro00101137
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Human papillomavirus (HPV)
Adolescent
School based intervention
Vaccine
HPV vaccine