OPERATION WIPE OUT: Multi-Channel Communication Campaign to Promote HPV Vaccination in Chambers County, Alabama

The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination for all children and adults ages 9 to 26 in the U.S. However, HPV vaccination rates nationally and in Alabama lag far behind the Healthy People 2020 goal of 80% coverage. Despite multiple efforts, Alabama still ranks third in cervical cancer mortality and incidence nationally with great disparities within the state, particularly between urban and rural counties. In order to address this public health challenge, organizations have come together to develop, implement, and evaluate a statewide action plan to eliminate cervical cancer as a public health problem in Alabama by 2033. This plan was officially launched by the State Health Officer in May 2023 as a partnership between government, academia, civic organizations, and non-profit organizations and is known as OPERATION WIPE OUT. The overall goal of this Supplement is to develop, implement, and examine the feasibility and scalability of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake that is designed and delivered by high school students with the support of OPERATION WIPE OUT partners and linked to school-based vaccination in a rural county that has the highest cervical cancer incidence in the state (Chambers County). The specific aims are: (1) To develop and examine the feasibility of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake with high school students being agents of change and provision of school-based vaccination; and (2) To examine specific features of the multi-channel communication campaign regarding scalability, sustainability, and potentially a future full-scale implementation science trial. The primary outcome will be HPV vaccination uptake at the county level obtained Alabama Department of Public Health Vaccination Registry (ImmPRINT). Additionally, treatment fidelity and scalability assessments will be conducted to inform sustainability efforts.

Study Overview

• Status: Recruiting
• Conditions: HPV Vaccination
• Intervention / Treatment: Behavioral: multi-channel communication campaign to promote HPV vaccination

Detailed Description

The human papillomavirus (HPV) is the most common sexually transmitted infection in the U.S., and it has been well established that high-risk HPV infection is causally related to cervical, vaginal, vulvar, anal, and oropharyngeal cancer. This discovery led to the development of a safe and effective preventive vaccine that is available in U.S. through most health insurances or federally-funded programs. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination for all children and adults ages 9 to 26 in the U.S. However, HPV vaccination rates nationally and in Alabama lag far behind the Healthy People 2020 goal of 80% coverage. Despite multiple efforts, Alabama still ranks third in cervical cancer mortality and incidence nationally with great disparities within the state, particularly between urban and rural counties. In order to address this public health challenge, organizations have come together to develop, implement, and evaluate a statewide action plan to eliminate cervical cancer as a public health problem in Alabama by 2033. This plan was officially launched by the State Health Officer in May 2023 as a partnership between government, academia, civic organizations, and non-profit organizations and is known as OPERATION WIPE OUT. While the plan is comprehensive and we have outlined specific evidence-based strategies to promote HPV vaccination along with cervical cancer screening/follow-up, the evidence on multi-channel communication interventions (besides provider-focused interventions) to promote HPV vaccination uptake at the population level is scarce, and the results are mixed. The overall goal of this Supplement is to develop, implement, and examine the feasibility and scalability of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake that is designed and delivered by high school students with the support of OPERATION WIPE OUT partners and linked to school-based vaccination in a rural county that has the highest cervical cancer incidence in the state (Chambers County). Key components will include: (a) capacity building of high school students providing them with knowledge, skills, and support to develop and implement the campaign; (b) engagement of parents, teachers, school nurses, and school administrators); and (c) school-based vaccination. The specific aims are: (1) To develop and examine the feasibility of a theory-driven, participatory multi-channel communication campaign to promote HPV vaccination uptake with high school students being agents of change and provision of school-based vaccination; and (2) To examine specific features of the multi-channel communication campaign regarding scalability, sustainability, and potentially a future full-scale implementation science trial. The primary outcome will be HPV vaccination uptake at the county level. Alabama has a robust vaccination registry managed by Alabama Department of Public Health (ImmPRINT). Additionally, treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) will be conducted to inform sustainability efforts.

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabel C Scarinci, PhD; Phone Number: 2059757177; Email: scarinci@uab.edu

Study Locations

• United States
  • Alabama
    • Lafayette, Alabama, United States, 36862
      • Recruiting
      • Chambers County School District
      • Contact: Jennifer Williams, RN; Phone Number: 334-864-9343; Email: williamsje@chambersk12.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• High school students enrolled in the Health Science Program at the Chambers County School District, Alabama

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HPV vaccination; Multi-channel campaign to promote HPV vaccination	Behavioral: multi-channel communication campaign to promote HPV vaccination; High school students will develop, implement, and evaluate a multi-channel communication campaign to promote HPV vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Vaccination at the county level	HPV vaccination uptake at the county level	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV vaccination at the school level	HPV vaccination at the school level	one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge and confidence among the high school students	Pre- and post-training level of knowledge and confidence among the high school students participating in the intervention	6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Isabel Scarinci, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Schools; HPV vaccination; High school students
• Other Study ID Numbers: IRB3000011735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We only have 12 students enrolled in the research and we need to keep confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No