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

HPV Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247124
• Other study ID #: IRB3000011735
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Isabel C Scarinci, PhD
• Phone: 2059757177
• Email: scarinci[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• HPV Vaccination

Intervention

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.

Locations

Country	Name	City	State
United States	Chambers County School District	Lafayette	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	HPV Vaccination at the county level	HPV vaccination uptake at the county level	One year
Secondary	HPV vaccination at the school level	HPV vaccination at the school level	one year