Clinical trial NCT06247124: OPERATION WIPE OUT: Multi-Channel Communication Campaign to Promote HPV Vaccination in Chambers County, Alabama
Official title: OPERATION WIPE OUT: Multi-Channel Communication Campaign to Promote HPV Vaccination in Chambers County, Alabama
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV Vaccination
Keywords: HPV vaccination
Schools
High school students
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 29
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: high school students are enrolled as research participants to develop a multi-channel campaign to promote HPV vaccination
Primary purpose: PREVENTION

Brief 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.

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 outlines 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: HPV Vaccination at the county level
timeFrame: One year
Secondary outcomes:
measure: HPV vaccination at the school level
timeFrame: one year
Other outcomes:
measure: Knowledge and confidence among the high school students
timeFrame: 6 months
Locations:
city: Lafayette
country: United States
facility: Chambers County School District
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Isabel Scarinci, PhD
role: PRINCIPAL_INVESTIGATOR
References: