Feasibility Trial of a Multi-level Media Production and Social Marketing Campaign to Reduce HPV Vaccine Hesitancy

Appalachian Voices for Health - Feasibility Trial of a Multi-level Media Production and Social Marketing Campaign to Reduce HPV Vaccine Hesitancy

Since 2019, the HPV working group of the University of Virginia Cancer Center's Southwest Virginia Community Advisory Board has developed and executed strategies to increase regional HPV vaccination rates. Members collaboratively developed Appalachian Voices for Health, a multi-level media production and social marketing intervention. This novel intervention builds on the past efforts of the working group and the engaged organizations; takes into account the impact of vaccine hesitancy on HPV vaccination uptake; and incorporates best practices. Through the intervention, Nursing and Dental Assistant students from Mountain Empire Community College will develop PSAs after receiving training about HPV vaccination and health communication. These PSAs will be used in a social marketing campaign executed through a regional transportation system managed by Mountain Empire Older Citizens. Specifically, the trial's aims are three-fold: assess the intervention's impact on community members' and students' HPV vaccine hesitancy (Aim 1) and perceptions and actions related to HPV vaccination (Aim 2) and evaluate other feasibility indicators at the community-, student-, organizational-, and process levels (Aim 3). The research team will use a concurrent mix-methods approach to assess feasibility indicators. Aims will be assessed using surveys, focus groups, meeting minutes, and implementation records. Data will be analyzed using descriptive and inferential statistics and content coding. Determination of the intervention's feasibility will consider the achievement benchmarks for feasibility indicators individually and collectively. Data will be used to inform refinement and future testing of Appalachian Voices for Health.

Study Overview

• Status: Recruiting
• Conditions: Human Papillomavirus Infection; Vaccination Hesitancy
• Intervention / Treatment: Behavioral: PSA Development; Behavioral: HPV vaccination focused social marketing campaign

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen J Porter, PhD RD; Phone Number: 434-270-6599; Email: kjp9c@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Kathleen Porter; Phone Number: 434-270-6599; Email: kjp9c@virginia.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 18 or older
• enrolled as a student in one of the regional community college's health sciences programs (Phase 1 only)
• ride the regional health services focused non-profit's rideshare buses or view their social media during one or more of the three survey periods (Phase 2 only)
• work for either the regional community college or non-profit AND were involved in supporting the execution of the study components within their organization.

Exclusion Criteria:

• Under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PSA Development (Phase 1)	Behavioral: PSA Development; Health sciences students from a regional community college in Appalachian Virginia will be asked to to develop and submit a public service announcement (PSA) and to watch virtual training webinars that support the development of the PSAs. They will also be asked to complete surveys at three time points: before the PSA contest starts, after the PSA contest ends, and upon submitting a PSA.
Experimental: Social Marketing Campaign (Phase 2)	Behavioral: HPV vaccination focused social marketing campaign; Community members who use a regional health services focused non-profits rideshare buses and/or view their social media pages will be exposed to a 12-week social marketing campaign that uses PSAs developed in Phase 1. Community members will also complete surveys at three time points: before the start of the social marketing campaign, during the social marketing campaign, and after the social marketing campaign.
No Intervention: Organizational Stakeholders; Organizational stakeholders from organizations involved in Phase 1 and 2 will take part in a focus group after their respective phases have been completed to learn more about their experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccination hesitancy scale modified for the HPV vaccine (VHS-HPV)	validated instrument; 9 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy	Change in community members' self-reported VHS-HPV score pre-post intervention (14 week period / Phase 2)
Vaccination hesitancy scale modified for the HPV vaccine (VHS-HPV)	validated instrument; 9 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy	Change in Health Sciences students' self-reported VHS-HPV score pre-post intervention (6 week period / Phase 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccination hesitancy scale (VHS)	validated instrument; 10 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy	Change in community members' self-reported VHS score pre-post intervention (14 week period / Phase 2)
Vaccination hesitancy scale (VHS)	validated instrument; 10 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy	Change in Health Science students' self-reported VHS score pre-post intervention (6 week period / Phase 1)

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Papillomavirus Infections
• Other Study ID Numbers: SBS-5519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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