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

Primary Purpose

Human Papillomavirus Infection, Vaccination Hesitancy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PSA Development
HPV vaccination focused social marketing campaign
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Papillomavirus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

PSA Development (Phase 1)

Social Marketing Campaign (Phase 2)

Organizational Stakeholders

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 28, 2023
Last Updated
May 5, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05860725
Brief Title
Feasibility Trial of a Multi-level Media Production and Social Marketing Campaign to Reduce HPV Vaccine Hesitancy
Official Title
Appalachian Voices for Health - Feasibility Trial of a Multi-level Media Production and Social Marketing Campaign to Reduce HPV Vaccine Hesitancy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infection, Vaccination Hesitancy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PSA Development (Phase 1)
Arm Type
Experimental
Arm Title
Social Marketing Campaign (Phase 2)
Arm Type
Experimental
Arm Title
Organizational Stakeholders
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PSA Development
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HPV vaccination focused social marketing campaign
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vaccination hesitancy scale modified for the HPV vaccine (VHS-HPV)
Description
validated instrument; 9 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy
Time Frame
Change in community members' self-reported VHS-HPV score pre-post intervention (14 week period / Phase 2)
Title
Vaccination hesitancy scale modified for the HPV vaccine (VHS-HPV)
Description
validated instrument; 9 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy
Time Frame
Change in Health Sciences students' self-reported VHS-HPV score pre-post intervention (6 week period / Phase 1)
Secondary Outcome Measure Information:
Title
Vaccination hesitancy scale (VHS)
Description
validated instrument; 10 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy
Time Frame
Change in community members' self-reported VHS score pre-post intervention (14 week period / Phase 2)
Title
Vaccination hesitancy scale (VHS)
Description
validated instrument; 10 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy
Time Frame
Change in Health Science students' self-reported VHS score pre-post intervention (6 week period / Phase 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen J Porter, PhD RD
Phone
434-270-6599
Email
kjp9c@virginia.edu
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Porter
Phone
434-270-6599
Email
kjp9c@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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