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

Sponsor
University of Virginia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05860725
Collaborator
(none)
220
1
3
10.6
20.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PSA Development
  • Behavioral: HPV vaccination focused social marketing campaign
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Appalachian Voices for Health - Feasibility Trial of a Multi-level Media Production and Social Marketing Campaign to Reduce HPV Vaccine Hesitancy
Actual Study Start Date :
Mar 13, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Vaccination hesitancy scale modified for the HPV vaccine (VHS-HPV) [Change in community members' self-reported VHS-HPV score pre-post intervention (14 week period / Phase 2)]

    validated instrument; 9 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy

  2. Vaccination hesitancy scale modified for the HPV vaccine (VHS-HPV) [Change in Health Sciences students' self-reported VHS-HPV score pre-post intervention (6 week period / Phase 1)]

    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

  1. Vaccination hesitancy scale (VHS) [Change in community members' self-reported VHS score pre-post intervention (14 week period / Phase 2)]

    validated instrument; 10 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy

  2. Vaccination hesitancy scale (VHS) [Change in Health Science students' self-reported VHS score pre-post intervention (6 week period / Phase 1)]

    validated instrument; 10 items on a response scale of 1-5 (strongly disagree to strongly agree) with higher scores indicating greater hesitancy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Charlottesville Virginia United States 22903

Sponsors and Collaborators

  • University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kathleen Porter, Phd, RD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier:
NCT05860725
Other Study ID Numbers:
  • SBS-5519
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2023