NCT05860725

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

February 28, 2023

Last Update Submit

May 8, 2024

Conditions

Outcome Measures

Primary Outcomes (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 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 Outcomes (2)

  • Vaccination hesitancy scale (VHS)

    Change in community members' self-reported VHS score pre-post intervention (14 week period / Phase 2)

  • Vaccination hesitancy scale (VHS)

    Change in Health Science students' self-reported VHS score pre-post intervention (6 week period / Phase 1)

Study Arms (3)

PSA Development (Phase 1)

EXPERIMENTAL
Behavioral: PSA Development

Social Marketing Campaign (Phase 2)

EXPERIMENTAL
Behavioral: HPV vaccination focused social marketing campaign

Organizational Stakeholders

NO INTERVENTION

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.

Interventions

PSA DevelopmentBEHAVIORAL

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.

PSA Development (Phase 1)

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.

Social Marketing Campaign (Phase 2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Papillomavirus InfectionsVaccination Hesitancy

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Kathleen J Porter, PhD RD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 28, 2023

First Posted

May 16, 2023

Study Start

March 13, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations