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

May 8, 2024 updated by: Kathleen Porter, Phd, RD, University of Virginia

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vaccination hesitancy scale modified for the HPV vaccine (VHS-HPV)
Time Frame: 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
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)
Time Frame: 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
Change in Health Sciences students' self-reported VHS-HPV score pre-post intervention (6 week period / Phase 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vaccination hesitancy scale (VHS)
Time Frame: 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
Change in community members' self-reported VHS score pre-post intervention (14 week period / Phase 2)
Vaccination hesitancy scale (VHS)
Time Frame: 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
Change in Health Science students' self-reported VHS score pre-post intervention (6 week period / Phase 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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