Testing Messages to Promote HPV Vaccination

January 24, 2022 updated by: University of Colorado, Denver

TESTING MESSAGES TO PROMOTE USE OF AN HPV ONLINE INTERVENTION

Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Hispanic women have the highest rates of HPV-related cervical cancer compared to all other groups in the U.S. Previous research has delineated several unique barriers to HPV vaccination among Hispanic women, suggesting that interventions that focus on addressing these barriers may improve HPV vaccination compliance in this population. To address some of these unique barriers, an online tailored messaging intervention was developed and tested. Initial analyses demonstrate that participants exposed to an online intervention demonstrated higher intentions to vaccinate for HPV after viewing the informational materials. The next phase of the project will be comprised of promoting use of the online intervention to the general public through the use of theory-based, pretested messages delivered via advertisements on Facebook and Twitter. Specifically, messages will be targeted based on differences between Hispanic parents of adolescents and Hispanic young adults. Previous research has explored the use of the Extended Parallel Processing Model as a theory to guide messages designed to promote health behaviors. The current study extends this work in the area of HPV prevention. Specifically, it seeks to examine the use of this theory as a means to stimulate information seeking behavior in the form of use of the previously developed online intervention that provides information about HPV. We also hope to make a significant contribution to research demonstrating the importance of targeting messages based on differences in population characteristics. Additionally, this study seeks to build on research examining the use of social media sites as a means for implementing health interventions and promoting positive health outcomes. Ultimately, the current study seeks to improve both the HPV vaccination decision-making process and HPV vaccination rates. If this was achieved among the Hispanic population it could substantially decrease disparities in cervical cancer and other HPV-related diseases.

Study Overview

Status

Status

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

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 (Actual)

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.
784

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For parents eligibility criteria were being: 1) of Hispanic or Latino origin, 2) 18 years or older, 3) a parent or guardian of a child ages 11-17 who had not been vaccinated for HPV.
  • For young adults eligibility were being: 1) of Hispanic or Latino origin, 2) 18-26 years of age (vaccine eligibility at the time of data collection, and 3) having not been vaccinated for HPV.

Exclusion Criteria:

  • Being under 18 years of age
  • Not identifying as Hispanic or Latino
  • For parents, having no children ages 11-17 or having only children already vaccinated for HPV
  • For young adults, having already been vaccinated for HPV or no longer being eligible due to age (>26)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

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: Cancer Messages - Young Adults
Messages providing information about the use of HPV vaccines to prevent cancer.
Behavioral: Health Messages
Brief messages providing information about the effectiveness of HPV vaccines. Messages included embedded links where participants could find more information.
Experimental: Cancer Messages - Parents of Adolescents
Messages providing information about the use of HPV vaccines for their adolescent children to prevent cancer.
Behavioral: Health Messages
Brief messages providing information about the effectiveness of HPV vaccines. Messages included embedded links where participants could find more information.
Experimental: Genital Wart Messages - Young Adults
Messages providing information about the use of HPV vaccines to prevent genital warts.
Behavioral: Health Messages
Brief messages providing information about the effectiveness of HPV vaccines. Messages included embedded links where participants could find more information.
Experimental: Genital Wart Messages - Parents of Adolescents
Messages providing information about the use of HPV vaccines or their adolescent children to prevent genital warts.
Behavioral: Health Messages
Brief messages providing information about the effectiveness of HPV vaccines. Messages included embedded links where participants could find more information.
Active Comparator: Control Messages - Young Adults
Messages providing information about HPV vaccines that did not mention prevention of other diseases or conditions.
Behavioral: Health Messages
Brief messages providing information about the effectiveness of HPV vaccines. Messages included embedded links where participants could find more information.
Active Comparator: Control Messages - Parents of Adolescents
Messages providing information about HPV vaccines for their adolescent children that did not mention prevention of other diseases or conditions.
Behavioral: Health Messages
Brief messages providing information about the effectiveness of HPV vaccines. Messages included embedded links where participants could find more information.

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
Intention to Seek Information - 1
Time Frame: 1 day (one time while participants viewed the brief intervention.)
Hyperlinks were embedded in intervention messages where participants were told they could find more information about HPV. A click on the link was considered intention to seek information. Not clicking on the link was considered no intention to seek information.
1 day (one time while participants viewed the brief intervention.)
Intention to Seek Information - 2
Time Frame: Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention.
Intention to Seek Information survey items measure participants likelihood to seek information about HPV. Survey items included a Yes-No response to the statement "I intend to look for more information about the HPV vaccination within the next 30 days." Those who answer "Yes" were then shown a series of questions prompting them to indicate their likelihood of seeking more information about the HPV vaccination from their "doctor or healthcare provider," "a friend of family member," "the Internet," and "other sources." Responses were measured on a 7-point Likert-type scale that ranged from Very Likely to Very Unlikely. Those who answered "No" were shown the question "Which of the following best represents your reason for not seeking information about the HPV vaccine?". Responses included 1) low interest in the topic, 2) already well informed on the topic, 3) topic is not relevant to me, and 4) information on this topic is upsetting to me.
Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention.

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
Intention to Vaccinate for HPV
Time Frame: Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention
Intention to Vaccinate for HPV measures participants willingness to vaccinate for HPV. It was measured using a single item stating "I intend to get vaccinated against HPV within the next 6 months." Reponses were measured on a 7-point scale ranging from "Strongly agree" to "Strongly disagree."
Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention

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 Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 18, 2016

Primary Completion (Actual)

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.
March 5, 2017

Study Completion (Actual)

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.
March 5, 2017

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).
December 17, 2021

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.
January 24, 2022

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.
January 25, 2022

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.
January 25, 2022

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.
January 24, 2022

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.
January 1, 2022

More Information

Terms related to this study

Keywords

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.
  • 16-0447

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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