PreTeenVax Evaluation

August 7, 2018 updated by: Robert Bednarczyk, Emory University

A Practice-Provider-Parent-Adolescent Intervention to Increase HPV Vaccination

The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion toolkit implemented in the pediatric healthcare setting on increasing the likelihood that adolescents in Georgia will initiate and complete the Human Papillomavirus (HPV) vaccine series. Secondary research aims include assessing the impact of the comprehensive toolkit on 1) patient and parent knowledge and attitudes regarding HPV vaccine, and 2) provider recommendation of HPV vaccine for males and females in the recommended age range (11-12 years). The intervention toolkit will include evidence-based components aimed at the practice-level, provider-level and parent-level that will be tested through a cluster-randomized trial design. The primary hypothesis is that implementation of the comprehensive vaccine promotion toolkit in the pediatric health care setting will increase the likelihood that an adolescent receives initiates HPV vaccination.

At the initial visit, parents of adolescent patients at participating pediatric practices will complete a brief questionnaire assessing their knowledge, attitudes, and beliefs about adolescent health, including protection against infectious diseases during adolescence. The parents will be contacted again three months later to complete a short follow-up interview on the general health of their adolescent child, immunization status, and attitudes regarding vaccination.

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.

Detailed Description

Since the introduction of HPV vaccine, there have been a number of studies examining attitudes and barriers related to HPV vaccine uptake among adolescent and young adult women, parents, and healthcare providers. Through these surveys, a number of distinct themes regarding reasons for not taking the HPV vaccine have emerged, including lack of provider recommendation, lack of awareness about the vaccine and the need for vaccination, concerns about vaccine effectiveness, concerns about vaccine safety, the potential of a vaccine against a sexually transmitted infection to increase promiscuity, cost of the vaccine doses, and the lack of routine adolescent well-care visits. However, many of these studies have used endpoints related to HPV vaccine knowledge or intention to vaccinate rather than actual vaccination uptake. Interventions that use endpoints related to vaccination uptake rather than knowledge or intention to vaccinate, as well as those that address multiple levels of the healthcare decision making process, will be crucial in addressing routine immunization coverage among adolescents. At the end of the evaluation of this intervention package, the researchers of this study hope to have identified a comprehensive and easily scalable "shelf-ready" toolkit aimed at increasing uptake of vaccines that are indicated during adolescence. If successful, this package could easily be implemented on a national level.

In the evaluation study, the researchers will use a cluster-randomized trial design to test whether exposure to the intervention package increases the likelihood of vaccine receipt by an adolescent in a practice randomized to receive the intervention package compared to an adolescent in a practice randomized to the control (standard of care) arm. Participating pediatric practices will be pair-matched based on overall adolescent patient load and historical HPV vaccine uptake and pairs will be randomized to one of two study arms:

  1. Intervention arm: The pediatric practices randomized to this arm will receive the comprehensive adolescent vaccine promotion package. Practice physicians and staff will be familiarized with each component, and practices will be instructed to implement each vaccine-promotion component to the best of their ability.
  2. Control arm: The pediatric practices randomized to the control arm will not receive the comprehensive vaccine promotion package and will instead be instructed to continue offering their standard adolescent vaccination promotion practices to adolescent patients.

Parents of eligible adolescents at participating practices will be given the opportunity to take part in this study. At the initial visit, parents of adolescent patients will complete a brief questionnaire assessing their knowledge, attitudes, and beliefs about adolescent health, including protection against infectious diseases during adolescence. The parents will be contacted again three months later to complete a short follow-up interview on the general health of their adolescent child, immunization status, and attitudes regarding vaccination.

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.
168

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 Locations

  • United States
    • Georgia
      • Canton, Georgia, United States, 30114
        • DV Pediatrics
      • Duluth, Georgia, United States, 30097
        • Crescent Pediatrics
      • Lawrenceville, Georgia, United States, 30046
        • Lawrenceville Pediatrics - Lawrenceville Office
      • Lithia Springs, Georgia, United States, 30122
        • West Atlanta Pediatrics
      • Loganville, Georgia, United States, 30052
        • Lawrenceville Pediatrics - Loganville Office
      • Stone Mountain, Georgia, United States, 30087
        • Northlake Pediatric Associates

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

11 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Parents are enrolled into the study based on their children meeting age and prior vaccination requirements.

Inclusion Criteria:

  • Adolescent males and females aged 11-12 years and their parents
  • No previous receipt of any HPV vaccine dose by the adolescent

Exclusion Criteria:

  • Not English speaking (adolescents and parents)

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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: Comprehensive Vaccine Promotion Package
The pediatric practices randomized to this arm will receive the comprehensive adolescent vaccine promotion package. Practice physicians and staff will be familiarized with each component, and practices will be instructed to implement each vaccine-promotion component to the best of their ability.
Behavioral: Comprehensive Vaccine Promotion Package

Practice-level components: Periodic feedback on adolescent immunization coverage. Assistance with implementing and utilizing standing orders for adolescent vaccine administration in the practice, utilizing standardized materials as provided by the Centers for Disease Control and Prevention and the Immunization Action Coalition. Identification of an immunization champion to facilitate immunization activities in the practice. Linkage to peer-to-peer training on adolescent vaccination through the Georgia Educating Providers In their Communities (EPIC) program.

Provider-level components: Providers will receive standardized talking points, vaccine promotion scripts and answers to frequently asked questions, with training on how best to discuss, recommend and answer questions about vaccines.

Patient/Parent-level components: An iPad tablet-based educational presentation will be provided for parents while they are waiting with their adolescent child in the examination room.
NO_INTERVENTION: Standard Vaccination Promotion
The pediatric practices randomized to the control arm will not receive the comprehensive vaccine promotion package and will instead be instructed to continue offering their standard adolescent vaccination promotion practices to adolescent patients.

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
Initiation of HPV vaccine by adolescents
Time Frame: Month 3 Follow-Up

During the follow-up interview, parents are asked if their child received the HPV vaccine during the visit with their pediatrician when they enrolled in this study. Possible responses are:

  • Yes, they received a dose of this vaccine
  • No, the received a dose of this vaccine before that visit
  • No, but they received a dose of this vaccine at a later visit
  • No, they have not received this vaccine
  • Don't know
Month 3 Follow-Up

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
Vaccine Confidence Scale score
Time Frame: Month 3 Follow-Up
Parental knowledge, attitudes, and beliefs about adolescent vaccination will be measured with the Vaccine Confidence Scale. The Vaccine Confidence Scale is an 8-item survey where respondents indicate the degree of their agreement with statements relating to vaccines (for example "Vaccines are safe"). Responses are on a scale of 0 to 10 where 0 = "Strongly Disagree", 5 = "Neutral", and 10 = "Strongly Agree". After reverse-coding certain items on the scale, the mean score of all responses serves as the total score. Total scores can range from 0 to 10 where higher scores indicate increased knowledge, attitudes, and beliefs regarding adolescent vaccination.
Month 3 Follow-Up
Provider perception of the intervention
Time Frame: At the end of the study (about 2 years)
At the conclusion of the study period, the perceptions of healthcare providers and practice managers in the intervention practices regarding the intervention packages will be evaluated. Providers will respond to questions to share their perceptions on the extent to which the intervention was fully implemented (e.g., was querying of GRITS and the electronic medical record done consistently), and perceptions on the ease and helpfulness of the intervention components (e.g., talking points, printed materials) in facilitating conversations about HPV vaccination leading to vaccine receipt.
At the end of the study (about 2 years)

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.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

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.
June 14, 2017

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.
July 31, 2018

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.
July 31, 2018

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).
June 12, 2017

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.
June 12, 2017

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.
June 14, 2017

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.
August 8, 2018

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.
August 7, 2018

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.
August 1, 2018

More Information

Terms related to this study

Keywords

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.
  • IRB00090382
  • K01AI106961 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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