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An Information-Motivation-Behavioral Skills (IMB) Intervention to Promote Human Papillomavirus Vaccination Among Women

Primary Purpose

Human Papillomavirus Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IMB Intervention Group
Attention Control
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papillomavirus Infection focused on measuring HPV

Eligibility Criteria

18 Years - 26 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Enrollment in a psychology course at the University of Connecticut

Exclusion Criteria:

  • Completion of the HPV vaccination series

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    IMB Intervention Group

    Attention Control Group

    Arm Description

    The IMB group received an HPV Vaccination Information Statement (VIS) often given to individuals prior to vaccination. In addition, they received the following: Additional educational content related to HPV, Cervical Cancer, and HPV vaccination, Motivational content to help identify and problem-solve benefits and barriers to vaccination, Skills-building content, including brief communication skills training and ways to access the vaccine.

    The attention control group also received an HPV Vaccination Information Statement (VIS) often given to individuals prior to vaccination. In addition, to maintain consistency with the treatment's presentation format, participants watched a set of short video clips encompassing aspects of women's general and sexual health.

    Outcomes

    Primary Outcome Measures

    HPV, Cervical Cancer, and HPV Vaccine Knowledge Questionnaire
    Consistent with studies based on the IMB model,, participants were assessed on their level of knowledge regarding information about HPV, the HPV vaccine, and cervical cancer.
    Vaccination Motivation Questionnaire
    Consistent with studies based on the IMB model, motivation to get vaccinated was assessed through five questionnaires to measure different aspects of motivation: perceived motivation, attitudes related to getting vaccinated, perceived social norms to getting vaccinated, behavioral intentions, and perceived risk for HPV/cervical cancer.
    Behavioral Skills Questionnaire
    Consistent with studies based on the IMB model, participants' belief and confidence in their ability to get vaccinated were assessed with questions adapted from these studies.

    Secondary Outcome Measures

    Behavioral uptake of the HPV vaccine Questionnaire

    Full Information

    First Posted
    June 3, 2015
    Last Updated
    June 4, 2015
    Sponsor
    University of Connecticut
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02464358
    Brief Title
    An Information-Motivation-Behavioral Skills (IMB) Intervention to Promote Human Papillomavirus Vaccination Among Women
    Official Title
    The Impact of an Information-Motivation-Behavioral Skills (IMB) Based Educational Intervention to Improve Gardasil Use in a Population of Undergraduate Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Connecticut

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. This study explored the utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV vaccination knowledge, motivation, and behavioral skills among college aged women.
    Detailed Description
    HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. This study explored the utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV vaccination knowledge, motivation, and behavioral skills among college aged women. Methods: Participants were randomly assigned to a single-session intervention or attention-control arm and were assessed at pre-intervention, post-intervention, and at 1-month follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Papillomavirus Infection
    Keywords
    HPV

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IMB Intervention Group
    Arm Type
    Experimental
    Arm Description
    The IMB group received an HPV Vaccination Information Statement (VIS) often given to individuals prior to vaccination. In addition, they received the following: Additional educational content related to HPV, Cervical Cancer, and HPV vaccination, Motivational content to help identify and problem-solve benefits and barriers to vaccination, Skills-building content, including brief communication skills training and ways to access the vaccine.
    Arm Title
    Attention Control Group
    Arm Type
    Active Comparator
    Arm Description
    The attention control group also received an HPV Vaccination Information Statement (VIS) often given to individuals prior to vaccination. In addition, to maintain consistency with the treatment's presentation format, participants watched a set of short video clips encompassing aspects of women's general and sexual health.
    Intervention Type
    Behavioral
    Intervention Name(s)
    IMB Intervention Group
    Other Intervention Name(s)
    IMB Based Educational Program
    Intervention Description
    Participants in the IMB group received information specific to HPV, cervical cancer, and the HPV vaccine. This information was delivered in a group setting, and it was delivered via a PowerPoint presentation that included short video clips.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Attention Control
    Intervention Description
    Participants in the attention control arm watched a PowerPoint that contained a series of short video clips encompassing aspects of women's general and sexual health. This was also conducted in a group setting.
    Primary Outcome Measure Information:
    Title
    HPV, Cervical Cancer, and HPV Vaccine Knowledge Questionnaire
    Description
    Consistent with studies based on the IMB model,, participants were assessed on their level of knowledge regarding information about HPV, the HPV vaccine, and cervical cancer.
    Time Frame
    One month
    Title
    Vaccination Motivation Questionnaire
    Description
    Consistent with studies based on the IMB model, motivation to get vaccinated was assessed through five questionnaires to measure different aspects of motivation: perceived motivation, attitudes related to getting vaccinated, perceived social norms to getting vaccinated, behavioral intentions, and perceived risk for HPV/cervical cancer.
    Time Frame
    One month
    Title
    Behavioral Skills Questionnaire
    Description
    Consistent with studies based on the IMB model, participants' belief and confidence in their ability to get vaccinated were assessed with questions adapted from these studies.
    Time Frame
    One Month
    Secondary Outcome Measure Information:
    Title
    Behavioral uptake of the HPV vaccine Questionnaire
    Time Frame
    One month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Enrollment in a psychology course at the University of Connecticut Exclusion Criteria: Completion of the HPV vaccination series
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dean G Cruess, Ph.D.
    Organizational Affiliation
    University of Connecticut
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Giselle K Perez, Ph.D.
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Information-Motivation-Behavioral Skills (IMB) Intervention to Promote Human Papillomavirus Vaccination Among Women

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