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

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ClinicalTrials.gov Identifier: NCT02464358
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Dean Cruess, University of Connecticut

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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Behavioral: IMB Intervention Group Behavioral: Attention Control Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : December 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: IMB Intervention Group

The IMB group received an HPV Vaccination Information Statement (VIS) often given to individuals prior to vaccination. In addition, they received the following:

  1. Additional educational content related to HPV, Cervical Cancer, and HPV vaccination,
  2. Motivational content to help identify and problem-solve benefits and barriers to vaccination,
  3. Skills-building content, including brief communication skills training and ways to access the vaccine.
Behavioral: IMB Intervention Group
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.
Other Name: IMB Based Educational Program

Active Comparator: Attention Control Group
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.
Behavioral: Attention Control
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 Measures :
  1. HPV, Cervical Cancer, and HPV Vaccine Knowledge Questionnaire [ Time Frame: One month ]
    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.

  2. Vaccination Motivation Questionnaire [ Time Frame: One month ]
    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.

  3. Behavioral Skills Questionnaire [ Time Frame: One Month ]
    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 :
  1. Behavioral uptake of the HPV vaccine Questionnaire [ Time Frame: One month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrollment in a psychology course at the University of Connecticut

Exclusion Criteria:

  • Completion of the HPV vaccination series

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464358


Sponsors and Collaborators
University of Connecticut
Investigators
Principal Investigator: Dean G Cruess, Ph.D. University of Connecticut
Study Director: Giselle K Perez, Ph.D. Massachusetts General Hospital

Responsible Party: Dean Cruess, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT02464358     History of Changes
Other Study ID Numbers: H11-272
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by Dean Cruess, University of Connecticut:
HPV

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs