- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464358
An Information-Motivation-Behavioral Skills (IMB) Intervention to Promote Human Papillomavirus Vaccination Among Women
The Impact of an Information-Motivation-Behavioral Skills (IMB) Based Educational Intervention to Improve Gardasil Use in a Population of Undergraduate Women
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Enrollment in a psychology course at the University of Connecticut
Exclusion Criteria:
- Completion of the HPV vaccination series
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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:
|
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 Names:
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One month
|
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.
|
One month
|
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.
|
One Month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Behavioral uptake of the HPV vaccine Questionnaire
Time Frame: One month
|
One month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dean G Cruess, Ph.D., University of Connecticut
- Study Director: Giselle K Perez, Ph.D., Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H11-272
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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