NCT02464358

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

10 months

First QC Date

June 3, 2015

Last Update Submit

June 4, 2015

Conditions

Keywords

HPV

Outcome Measures

Primary Outcomes (3)

  • 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.

    One month

  • 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.

    One month

  • 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.

    One Month

Secondary Outcomes (1)

  • Behavioral uptake of the HPV vaccine Questionnaire

    One month

Study Arms (2)

IMB Intervention Group

EXPERIMENTAL

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

Attention Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: IMB Based Educational Program
IMB Intervention Group

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.

Attention Control Group

Eligibility Criteria

Age18 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Enrollment in a psychology course at the University of Connecticut

You may not qualify if:

  • Completion of the HPV vaccination series

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dean G Cruess, Ph.D.

    University of Connecticut

    PRINCIPAL INVESTIGATOR
  • Giselle K Perez, Ph.D.

    Massachusetts General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 8, 2015

Study Start

December 1, 2011

Primary Completion

October 1, 2012

Study Completion

December 1, 2013

Last Updated

June 8, 2015

Record last verified: 2015-06