Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sharma Manoj, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01431079
First received: September 3, 2011
Last updated: January 30, 2013
Last verified: January 2013

September 3, 2011
January 30, 2013
September 2011
July 2012   (final data collection date for primary outcome measure)
  • Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions the Number of Participants Who Have Taken the HPV Vaccine [ Time Frame: Post intervention and up to 3 months after the interventions ] [ Designated as safety issue: No ]
    Before, after and one to three month following the health belief model based educational intervention and knowledge-based educational intervention the participants will be asked if they have taken the first dose of HPV vaccine and changes noted.
  • Change From Baseline to Post Intervention to Follow-up up to 3 Months After the Interventions the Number of Participants Who Intend to Take HPV Vaccine Using HPV Intent Scale (Possible Range 0-4 Likert Units) [ Time Frame: Post intervention and up to 3 months after the intervention ] [ Designated as safety issue: No ]

    Before the interventions, post test after the interventions and follow-up 1 to 3 months after the interventions (health belief model based and knowledge based) participants will be asked about their intent to take the HPV vaccine on a scale of 0-4 Likert units and changes noted.

    Posttest was conducted immediately after the intervention. Minimum score = 0 indicating no intent to take vaccine; Maximum score = 4 indicating strong intent to take vaccine. Scale was a single item scale.

  • Change From Baseline to One Month After the Interventions the Number of Participants Who Have Taken the HPV Vaccine [ Time Frame: 1 month after the interventions ] [ Designated as safety issue: No ]
    Before, after and one month following the health belief model based educational intervention and knowledge-based educational intervention the participants will be asked if they have taken the first dose of HPV vaccine and changes noted.
  • Change from baseline to 1 month after the interventions the number of participants who intend to take HPV vaccine [ Time Frame: 1 month after the interventions ] [ Designated as safety issue: No ]
    Before the interventions, after the interventions and 1 month after the interventions (health belief model based and knowledge based) participants will be asked about their intent to take the HPV vaccine and changes noted.
Complete list of historical versions of study NCT01431079 on ClinicalTrials.gov Archive Site
  • Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV [ Time Frame: Post interventions and up to 3 months after the interventions ] [ Designated as safety issue: No ]

    Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived susceptibility for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived susceptibility for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.

    Difference between posttest and pre-test was done. This value was then used to run the multiple regressions.

  • Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV [ Time Frame: Post interventions and up to 3 months after the intervention ] [ Designated as safety issue: No ]

    Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived severity for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived severity for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.

    Difference between posttest and pre-test was done. This value was then used to run the multiple regressions.

  • Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine [ Time Frame: post intervention and up to 3 months after the interventions ] [ Designated as safety issue: No ]

    Before the interventions, after the interventions and one month following the interventions the health belief model construct of Perceived benefits of HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived benefits of HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0-not very likely and 16- very likely). The subscale has acceptable validity and reliability.

    Difference between posttest and pre-test was done. This value was then used to run the multiple regressions.

  • Change From Baseline to Post Test After the Interventions to Follow-up (up to 3 Months) in the Score of Perceived Barriers to Receiving HPV Vaccine [ Time Frame: post interventions and up to 3 months after the intervention ] [ Designated as safety issue: No ]

    Before the interventions, post test after the interventions following the interventions the health belief model construct of perceived barriers to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived barriers for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.

    A difference between post-test and pre-test were taken to obtain the score. This score was then used in the regression.

  • Change From Baseline to After the Interventions to Follow-up up to 3 Months After the Interventions in Score of Cues to Action to Receiving HPV Vaccine [ Time Frame: Post interventions and up to three months after the intervention ] [ Designated as safety issue: No ]

    Before the interventions, and after the interventions and up to 3 months after the interventions the health belief model construct of cues to action to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Cues to action to receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0- not at all likely to 16-very likely). The subscale has acceptable validity and reliability.

    Difference between post and pre-test were used to obtain a change score. This score was used for regressions.

  • Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine [ Time Frame: Post interventions and up to 3 months follow-up ] [ Designated as safety issue: No ]

    Before the interventions and after the interventions the health belief model construct of self-efficacy for receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Self-efficacy for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.

    The difference between post and pre-test was taken to determine a change score. This score was then used for regressions.

  • Change from baseline to one month after the interventions in score of perceived susceptibility for HPV [ Time Frame: 1 month after the interventions ] [ Designated as safety issue: No ]
    Before the interventions, after the interventions and one month following the interventions the health belief model construct of perceived susceptibility for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived susceptibility for HPV will be measured as a summative score on a four item Likert subscale with a range of 0 to 12. The subscale has acceptable validity and reliability.
  • Change from baseline to one month after the interventions in score for perceived severity for HPV [ Time Frame: 1 month after the interventions ] [ Designated as safety issue: No ]
    Before the interventions, after the interventions and one month following the interventions the health belief model construct of perceived severity for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived severity for HPV will be measured as a summative score on a four item Likert subscale with a range of 0 to 12. The subscale has acceptable validity and reliability.
  • Change from baseline to one month after the interventions in score of perceived benefits of HPV vaccine [ Time Frame: 1 month after the interventions ] [ Designated as safety issue: No ]
    Before the interventions, after the interventions and one month following the interventions the health belief model construct of Perceived benefits of HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived benefits of HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 9. The subscale has acceptable validity and reliability.
  • Change from baseline to one month after the interventions in the score of perceived barriers to receiving HPV vaccine [ Time Frame: 1 month after the interventions ] [ Designated as safety issue: No ]
    Before the interventions, after the interventions and one month following the interventions the health belief model construct of perceived barriers to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived barriers for receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 12. The subscale has acceptable validity and reliability.
  • Change from baseline to one month after the interventions in score of cues to action to receiving HPV vaccine [ Time Frame: 1 month after the interventions ] [ Designated as safety issue: No ]
    Before the interventions, after the interventions and one month following the interventions the health belief model construct of cues to action to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Cues to action to receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 12. The subscale has acceptable validity and reliability.
  • Change from baseline to one month after the interventions in score of self-efficacy for receiving HPV vaccine [ Time Frame: 1 month after the interventions ] [ Designated as safety issue: No ]
    Before the interventions, after the interventions and one month following the interventions the health belief model construct of self-efficacy for receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Self-efficacy for receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 12. The subscale has acceptable validity and reliability.
Not Provided
Not Provided
 
A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men
Designing and Evaluating a Health Belief Model Based Intervention to Increase Intent of HPV Vaccination Among College Men: Use of Qualitative and Quantitative Methodologies

The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV) vaccine acceptability among college men based on the Health Belief Model through focus groups, (2) triangulate focus group results with a prior quantitative study in developing an intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3) test the efficacy of the above intervention based on the Health Belief Model by comparing it to a knowledge-based intervention. Approximately five focus groups with ten participants in each group with college students in the ages 18-25 years will be conducted at a large Midwestern University for the qualitative piece. Data will be analyzed for categories and triangulated with previous study to develop a theory based intervention. For the quantitative piece a randomized controlled design with 45 participants in each arm (theory based intervention and knowledge based intervention) will be implemented.

Up to this date, there was a lack of qualitative research on vaccine acceptability among men and theory-based interventions that promote HPV vaccination among men. A few studies have been conducted with parents and physicians regarding HPV vaccination with girls, and a few regarding women's awareness and acceptability. Results indicated increasing awareness of HPV, informing costs and benefits associated with the vaccine, and perceived susceptibility. Based on this information, it is crucial to obtain a further understanding of knowledge, awareness, and predictors related to HPV and its vaccination in men. Information obtained can be utilized in developing an intervention to increase intentions of taking the HPV vaccine. Refining results will lead to a standardization of an intervention that can be implemented across college campuses.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
HPV Vaccine Acceptability
Behavioral: HPV vaccine acceptability
One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
  • Experimental: Health belief model based education
    This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
    Intervention: Behavioral: HPV vaccine acceptability
  • Active Comparator: Knowledge-based education
    This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.
    Intervention: Behavioral: HPV vaccine acceptability
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
August 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males
  • English speaking
  • 18-25 years
  • Undergraduate or graduate student at the University of Cincinnati

Exclusion Criteria:

  • Females
  • Under 18 years, or above 25 years
  • Non- English speaking individuals
  • Non-university attending students
  • If already received HPV vaccination
Male
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01431079
11083108, 39991
No
Sharma Manoj, University of Cincinnati
University of Cincinnati
Not Provided
Principal Investigator: Manoj Sharma, Ph.D. University of Cincinnati
Study Director: Rebecca Lee, Ph.D. University of Cincinnati
Study Director: Purvi Mehta, MS University of Cincinnati
University of Cincinnati
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP