A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men
Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HPV Vaccine Acceptability
Intervention: HPV vaccine acceptability (Behavioral)
Phase: Phase 4
Status: Completed
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s): Manoj Sharma, Ph.D., Principal Investigator, Affiliation: University of Cincinnati Rebecca Lee, Ph.D., Study Director, Affiliation: University of Cincinnati Purvi Mehta, MS, Study Director, Affiliation: University of Cincinnati
Summary
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.
Clinical Details
Official title: Designing and Evaluating a Health Belief Model Based Intervention to Increase Intent of HPV Vaccination Among College Men: Use of Qualitative and Quantitative Methodologies
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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 VaccineChange 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)
Secondary outcome: Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPVChange From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine 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 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 Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 25 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Manoj Sharma, Cincinnati, Ohio 45221-0068, United States
Additional Information
Manufactures HPV vaccine
Starting date: September 2011
Last updated: January 30, 2013
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