Clinical trial NCT01431079: A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HPV Vaccine Acceptability
Keywords: HPV
College men
HPV vaccine
Health belief model
HPV vaccine acceptance
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2011-09-09
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
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
timeFrame: Post intervention and up to 3 months after the interventions
measure: 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)
timeFrame: Post intervention and up to 3 months after the intervention
Secondary outcomes:
measure: Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV
timeFrame: Post interventions and up to 3 months after the interventions
measure: Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV
timeFrame: Post interventions and up to 3 months after the intervention
measure: Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine
timeFrame: post intervention and up to 3 months after the interventions
measure: 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
timeFrame: post interventions and up to 3 months after the intervention
measure: 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
timeFrame: Post interventions and up to three months after the intervention
measure: Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine
timeFrame: Post interventions and up to 3 months follow-up
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Manoj Sharma
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Manoj Sharma, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Rebecca Lee, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Cincinnati
name: Purvi Mehta, MS
role: STUDY_DIRECTOR
References: