Phase 4
N=90
A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men
HPV Vaccine Acceptability
Bottom Line
View on ClinicalTrials.gov: NCT01431079 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: 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 — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HPV vaccine acceptability (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Cincinnati
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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) |
2.16; 2.28; 2.78; 2.27; 2.70; 1.67 | — |
| SECONDARY Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV |
3.69; 3.51; 5.84; 3.67; 4.80; 5.67 | — |
| SECONDARY Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV |
9.22; 9.06; 10.44; 9.11; 11.10; 8.83 | — |
| SECONDARY Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine |
5.76; 7.08; 9.04; 7.40; 7.90; 5.67 | — |
| SECONDARY 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 |
6.58; 5.35; 3.53; 5.49; 4.30; 6.50 | — |
| SECONDARY 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 |
3.44; 4.35; 5.07; 4.27; 6.50; 6.67 | — |
| SECONDARY Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine |
6.60; 6.80; 8.49; 6.93; 8.80; 6.00 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01431079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.