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

NCT01431079 | Completed Phase 4 Results

• 2 other identifiers: 1108310839991
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV Vaccine Acceptability

Keywords

HPV; College men; HPV vaccine; Health belief model; HPV vaccine acceptance

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Post intervention and up to 3 months after the interventions

• 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)

  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.

  Post intervention and up to 3 months after the intervention

Secondary Outcomes (6)

• Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV

  Post interventions and up to 3 months after the interventions

• Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV

  Post interventions and up to 3 months after the intervention

• Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine

  post intervention and up to 3 months after the interventions

• 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

  post interventions and up to 3 months after the intervention

• 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

  Post interventions and up to three months after the intervention

Study Arms (2)

Health belief model based education

EXPERIMENTAL

This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.

Behavioral: HPV vaccine acceptability

Knowledge-based education

ACTIVE COMPARATOR

This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.

Behavioral: HPV vaccine acceptability

Interventions

HPV vaccine acceptability BEHAVIORAL

One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.

Health belief model based education; Knowledge-based education

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Females
• Under 18 years, or above 25 years
• Non- English speaking individuals
• Non-university attending students
• If already received HPV vaccination

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Manoj Sharma

Cincinnati, Ohio, 45221-0068, United States

Location

Related Links

• Manufactures HPV vaccine

Limitations and Caveats

Overall limitation of the trial were due to attrition at the one month follow up. This was due to the end of school year.This meant that students were busy preparing for finals, starting co-ops/internships, moving back home, or lack of interest.

Results Point of Contact

• Title: Dr. Manoj Sharma, PI
• Organization: University of Cincinnati

manoj.sharma@uc.edu

513-556-3878

Study Officials

• Manoj Sharma, Ph.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Rebecca Lee, Ph.D.

  University of Cincinnati

  STUDY DIRECTOR

• Purvi Mehta, MS

  University of Cincinnati

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 4, 2013
• Results First Posted: December 10, 2012

Record last verified: 2013-01

Locations

US (1)