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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
History of Changes
Results First Received: September 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: HPV Vaccine Acceptability
Intervention: Behavioral: HPV vaccine acceptability

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Recruitment for Phase I of the study was conducted between Oct. 2011-Nov. 2011 at the University of Cincinnati. Snowball sampling was done (n=50).

Phase II occurred between March 2012-April 2012 at the University. A snowball sample was used. 90 participants were recruited. A post test was done immediately after the intervention.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable.

Reporting Groups
  Description
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.

HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
Knowledge-based Education

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

HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.

Participant Flow:   Overall Study
    Health Belief Model Based Education     Knowledge-based Education  
STARTED     45     45  
Post-test     45     45  
COMPLETED     10     6  
NOT COMPLETED     35     39  
Lost to Follow-up                 35                 39  



  Baseline Characteristics
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Reporting Groups
  Description
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.

HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
Knowledge-based Education

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

HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
Total Total of all reporting groups

Baseline Measures
    Health Belief Model Based Education     Knowledge-based Education     Total  
Number of Participants  
[units: participants]
 		  45     45     90  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     45     45     90  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  19.76  ± 1.04     20.6  ± 2.44     20.2  ± 1.14  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     45     45     90  
Region of Enrollment  
[units: participants]
 		     
United States     45     45     90  



  Outcome Measures
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1.  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   [ Time Frame: Post intervention and up to 3 months after the interventions ]
  Show Outcome Measure 1

2.  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)   [ Time Frame: Post intervention and up to 3 months after the intervention ]
  Show Outcome Measure 2

3.  Secondary:   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 ]
  Show Outcome Measure 3

4.  Secondary:   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 ]
  Show Outcome Measure 4

5.  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   [ Time Frame: post intervention and up to 3 months after the interventions ]
  Show Outcome Measure 5

6.  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   [ Time Frame: post interventions and up to 3 months after the intervention ]
  Show Outcome Measure 6

7.  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   [ Time Frame: Post interventions and up to three months after the intervention ]
  Show Outcome Measure 7

8.  Secondary:   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 ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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:  
Name/Title: Dr. Manoj Sharma, PI
Organization: University of Cincinnati
phone: 513-556-3878
e-mail: manoj.sharma@uc.edu


No publications provided


Responsible Party: Sharma Manoj, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01431079     History of Changes
Other Study ID Numbers: 11083108, 39991
Study First Received: September 3, 2011
Results First Received: September 30, 2012
Last Updated: January 30, 2013
Health Authority: United States: University of Cincinnati
United States: Merck Pharmaceuticals
United States: Institutional Review Board