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

NCT ID: NCT01431079

Last Updated: 2013-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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HPV Vaccine Acceptability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HPV vaccine acceptability

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

HPV vaccine acceptability

Intervention Type BEHAVIORAL

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

Interventions

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HPV vaccine acceptability

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Sharma Manoj

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manoj Sharma, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Rebecca Lee, Ph.D.

Role: STUDY_DIRECTOR

University of Cincinnati

Purvi Mehta, MS

Role: STUDY_DIRECTOR

University of Cincinnati

Locations

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Manoj Sharma

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://www.merck.com

Manufactures HPV vaccine

Other Identifiers

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39991

Identifier Type: OTHER

Identifier Source: secondary_id

11083108

Identifier Type: -

Identifier Source: org_study_id

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