HPV Vaccine Acceptability Among Young Men Who Have Sex With Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01535794
Recruitment Status : Completed
First Posted : February 20, 2012
Last Update Posted : August 8, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Indiana University

Brief Summary:

The FDA has recently approved Gardasil for the prevention of anal cancer in people aged 9-26. Men who have sex with men (MSM) have disproportionately high rates of anal cancer and could benefit greatly from vaccination. Vaccine uptake among young MSM (YMSM) is poor, and little is known about factors associated with vaccine acceptance in this population. With the risk of anal cancer among MSM higher than the risk of cervical cancer among women before routine cytological screening was introduced, acceptance of a prophylactic vaccine in this subgroup is the most cost-effective and attainable strategy to greatly reduce the prevalence of anal cancer. While the investigators can assume the human papillomavirus (HPV) vaccine has many acceptable concepts among these men, there are multiple barriers which may potentially interfere with their likelihood of initiating the vaccine series. Vaccine catch-up rates among women of a similar age has been poor, and there is no reason to expect this to be higher among men. One potential strategy to increase vaccine uptake in this catch-up group is to implement a patient-driven program to promote vaccination among men.

This project will contribute to the investigators understanding of how the investigators can utilize social networks to identify barriers to HPV vaccination among YMSM, and how to potentially influence a patient-driven vaccination effort to increase uptake among men in the catch-up age group. This research will inform future interventions to targeted populations that may be incorporated into online social networking websites to encourage HPV vaccination.

Condition or disease
HPV Vaccine Attitudes HPV Vaccine Intention

Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exploring the Potential for Social Network Site-delivered Interventions to Increase HPV Vaccine Uptake Among Men Who Have Sex With Men
Study Start Date : February 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

18-26 year old men who have sex with men

Primary Outcome Measures :
  1. HPV vaccine acceptability [ Time Frame: Spring 2012 ]
    The primary outcome in this study is young men's intention to be vaccinated for human papillomavirus (HPV). This will be measured on a scale of 0-100, with a higher number indicating greater likelihood of future vaccination. No vaccine will be administered.

Secondary Outcome Measures :
  1. Attitudes towards HPV vaccination [ Time Frame: Spring 2012 ]
    A secondary outcome will be young men's attitudes towards HPV vaccination, including their beliefs about vaccine safety, efficacy, and effectiveness. This outcome will also assess the presence of logistical or pragmatic barriers to their future vaccination.

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be an internet-based, cross-sectional study targeting all US profiles of two separate online social/sexual networking communities of YMSM. A recruitment email will be sent internally to all active US profiles for men 18-26 years old.

Inclusion Criteria:

  • 18-26 years old
  • male

Exclusion Criteria:

  • younger than 18 years old
  • older than 26 years old
  • female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01535794

United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Merck Sharp & Dohme Corp.

Responsible Party: Indiana University Identifier: NCT01535794     History of Changes
Other Study ID Numbers: YMSM HPV vaccine acceptability
First Posted: February 20, 2012    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

Keywords provided by Indiana University:
HPV vaccine
men who have sex with men

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs