HPV Vaccine Acceptability Among Young Men Who Have Sex With Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Indiana University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01535794
First received: February 13, 2012
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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
HPV Vaccine Attitudes
HPV Vaccine Intention

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • HPV vaccine acceptability [ Designated as safety issue: No ]
    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:
  • Attitudes towards HPV vaccination [ Designated as safety issue: No ]
    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 pragamatic barriers to their future vaccination.


Estimated Enrollment: 2000
Study Start Date: February 2012
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
18-26 year old men who have sex with men

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Male
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.

Criteria

Inclusion Criteria:

  • 18-26 years old
  • male

Exclusion Criteria:

  • younger than 18 years old
  • older than 26 years old
  • female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535794

Contacts
Contact: Nathan W Stupiansky, PhD 317-278-0672 nstupian@indiana.edu

Locations
United States, Indiana
Indiana University School of Medicine Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Nathan W Stupiansky, PhD    317-278-0672    nstupian@indiana.edu   
Principal Investigator: Nathan W Stupiansky, PhD         
Sponsors and Collaborators
Indiana University
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01535794     History of Changes
Other Study ID Numbers: YMSM HPV vaccine acceptability
Study First Received: February 13, 2012
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014