NCT00799474

Brief Summary

This research focuses on men who have sex with men (MSM) who are at higher risk of anal cancer. The survey will evaluate their beliefs about anal and oral cancer, their knowledge about role of human papillomavirus (HPV) infection in these cancers, and their knowledge of HPV vaccination and anal Pap smears. Approximately 12% of subjects will be HIV-positive.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
609

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 15, 2010

Completed
Last Updated

March 24, 2016

Status Verified

January 1, 2010

Enrollment Period

1 month

First QC Date

November 26, 2008

Results QC Date

December 7, 2009

Last Update Submit

February 25, 2016

Conditions

Anus Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Willingness to Receive the Human Papillomavirus (HPV) Vaccine

    Measured participants' willingness to receive HPV vaccine. Participants were asked how willing they would be to get HPV vaccine if it were approved for use in males. A 5-point scale ranging from "definitely not willing" to "definitely willing" was used to meausure willingness.

    at time of interview

Secondary Outcomes (2)

  • Awareness of HPV Vaccine

    At time of interview

  • Knowledge of HPV

    At time of interview

Eligibility Criteria

Age18 Years - 59 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Approximately 600 men (ages 18-59) who have agreed to participate in a periodic panel through the private survey company, Knowledge Networks.

You may qualify if:

  • male
  • aged 18-59
  • answered question about sexual orientation

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Results Point of Contact

Title
Dr. Noel Brewer, PhD
Organization
The University of North Carolina at Chapel Hill, Gillings School of Global Public Health
ntb1@unc.edu
919-966-3282

Study Officials

  • Noel Brewer, PhD

    The University of North Carolina at Chapel Hill, School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 24, 2016

Results First Posted

January 15, 2010

Record last verified: 2010-01