Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men (HYPER)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Christopher Fairley, The Alfred
ClinicalTrials.gov Identifier:
NCT01422356
First received: August 16, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

Studies indicate that men who have sex with men (MSM) have a high prevalence of anogenital Human papillomavirus (HPV) infection and increased risk for HPV related anogenital lesions including anogenital warts, anal intraepithelial neoplasia (the abnormal proliferation of cells) and anal cancer. Currently in Australia, HPV vaccine for men is not covered by programs. This study will explore the prevalence of HPV infection and sexual behaviours associated with varying prevalence of HPV infection.

The investigators will survey 200 MSM aged 16-20 years who just started their sexual life. The investigators will use a questionnaire to collect information of socio-demographic characteristics, lifetime sexual experience, recent sexual experience, the most recent sexual contact, sexually transmitted infections (STIs)/HIV history and testing history, HPV knowledge and attitude, smoking/alcohol/drug/circumcision. The investigators will also collect oral, penile and anal samples as well as blood samples to test for HPV DNA and antibody.

The study will include four visits in the 12-month period. In each visit, participants will be asked to fill a questionnaire and provide oral, penile and anal samples as well as blood samples.


Condition
Human Papillomavirus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • HPV Prevalence [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Prevalence of anal HPV of any type at baseline


Biospecimen Retention:   Samples With DNA

Genital samples (genital swabs from anus, penis), oral rinse, and serum.


Enrollment: 200
Study Start Date: September 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Study aims

The objectives of this study are to determine among younger MSM:

  1. The prevalence of HPV infection
  2. Sexual behaviours associated with varying prevalence of HPV infection

Methods

Criteria for eligibility:

  • Men aged 16 to 20
  • Same sex attracted
  • Able to complete all study requirements including questionnaire in English and completion of 4 visits

Recruitment

Men were recruited between October 2010 and September 2012 via a number of avenues focusing on gay teenage males: community organizations supporting gay teenagers with study promotion at social events such as dance parties; gay clubs at six Melbourne universities; gay community events including the MidSumma Festival; gay media including radio and magazine; the study website; and social networking websites including Facebook, Twitter and Grindr. Recruitment also took place through three sexual health services in Melbourne.

Men were assessed by the study nurse at a baseline visit then 3, 6, and 12 months later. On each occasion specimens were obtained for HPV DNA testing, blood was obtained for HPV serology, and men completed a questionnaire regarding their sexual experiences.

Specimen collection Specimens were obtained from men for HPV DNA testing in the following order: first an oral rinse, second an anal canal swab, third a perianal swab, then fourth a penile swab. The oral rinse and penile swab were self-collected by men after watching a video demonstrating how to self-collect these specimens

Men were screened for pharyngeal and rectal Neisseria gonorrhoeae using modified Thayer-martin media. First void urine and a rectal swab were tested for Chlamydia trachomatis by strand displacement assay (Becton Dickinson ProbeTec ET, NJ, USA). In addition, men were screened for syphilis using enzyme immunoassay (EIA) and rapid plasma reagin and tested for HIV using EIA.

  Eligibility

Ages Eligible for Study:   16 Years to 20 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Young same sex attracted men 16-20 years of age from Melbourne

Criteria

Inclusion Criteria:

  • Men aged 16 to 20
  • Same sex attracted
  • Able to complete all study requirements including questionnaire in English and completion of 4 visits
  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: NCT01422356

Locations
Australia, Victoria
Alfred Health (Melbourne Sexual Health Centre)
Melbourne, Victoria, Australia, 3053
Sponsors and Collaborators
The Alfred
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Christopher K Fairley, MB BS, Ph D Alfred Health
  More Information

No publications provided

Responsible Party: Christopher Fairley, Professor of Public Health Central Clinical School Monash University and Director Melbourne Sexual Health Centre Alfred Health, The Alfred
ClinicalTrials.gov Identifier: NCT01422356     History of Changes
Other Study ID Numbers: MSHC-174/10
Study First Received: August 16, 2011
Results First Received: October 27, 2013
Last Updated: December 19, 2013
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by The Alfred:
cohort study
men who have sex with men

ClinicalTrials.gov processed this record on October 30, 2014