NCT01422356

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 10, 2014

Completed
Last Updated

February 10, 2014

Status Verified

December 1, 2013

Enrollment Period

3 years

First QC Date

August 16, 2011

Results QC Date

October 27, 2013

Last Update Submit

December 19, 2013

Conditions

Human Papillomavirus

Keywords

cohort studymen who have sex with men

Outcome Measures

Primary Outcomes (1)

  • HPV Prevalence

    Prevalence of anal HPV of any type at baseline

    Baseline

Eligibility Criteria

Age16 Years - 20 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Health (Melbourne Sexual Health Centre)

Melbourne, Victoria, 3053, Australia

Location

Related Publications (3)

  • Chow EPF, Fairley CK, Zou H, Wigan R, Garland SM, Cornall AM, Atchison S, Tabrizi SN, Chen MY. Human Papillomavirus Antibody Levels Following Vaccination or Natural Infection Among Young Men Who Have Sex With Men. Clin Infect Dis. 2022 Aug 25;75(2):323-329. doi: 10.1093/cid/ciab1052.

    PMID: 34971362DERIVED

  • Chow EPF, Tabrizi SN, Fairley CK, Wigan R, Machalek DA, Garland SM, Cornall AM, Atchison S, Hocking JS, Bradshaw CS, Balgovind P, Murray GL, Chen MY. Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study. Lancet Infect Dis. 2021 Oct;21(10):1448-1457. doi: 10.1016/S1473-3099(20)30687-3. Epub 2021 May 24.

    PMID: 34043963DERIVED

  • Zou H, Tabrizi SN, Grulich AE, Hocking JS, Bradshaw CS, Cornall AM, Morrow A, Prestage G, Law MG, Garland SM, Chen MY, Fairley CK. Site-specific human papillomavirus infection in adolescent men who have sex with men (HYPER): an observational cohort study. Lancet Infect Dis. 2015 Jan;15(1):65-73. doi: 10.1016/S1473-3099(14)70994-6. Epub 2014 Nov 28.

    PMID: 25435055DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Limitations and Caveats

The findings from this study may or may not extend to other populations of teenage MSM.

Results Point of Contact

Title
Associate Professor Marcus Chen
Organization
Melbourne Sexual Health Centre, Alfred Health
mchen@mshc.org.au
+61 3 9341 6260

Study Officials

  • Christopher K Fairley, MB BS, Ph D

    The Alfred

    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
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Public Health Central Clinical School Monash University and Director Melbourne Sexual Health Centre Alfred Health

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 24, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 10, 2014

Results First Posted

February 10, 2014

Record last verified: 2013-12

Locations

AU(1)