Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men (HYPER)
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 persistent HPV infection, distinguishing this from transient 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, mRNA 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men|
- HPV infection [ Time Frame: For one year from T=0 to T=12 months ] [ Designated as safety issue: No ]
- Persistent HPV infection versus deposition Persistent HPV infection: detection of HPV DNA on at least 2 consecutive occasions at least 6 months apart (for times between T=0 and T=12); HPV deposition: detection of HPV DNA on one occasion only
- mRNA testing mRNA for HPV detection between T=0 and T=12 months
- HPV serology Positive serology for HPV between T=0 and T=12 months.
Biospecimen Retention: Samples With DNA
Genital samples (genital swabs from anus, penis), oral rinse, and serum.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Alfred Health (Melbourne Sexual Health Centre)||Recruiting|
|Melbourne, Victoria, Australia, 3053|
|Contact: Christopher Fairley, Ph D 61 3 9341 6241 email@example.com|
|Contact: Marcus Chen, Ph D 61 3 9341 6260 firstname.lastname@example.org|
|Principal Investigator: Christopher Fairley, MB BS, Ph D|
|Principal Investigator:||Christopher K Fairley, MB BS, Ph D||Alfred Health|