Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01422356
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2011-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men
Sponsor:
The Alfred
Organization:
Study Overview
Official Title:
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPER
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: