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

Human Papillomavirus Clinical Trial

— HYPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422356
• Other study ID #: MSHC-174/10
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: December 19, 2013
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 20 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus

Locations

Country	Name	City	State
Australia	Alfred Health (Melbourne Sexual Health Centre)	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
The Alfred	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV Prevalence	Prevalence of anal HPV of any type at baseline	Baseline	No