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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01422356
Acronym
HYPER
Enrollment
200
Registered
2011-08-24
Start date
2010-09-30
Completion date
2013-09-30
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus

Keywords

cohort study, men who have sex with men

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.

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.

Interventions

None listed

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
The Alfred
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
16 Years to 20 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
HPV PrevalenceBaselinePrevalence of anal HPV of any type at baseline

Countries

Australia

Participant flow

Recruitment details

Two hundred males aged 16 to 20 years were recruited into the study. Men were seen at 0, 3, 6 and 12 months.

Participants by arm

ArmCount
12 Month Cohort200
Total200

Baseline characteristics

Characteristic12 Month Cohort
Age, Continuous19 years
Region of Enrollment
Australia
200 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
200 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 200
serious
Total, serious adverse events
0 / 200

Outcome results

Primary

HPV Prevalence

Prevalence of anal HPV of any type at baseline

Time frame: Baseline

Population: Number of men at baseline visit

ArmMeasureValue (NUMBER)
Baseline PrevalenceHPV Prevalence61 participants

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026