N/A
N=200
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men
Human Papillomavirus
Bottom Line
View on ClinicalTrials.gov: NCT01422356 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: HPV Prevalence — 61 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Male
- Sponsor
- The Alfred
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HPV Prevalence |
61 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01422356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.