None listed
Conditions
Brief summary
This is a study of anal (HPV) infection and related anal disease in gay men. Both HIV positive and HIV negative men are eligible. You should not have been previously diagnosed with anal cancer. All participants in this study will undergo high resolution anoscopy during the study over 36 months. The first HRA will be conducted at Baseline and at all 4 follow up visits. The high resolution anoscopy involves, examination of the peri-anal region and perineum, and the a plastic anoscope is inserted into the anal canal. Following staining of the anal canal with acetic acid and lugol's solution, the anal canal is visualised under high resolution magnification. Biopsy samples will be taken by the clinician for histological assessment if there are any detected abnormalities. The data collected from these examinations will be used to determine the prevalence, incidence and risk factors for specific types of human papillomavirus (HPV) infection. There are more than 100 type of HPV. Some cause genital warts and other types cause more than 90% of anal cancer. Gay men are over 20 times more likely than others to develop anal cancer. The information collected in this study may guide the possible future introduction of anal cancer screening programs for gay men.
Interventions
High Resolution Anoscopy (HRA) is being used to determine if the study will provide important information to guide the possible future introduction of anal cancer screening program for gay men. The HRA examination takes about 20 minutes for perform. It is not generally painful, due to local anaesthesia given prior to the procedure. Mild, transient anal bleeding may occur, for 72 hours after the procedure. The HRA procedure is conducted at Baseline and all 4 follow up visits which occur 6 mo
High Resolution Anoscopy (HRA) is being used to determine if the study will provide important information to guide the possible future introduction of anal cancer screening program for gay men. The HRA examination takes about 20 minutes for perform. It is not generally painful, due to local anaesthesia given prior to the procedure. Mild, transient anal bleeding may occur, for 72 hours after the procedure. The HRA procedure is conducted at Baseline and all 4 follow up visits which occur 6 months after Baseline and then annually to 36 months. There is a very small risk of a significant post-procedure haemorrhage. During the seven days after the procedure, it is possible that this may increase the risk of HIV infection should the participant have unprotected receptive anal intercourse. The procedure itself, and awaiting the pathology result, may cause anxiety in some participants. After having this procedure the participants are advised not to have receptive anal intercourse for at least 7 days. As a result of this procedure some participants may be referred for treatment of anal abnormalities.
Sponsors
University of New South Wales, Sydney Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria are: male homosexual aged 35 years or above; HIV positive participants: documented to be HIV positive; HIV negative participants: tested HIV negative at recruitment; provision of informed, written consent.
Exclusion criteria
The exclusion criteria are: participants unable to attend scheduled follow-up interviews or unwilling to undergo high resolution anoscopies (HRA); unable to understand English; having bleeding disorders or currently taking anti-coagulant medications; having previously received HRA; having ever been diagnosed with anal cancer.
Outcome results
None listed