Study of the Prevention of Anal Cancer

NACompletedINTERVENTIONAL
Enrollment

617

Participants

Timeline

Start Date

September 10, 2010

Primary Completion Date

May 4, 2018

Study Completion Date

December 4, 2018

Conditions
Human PapillomavirusCancer
Interventions
PROCEDURE

Participants asked questions about recent experiences of anal intercourse in the last six months.

"Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months.~At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews."

PROCEDURE

High Resolution Anoscopy

The HRA is performed on HIV positive and HIV negative participants by study doctor after an examination of the perianal region and perineum. The plastic anoscope is inserted into the anal canal and visualised under high resolution magnification. Biopsy samples will be taken by the clinician for histological assessment if there are any detected abnormalities.

Trial Locations (2)

2010

Applied Medical Research (AMR CRP), St. Vincent's Hospital, Sydney

2050

RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown, Sydney

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kirby Institute

OTHER_GOV