Questions and Answers

This study will be conducted over three years, with four scheduled annual visits (including this one) and three six-monthly visits between the annual visits.

If you agree to participate in this trial, you will then be asked to undergo the following procedures:

1. A computer assisted interview that will ask questions on a wide range of topics including sexual relationships and practices, drug use and general health. This will take 30 to 40 minutes to complete;
   
2. Blood tests. Samples of blood from a vein will be taken by a trained nurse. The total amount of blood taken will be 20 to 25 ml (about one tablespoon). It will be tested for syphilis. If you consent, blood will be taken to be stored for additional testing at a later date. HIV negative participants and participants who have not had an HIV test at St Vincent's Hospital or RPA Sexual Health, will also be tested for HIV. HIV-negative participants will undergo pre-test counselling before each scheduled HIV test. Should you test HIV-positive at screening or during the study, the study nurse or physician will organise post-test HIV counselling. You would be able to stay in the study.
   
   
3. Two anal swabs. A research clinician or nurse will collect two separate anal swabs from you. This involves the insertion of each swab into your anus, which will be then be rotated against the anal canal wall. The first swab will be used to test the cells from your anus for anal HPV using "PCR", a molecular test. The cells from the swab will also be assessed to see if they are abnormal in any way ("cytology"), including the presence of SIL. The second swab will be used to test for anal gonorrhoea and chlamydia.
   
   
4. A urine sample and a throat swab. You will be asked to collect a urine sample and a nurse will collect a throat swab. These will be used to test for gonorrhoea and chlamydia.
   
   
5. A high resolution anoscopy (HRA). You will also be scheduled to undergo an HRA at St. Vincent's Hospital or RPA Sexual Health, depending on which clinic you attend. The doctor will first perform a digital rectal examination by inserting his/her index finger into your anus to detect any irregularities. The doctor will then apply lubricant mixed with local anaesthetic before inserting a small plastic tube into your anal canal. This special technique will allow the doctor to view the anal canal under magnification. A gauze swab soaked in a chemical (acetic acid) will be placed in the anal canal and removed after a minute. This will help identify any abnormal areas. If there are any significant visible abnormalities, the doctor may take a small sample of tissue using special tweezers and have the tissue analysed by a pathologist ("histology"). Photographs of abnormalities detected in the anal region may be taken for documentation purposes and to follow any abnormalities in the anal canal.
   
   
6. Two brief (around ten minutes) questionnaires to assess your psychological well-being in relation to any diagnoses of anal disease you receive in the study, one two weeks after your visit.
   
   
7. At a 6th visit, at least 2 months after your 5th SPANC visit, a study doctor will discuss with you all your SPANC study results. No procedures will be performed at this visit.

Some of these procedures will be repeated at follow up annual visits and the six-monthly visit. You can expect that the computer-assisted interviews at follow up visits to be brief, taking about 30 minutes to complete. The questions will mostly concern recent potential sexual exposures to anal HPV. Blood collection will only occur at annual visits. After the baseline visit, all participants will undergo HRA again at the second and final visits. You may require extra HRA examinations if you are found to have a significant abnormality on anal cell examination or on the anal biopsy.

Participating in the study will require some restrictions on your lifestyle during the study. You will be advised to refrain from having receptive anal intercourse or inserting objects into your anus for at least 7 days after HRA.

The study is being funded by the National Health and Medical Research Council of Australia and Cancer Council New South Wales. 

• You may experience some mild discomfort and minor bruising or swelling at the site where blood is collected.
  
  
• In some participants, taking anal swabs can cause minor bleeding immediately after the procedure, especially in men with pre-existing lesions of the anal canal, such as anal warts. The study doctor or research nurse will manage any bleeding before you leave. Minor bleeding is expected to occur in <5% of men in this study. It is possible that you will notice a small amount of blood in your first bowel motion following the procedure, but this should not persist. If it does, please contact the SPANC research nurse.
  
  
• The HRA examination may be uncomfortable, but is not painful, due to the local anaesthesia. It takes around 20 minutes to complete the procedure. Slight anal bleeding may occur for 24-48 hours after the procedure. Occasionally there is further, slight bleeding 4-5 days later and having a bowel motion may trigger slight bleeding. There is a very small risk of a large amount of bleeding after the procedure. The procedure itself, and awaiting the pathology result, may cause anxiety in some men. You should not have receptive anal intercourse, or insert anything into your anus for at least 7 days after undergoing this procedure.
  
  
• Although it is a generally safe procedure, in a minority of participants taking an anal swab can cause slight tearing and bleeding in the anus. During the seven days after the procedure, it is possible that this may increase the risk of HIV infection should you have unprotected receptive anal intercourse.

If you suffer any injuries or complications as a result of this study, you should contact the study nurse as soon as possible, who will assist you in arranging appropriate medical treatment.

You may have a right to take legal action to obtain compensation for any injuries or complications resulting from the study. Compensation may be available if your injury or complication is caused by the procedures, or by the negligence of any of the parties involved in the study. If you receive compensation that includes an amount for medical expenses, you will be required to pay for your medical treatment from those compensation monies.

If you are not eligible for compensation for your injury or complication under the law, but are eligible for Medicare, then you can receive any medical treatment required for your injury or complication free of charge as a public patient in any Australian public hospital.

Important clinical findings, including your anal cytological and histological results (i.e. tests looking at the cells in the anal canal), will be made available to you . The results of anal HPV tests (looking for the presence of the HPV virus in the anal canal), however, will not be made available to you until your final visit (visit #6) because they are not routinely used for diagnostic purposes. These tests are ultra sensitive, and testing positive does not necessarily mean an infection. At your final visit (visit #6), all the critical anal screening results, including cytological, histological and your HPV test results, will be summarised and explained to you in detail by the study doctor. Although this may not provide you with any direct benefit, the information gained from this study will be used to guide an anal cancer screening program in homosexual men at high risk. 

Should you wish to know further about these results, an appointment can be made with the study physician to explain what the results mean for you and to refer you for further support and management if necessary.

It is possible that we may diagnose and treat anal abnormalities in you, but we cannot and do not guarantee or promise that you will receive any benefits from this Study.

Currently, there are no evidence based guidelines as to how high grade (more severe) anal abnormalities should be treated, and a substantial proportion of the high-grade lesions will resolve without treatment ("disease regression"). All participants with high-grade lesions will be closely monitored, and only those with significant anal abnormalities will be referred for further treatment at the discretion of the study physician who has extensive experience with managing such conditions.

Participation in this study will not cost you anything. You will receive no payment for participating in the study. However, the cost for taking public transport to attend scheduled visits will be reimbursed for up to $25 each visit. You will be given a voucher of $10 worth to redeem at the cafe at the St Vincent’s Hospital or RPA Hospital.

If you do agree to your tissue samples being stored, they will not be used for other research projects, except with your written consent or, under some circumstances, with the approval of a Human Research Ethics Committee at that time.

[See NSW Health Standard Patient Information Sheet for 'tissue banking']