The HPV-SAVE study has two sections: A-Screening and B-Treatment. 

HPV-SAVE Section A: Screening

1-hour Screening visit:

• Explanation of study and assessment of eligibility
• Informed consent
• Demographic questionnaire
• Medical history
• Anal swab for Pap and HPV testing
  
  You may have one of the following results: normal (no abnormal changes in the cells), unsatisfactory or inadequate (specimen collected was not adequate), atypical (cells are abnormal but there is no definite diagnosis), low-grade (mild dysplasia), atypical cells that cannot exclude a high-grade lesion and high-grade (moderate to severe dysplasia).
  
  If you are found to have high-grade dysplasia detected by your Pap smear, you will be offered High Resolution Anoscopy and biopsy to confirm diagnosis. If you receive another result that is not high-grade dysplasia you may also be randomly selected and offered High Resolution Anoscopy and biopsy to confirm diagnosis. 

1 hour High Resolution Anoscopy visit (If eligible from screening and baseline visits):

• Informed consent and questionnaire
• Anal swab for Pap testing
• Sexually Transmitted Infection testing
• Digital rectal exam
• High resolution anoscopy with biopsies
  
  High Resolution Anoscopy is a procedure where magnification is used to visualize the anal mucosa through a plastic anoscope. High Resolution Anoscopy is performed in the clinical setting and no bowel preparation is necessary before the procedure. During the anoscopy procedure, you will be asked to undress from your pants down and to lie on your side with your knees drawn to your chest. An anoscope is a small hollow plastic tube which is inserted a few centimeters into the anal canal to inspect for abnormal cells. The anoscope is inserted with lubricant and a numbing gel. Next, a cotton swab that is soaked with acetic acid (vinegar) is inserted through the hollow anoscope and into the anus. The anoscope is removed and the cotton swab is left in the anus for one minute. The vinegar assists in turning any abnormal cells white. After one minute, the cotton swab is removed and the anoscope is reinserted with lubricant and the numbing gel. The interior of the anus is examined with a high-resolution colposcope. Iodine is applied inside the anus. Iodine staining versus non-staining identifies precancerous changes.
  
  A biopsy involves taking a small bit of tissue from the anal canal in order to make a definite diagnosis. The tissue is examined in the pathology lab to determine if the tissue is abnormal. The biopsy is usually not painful but you will feel some tugging and brief discomfort. Sedation during anoscopy and anal biopsy is not typically given. However, some bleeding is normal when you move your bowels in the next day or two. The actual High Resolution Anoscopy procedure only takes 15 minutes to complete. Excessive bleeding or infections are rare. We will give you a form that includes after-procedure instructions. 

HPV-SAVE Section B: Treatment

If results from the high resolution anoscopy and biopsies confirm pre-cancer changes, you will be offered entry into the treatment phase of the study. There is little understanding as to if treatment has a beneficial outcome, and as such you will be randomly assigned to one of two study arms:

1. Treatment arm: where you will receive treatment of the abnormal area and regular monitoring, or
2. Surveillance arm: where you will not receive treatment but will be followed with regular monitoring.

Visits will occur every 6 months for 3 years and you can expect the visit to include:

• Informed consent and questionnaire
• Anal swabs for Pap testing
• High resolution anoscopy with biopsies