The goal of this study is to see whether treating anal high-grade squamous intraepithelial lesions (HSIL) is useful in preventing anal cancer compared with watching HSIL carefully without treatment (active monitoring). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer. It is not yet known if treating HSIL is more effective than active monitoring in preventing patients from developing anal cancer. The study will help determine the best way to prevent anal cancer among HIV positive men and women.
The lesions that can cause anal cancer (high-grade squamous intraepithelial lesions or HSIL for short) are found in at least half of HIV infected men and 20% of HIV infected women. These lesions have no symptoms. We know that for women, treating HSIL on the cervix can prevent cancer, so we’re hopeful that treating these lesions in the anus will also prevent cancer. But this hasn’t been proven yet and therefore most doctors in the United States don’t screen for it or treat it. Eligibility for participation will be determined during a screening visit which will include high resolution anoscopy and biopsies for anal HSIL.
Eligible participants who are found to have HSIL and consent to participate will be randomized to one of two groups: Active Monitoring or Treatment. Treatment will consist of one or a combination of five approaches to ablating HSIL which will be chosen by the treating physician in consultation with the patient:
The researchers involved with the design of this protocol estimate that the risk of developing anal cancer even if HSIL is not being treated is about 1 in 40 over a 5-year follow-up period. If anal cancer is found at any time during the study, participation in the study will end, and the patient will be immediately referred for the necessary treatment. If the participant develops cancer during the study, since they will be watched frequently there is a chance that the cancer may be caught earlier than if you were not in the study and not being followed at all. Cancers caught earlier tend to respond better to treatment, and may possibly be treated with a simple local removal in the operating room instead of chemotherapy and radiation therapy.