What Risks are Involved?

Will I be at a heightened risk for cancer during the study?

It isn’t expected that any treatment you receive in this study will heighten your risk for cancer. You will be closely monitored for anal cancer for the entire duration of the study. If you start to show pre-cancerous or cancerous changes, we will immediately refer you to another doctor for appropriate treatment.

How long will I be in the study?

The researchers plan to recruit volunteers for the study over a period of three years or more. We will follow all participants for at least five years after the last participant starts the study. Participants who start the study in the first year may be in the study for up to eight years or more. You will be assigned to one study arm (treatment or active monitoring) for the entire study. Initially (for the first few months) you may need to come in every few weeks, but after that you will come in every 6 months for the remainder of the 5-8 years. In total, you can expect 12-18 study visits, including the screening visit, and each visit lasts approximately 2 hours. Total time commitment will be between 25-36 hours over the course of 5-8 years.

Will I be paid?

Eligible participants who enroll in our study are paid $100 per study visit to compensate for time, effort, and travel expenses. If you attend every scheduled visit, the amount of money we pay you will total between $1200-$2100, depending on which group you are randomly assigned to and which treatment type you receive if you’re assigned to the treatment group.

Will I experience any pain while in the study?

Most people find the screening of anal lesions to be somewhat uncomfortable. It’s also possible that you will experience some discomfort in the days following your exam. Your doctor will advise you on self-care that may alleviate discomfort. For both screening and treatment of anal lesions, we will numb the local area to minimize discomfort.

What will be expected of me during the study?

Participants are expected to do the best they can to make it to scheduled appointments. Our study staff will give you courtesy reminders prior to all of your study visits. If an emergency comes up and you can’t make it to your appointment, we ask that you give us a heads up so we can reschedule you as soon as possible. Depending on the type of treatment you are receiving, you may need to complete some treatment or monitoring at home. As a study participant you are expected to follow all of your clinician’s directions, and let us know if you’re having any trouble with what you are being asked to do. We also expect you to ask lots of questions! We want you to clearly understand what we are doing and why, and we’re here to provide the best care possible.

Can I have sex while in the study?

Yes! You may undergo some procedures that will require you to abstain from receptive anal intercourse for several weeks, but after that you should be good to go!

Is this study ethical?

The design of this study is the only way to definitively test whether treatment of anal HSIL can help prevent anal cancer. Participants in the active monitoring group may be at risk of progressing to anal cancer. However, we don’t know whether treating HSIL will prevent cancer, and individuals in the treatment group may be at similar risk. If treatment of HSIL is shown to be ineffective at reducing cancer risk, participants in the observation group will be spared the discomfort and potential risks of treating HSIL.

Can I back out of the study at any time?

Participants in any research study have the right to leave at any time without fear of retaliation or damaging relationships. We will do our best to make sure you have a positive experience in the study. This includes providing you with proper expectations of what we will ask you to do. In between study visits, we will check in with you by emailing a questionnaire where you can tell us about any difficulties you experience in the study. We will work closely with you to address your concerns because our first priority is to protect your well-being.

What’s in it for me?

This is a groundbreaking study for the health and well-being of people at risk for developing anal cancer. If we find that treating HSIL is effective at reducing risk for cancer, we anticipate a major shift in how medical providers care for their patients. We also expect insurance companies to start paying for HSIL screening and treatment. So, just like the brave HIV+ volunteers who helped in the development of life-saving HIV medications, you can have a similar impact on the health and longevity for others living with HIV. Also, since anal cancer disproportionately affects people with HIV, this study could allow some volunteers to express their social justice values. There are potentially several other reasons why you would feel good about your participation. No matter what your motivations are for entering this study, we believe all our study volunteers are heroes!

Will the study share any of my information with other organizations?

Your privacy is very important to us and we will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like gonorrhea. However, we will do our best to make sure your information will not identify you. Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database.