Joining the ANCHOR study involves several steps
Step 1. Fill out the Contact Form
Fill out the Online Contact Form or call our toll free number 1 844 HIV-BUTT (1 844 448-2888) if you would like to do it by phone instead. The contact form will ask you some screening questions to see if you are eligible for the study. If you are eligible, then we will contact you to tell you about the next information visit near you.
Step 2. The Information Visit
We would be honored to have you join our study. We also understand that this study is not for everyone and we want all our volunteers to make an informed decision about whether joining the study is right for them. The best way to learn about the study is to attend an information visit. This is a good time to ask a lot of questions and there may be others who may ask questions you didn’t realize you had. We encourage you to keep asking questions and you can call our toll free number 1 844 HIV-BUTT (1 844 448-2888) for answers.
Step 3. The Screening Visit
If you are still interested in joining the study after the information session, we will collect your contact information to schedule the next available screening visit. The screening visit will last approximately 2 hours. You will need to bring a document showing that you are HIV positive. At the screening visit, you will first read a document that details all the study procedures you can expect, the risks and benefits of being in the study, and how we will protect your privacy and confidentiality. If you agree to be screened, we will continue with the screening visit, which will consist of asking several questions about your medical and medication history. In addition, a study doctor will do some tests in a private room to see if you qualify for the study. You will change into a hospital gown and lie down on your side or face down. When you are ready, the doctor will insert and remove three small cotton swabs to collect samples of the skin cells. These swabs are called an "anal Pap" or "anal cytology." Then the doctor will use a gloved finger and some lube to feel just inside your anus for any lesions caused by HPV. This is called a digital anal rectal exam. Then the doctor will insert a small clear plastic anoscope in your anus, then a swab soaked in vinegar to make the HSIL more visible under the microscope. After removing the swab, the doctor will then use a microscope attached to a camera to look at the skin inside your anus for any signs of HSIL made visible by the vinegar. If found, the doctor will numb the area and take a biopsy of the lesion and send it to another specialist who will look at the biopsy under a microscope for signs of dysplasia. At the screening visit, the study team will also collect some blood samples. During the visit, the doctor will explain to you what they saw and whether they think you have any visible dysplasia. This is a good time to ask questions.
Step 4. Results of the Screening Visit
To diagnose HSIL, we need wait for the results of the biopsy to come back from the lab. This usually takes 2-6 weeks. As soon as we get the biopsy results, the study team will call you and let you know if you are eligible for the study.
Step 5. Enrollment Visit
If you are eligible, we will schedule your enrollment visit. At the enrollment visit, you will be checked again using the anoscope to check if the HSIL is still the same size as in the last visit. The doctor will use a computer program to randomly assign you, like flipping a coin, into either the active monitoring group or the treatment group. Neither you nor study staff can choose which group you are assigned to. You will take a questionnaire about risk factors for anal cancer. If you are assigned to the treatment group, the study doctor will discuss your preferred HSIL treatment options based on the size and location of the HSIL. Depending on which treatment you and the doctor decide to try, you will either get treated at that visit or take home some cream to use at home before bed.
Step 6. Next Visits
The timing of your next visit will depend on whether you are randomized to the treatment or monitoring group. Participants in the treatment arm will come back in a few weeks to check if the treatment worked and get another treatment if necessary. Participants in the active monitoring arm will come back in six months to have their HSIL checked. If at any time, your HSIL changes and looks like it might be developing into cancer, you will be immediately referred for cancer treatment.