About The Study

The purpose of this study is to determine how effective treatment for anal dysplasia is compared to simply monitoring the condition. Specifically, HIV-positive men who have sex with men (MSM) who are found to have abnormal changes in the anal tissues (anal dysplasia, or pre-cancer) during a high-resolution anoscopy (HRA) test will be randomized to receive the treatment or remain under observation. This study follows the screening algorithm development study CTN 292A.

About The Disease

HPV is the most common sexually transmitted infection (STI) in the world and is the most common cause of anal cancer. HPV begins as an infection that may not cause any changes in the tissues, but can lead to anal dysplasia, a form of pre-cancer, and in some cases cancer. Pre-cancer is when there are abnormal cells or lesions that have the potential to turn cancerous. In HIV-positive men, the rates of anal HPV infection are very high, and these infections tend to persist longer in these men. As a consequence of the high HPV rates and higher persistence rates, the rates of anal cancer are much higher in HIV-positive men, particularly in men who have sex with men (MSM), compared to the general population. Unfortunately, there has not been enough research done for healthcare professionals to agree on a universal standard for screening for anal HPV, so anal dysplasia can be difficult to manage if detected.

Healthcare professionals are also unsure if treating dysplasia in anal tissues makes a difference in cancer rates. However, women with similar lesions in the cervix do benefit from treatments that get rid of the abnormal cells, usually through a process called ablation (removal of the upper layers of cells with an instrument that burns the area). Similar treatments are offered to men but there is no strong evidence to show that they make a difference in the long-term.

Study Approach

Participants who are found to have high-grade precancerous lesions during CTN 292A or who are screened and diagnosed independently in other clinics will be enrolled in this study. This is a prospective, open-label randomized controlled trial. Those who meet the criteria and choose to participate will be randomly placed into one of the two study groups:

  • Treatment Group: Will be treated with ablative therapy (electrocautery).
  • Surveillance Group: Will be actively monitored, but will not receive any treatment.

Participants will visit the clinic at 6 month intervals after baseline testing over a period of 36 months. The result of interest is the clearance of pre-cancerous lesions, and this will be compared between the treatment and surveillance groups. Ultimately, CTN 292 will help to optimize our approach to screening, preventing, and treating HPV-related anal disease in HIV-positive MSM.

Eligibility Requirements

Required

  • Males, aged 18 years or older at enrolment into 292A;
  • Identify as a man who has sex with men (MSM);
  • HIV-positive;
  • For those on combination antiretroviral therapy (cART), on a stable regimen
  • An ability to give informed consent;
  • An ability to attend clinic for follow up, including possible HRA and biopsy.
  • AIN-2 or -3 (appropriate grades of anal dysplasia) found on biopsy of anal canal lesion(s);
    Willingness to be randomized to undergo ablative therapy or active surveillance

For more information on inclusion and exclusion criteria, please refer to clinicaltrials.gov.

Not Allowed

  • Prior treatment of high grade anal dysplasia
  • Current or prior history of cancer of the anogenital regions (e.g. penile, anal, or rectal).

For more information on inclusion and exclusion criteria, please refer to clinicaltrials.gov

Additional Information

If you would like more information on this clinical study, please refer to Dr. Troy Grennan, one of the principal investigators, at 604-707-5606 (office).

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Participating Sites

Here’s where this study is being conducted.