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Co-infections and Related Conditions (CRC)


CTN 292A: Screening for high-grade anal dysplasia in HIV+ MSM

Development and validation of an anal cancer screening algorithm in HIV-positive men who have sex with men (MSM) – part of HPV-SAVE study.

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About the study

The purpose of this research study is to develop an effective method for determining which HIV-positive men who have sex with men (MSM) should receive a high-resolution anoscopy (HRA) examination to check for abnormal changes in the anal canal (anal dysplasia, or pre-cancer). This study looks to optimize decision making about HIV-positive MSM, through validation of the proposed anal cancer screening algorithm. Participants found to have high-grade dysplasia, described below, will be invited to enroll in CTN 292B which will compare the effectiveness of a surgical treatment versus observation alone for the condition.

About the disease/condition

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

The research team will recruit participants for the trial using an invitation from participating clinics that provide care to HIV-positive MSM. Three thousand MSM will receive an HPV test and an anal Pap smear to screen for signs of anal pre-cancer. Some of these participants will then be offered a high-resolution anoscopy (HRA) to check for more serious abnormal changes in the anal tissues.

By combining anal Pap smear and HPV testing, researchers will analyze the ability of these tests to identify individuals who need further testing. As mentioned, participants found to have high-grade dysplasia will be invited to participate in a treatment clinical trial, CTN 292B.

Eligibility criteria

Individuals will be eligible for the study if they meet the following inclusion criteria:

Required for the initial screening component of the study:

  • Males at least 18 years old
  • Identify as a man who has sex with men (MSM)
  • HIV-positive
  • For those on combination antiretroviral therapy (cART), on a stable regimen
  • Able to give informed consent
  • Able to attend the clinic for all study visits

Exclusion Criteria:

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

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

Participating sites

Toronto

Maple Leaf Medical Clinic,
St. Michael’s Hospital Positive Care Clinic,
St. Michael’s Hospital Health Centre at 410,
Sunnybrook Health Sciences Centre,
Toronto General Hospital Immunodeficiency Clinic,
Church Wellesley Health Centre,
the Clinic at 790 Bay Street.

Ottawa
The Ottawa Hospital HIV Clinic

Kingston
Kingston General Hospital

Vancouver
St Paul’s Hospital Immunodeficiency Clinic

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

Dr. Irving Salit, MDCM FRCPC
Toronto General Hospital, Toronto, ON

Dr. Troy Grennan, MD FRCPC
BC Centre for Disease Control, Vancouver BC

Publications

Grace D, Gaspar M, Paquette R, Rosenes R, Burchell AN, Grennan T, Salit IE. HIV-positive gay men’s knowledge and perceptions of Human Papillomavirus (HPV) and HPV vaccination: A qualitative study. Naanyu V, ed. PLoS ONE. 2018 Nov 29;13(11):e0207953.

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