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Co-infections and Concurrent Diseases (CCD)

CTNPT 023: the NOMAD Study

A pilot study of a novel, mRNA-based assay for the diagnosis of anal HPV infection HIV-positive MSM

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About the study

This study will examine the effectiveness, feasibility, and usefulness of a new test to detect cancer-causing human papillomavirus in the anal canal of HIV-positive men who have sex with men.

About the disease/condition

Squamous cell carcinoma (SCC) of the anal canal, a form of cancer, is more common in men who have sex with men (MSM), and even more so in those with HIV, compared to the general population. The primary cause of most anal SCC is the human papillomavirus (HPV). The increased occurrence of SCC in MSM living with HIV is thought to be due – at least in part – to an inability to clear HPV infections because of an impaired immune system.

Certain types of HPV can lead to pre-cancerous lesions which may develop into cancerous cells. Currently there is no standard, evidence-based method of screening, diagnosing, or treating precancerous lesions associated with HPV. A promising new technique (mRNA-based HPV assay) for detecting dangerous HPV has been developed but its usefulness has not been fully tested in HIV-positive MSM. This new detection technique utilizes messenger RNA – genetic material similar to DNA – to detect specific strains of HPV that are most likely to cause cancer.

Study Approach

CNTPT 023 will look at two different aspects of this technique: (1) the overall performance of this HPV test when using self-collected anal swabs and (2) compare the performance of self-collected versus clinician-collected sampling.

Participants will be taught how to perform the self-collection and given a detailed information sheet on the collection. During each study visit, both a self-administered and clinician-administered swab will take place in a randomized order. These samples will then be sent to a laboratory to be analyzed and the results compared. Study participants will also fill out a short questionnaire about the comfort and ease of doing their own swab.

Eligibility criteria

Inclusion criteria

  • Self-identified man who has sex with men
  • Age 18 years or older
  • Ability to communicate in both written and oral English
  • Laboratory documentation of HIV-1 infection;
  • An ability to give informed consent
  • An ability to attend clinic for study visit.

Exclusion criteria

  • Prior history of documented HGAIN (precancerous lesions) or any therapies (including chemical or cautery ablation, topical therapies, surgery) for dyplastic anal disease.

Participating sites

Hamilton, Ontario
Dr. Marek Smieja
Special Immunology Services Clinic at McMaster University Medical Centre

Additional Information

Principal Investigators

Dr. Troy Grennan
BC Centre for Disease Control
Tel: 604-707-5606

Dr. Mona Loutfy
University of Toronto / Women’s College Research Institute

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