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The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men (HPV-SAVE)

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ClinicalTrials.gov Identifier: NCT02503111
Recruitment Status : Enrolling by invitation
First Posted : July 20, 2015
Last Update Posted : September 15, 2016
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ontario HIV Treatment Network
CIHR Canadian HIV Trials Network
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Irving Salit, University Health Network, Toronto

Study Description
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Brief Summary:

Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal infection with these HR-HPV strains and the resultant high-grade anal dysplasia and anal cancer are much higher in men who have sex with men (MSM) than in the general population. Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer prior to the adoption of routine cervical cytology screening. Despite these alarming statistics, there are no established protocols for optimal screening and treatment of anal HPV and cancer precursors, nor has there been any widespread rollout of organized screening programs anywhere in Canada. Further, not only does HPV directly cause significant disease in these men, but there is growing epidemiologic evidence that HPV infection may enhance sexual transmission of HIV. These significant knowledge gaps translate into fundamental deficiencies in care for HIV-positive MSM.

The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team will recruit a large group of MSM to carry out a number of different studies. One key component of recruitment entails the mailing of invitations with educational materials in an invitational package to subjects in order to determine who would be interested in having anal cancer screening. In this way, the investigators will reveal factors that are important in acceptance of screening.

The HPV-SAVE team brings together community and internationally-recognized experts in HPV and HIV disease and mucosal immunology, to better define the optimal approaches for primary and secondary prevention and treatment of HPV-associated anal disease among HIV-positive MSM, and to explore biological mechanistic evidence regarding the potential role of HPV as a co-factor for HIV transmission. This will yield critical information which can lead to improvement in the health of MSM, and will provide a foundation on which to build further, large-scale screening and treatment trials on a national level.


Condition or disease Intervention/treatment Phase
Anal Dysplasia Human Papillomavirus Anal Cancer Device: The Hyfrecator ® 2000 Electrosurgical System Other: Observation Alone Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Randomized Controlled, Open-label Trial Examining the Efficacy, Safety, and Tolerability of Ablative Therapies for High-grade Anal Dysplasia Versus Observation Alone in HIV-positive Men Who Have Sex With Men (MSM)
Study Start Date : November 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ablative therapy
Ablative therapy involving electrocautery (EC) will occur for participants with AIN-2 and AIN-3. The Hyfrecator ® 2000 Electrosurgical System will be used for EC therapy.
 Device: The Hyfrecator ® 2000 Electrosurgical System
Lesion is ablated by the The Hyfrecator ® 2000 Electrosurgical System. During electrocautery (EC) with The Hyfrecator, a gentle brushing technique occurs and the tissue is removed with forceps.
Other Name: EC
Active Comparator: Active Surveillance
The control arm includes active surveillance with observation alone; no treatment in AIN-2 and -3.
 Other: Observation Alone
No treatment to AIN-2 or AIN-3, only active surveillance.


Outcome Measures
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Primary Outcome Measures :
  1. Anal dysplasia treatment on a per-patient basis [ Time Frame: Participants will be followed after post-treatment completion, an expected average of 6 months ]
    Histologic resolution of high-grade AIN after treatment completion, with ablative therapies or surveillance alone. Resolution of high-grade AIN will be defined as histologic diagnosis of AIN-1 or normal at the post treatment HRA.


Secondary Outcome Measures :
  1. Resolution of high-grade AIN at 3 and 6 months on a per-lesion basis [ Time Frame: Participants will be followed after post-treatment completion, an expected average of 6 months ]
    Resolution of high-grade AIN after treatment on a per-lesion basis. Histologic resolution of high-grade AIN after treatment completion, with ablative therapies or surveillance alone. Resolution of high-grade AIN will be defined as histologic diagnosis of AIN-1 or normal at the post treatment HRA.

  2. Acceptance rate of participants recruited into the study [ Time Frame: Participants will be followed after recruitment into the study, up to 4 years ]
    Acceptance rates of participant recruitment into the study via an invitational package for anal cancer screening which includes an invitation and educational brochure. Rates of acceptance will account for participants who positively respond to the invitational letter and reminder.

  3. Recurrence rates of high-grade AIN [ Time Frame: Participants will be followed after post-treatment completion, an expected average of 36 months ]
    Recurrence rates of high-grade AIN following ablative therapy on a per lesion basis.

  4. Number of participants with adverse events [ Time Frame: Participants will be followed after post-treatment completion, an expected average of 36 months ]
    Number of participants assessed on safety, tolerability and acceptability of the different intervention arms and the different treatments in the ablative therapies arms. Evaluation of adverse events and questionnaire-assessed acceptability by intervention arms and ablative treatment type.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males, aged ≥ years at baseline;
  • Identify as a man who has sex with a men (MSM);
  • Laboratory documentation of HIV-1 infection (enzyme-linked immunoassay and Western Blot);
  • For those on combination antiretroviral therapy, the participant must be on a stable regimen (i,e, virologically suppressed with HIV-1 RNA below the assay's limit of detection for a minimum of sex months).This is one attempt to minimize confounding from dramatic shifts in viral load and/or CD4 count;
  • An ability to give informed consent;
  • An ability to attend clinic for all study visits;
  • For those continuing to the treatment randomized controlled trial (RCT), AIN-2 or -3 found on biopsy of anal canal lesion(s), and willingness to undergo ablative therapy.

Exclusion Criteria:

  • Participants having previously undergone anal cancer screening;
  • Prior history of documented treatment of anal dysplasia;
  • Prior receipt of any HPV vaccine;
  • Current or prior history of cancer of the anogenital regions (e.g. penile, anal, or rectal);
  • Inability to consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503111


Locations
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Canada, British Columbia
BC Centre for Disease Control
Vancouver, British Columbia, Canada, V5Z 4R4
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z4
Canada, Ontario
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Ontario HIV Treatment Network
CIHR Canadian HIV Trials Network
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Irving Salit, MD Toronto General Hospital, University Health Network
More Information
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Publications:
Salit IE, Blitz S, Collins E, Aggarwal B, Raboud J, Tinmouth J, Kovacs C, Conway D, Hedgcock M, Merkley B, Fletcher D, Calzavara L. Anal cancer screening in HIV primary care: uptake and outcomes. Sex Health 2013;10(6): 588.

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Responsible Party: Irving Salit, Immunodeficiency Clinic Director, Toronto General Hospital, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02503111     History of Changes
Other Study ID Numbers: HPV-SAVE
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

Keywords provided by Irving Salit, University Health Network, Toronto:
Men who have sex with men
Human immunodeficiency virus
Human papillomavirus
Anal intraepithelial neoplasia
Squamous cell carcinoma
High-resolution anoscopy
Anal cancer
High-risk oncogenic
Intraepithelial lesion
 Low-risk non-oncogenic
Dysplasia
High-grade squamous intraepithelial lesion
Low-grade squamous intraepithelial lesion
Ablative therapy
Electrocautery
Infrared coagulation
Active surveillance

Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases