Open Access Highly Accessed Study protocol

The Study of the Prevention of Anal Cancer (SPANC): design and methods of a three-year prospective cohort study

Dorothy A Machalek1, Andrew E Grulich1, Richard J Hillman2, Fengyi Jin1, David J Templeton13, Sepehr N Tabrizi456, Suzanne M Garland456, Garrett Prestage1, Kirsten McCaffery7, Kirsten Howard7, Winnie Tong8, Christopher K Fairley9, Jennifer Roberts10, Annabelle Farnsworth10, I Mary Poynten1* and on behalf of the SPANC study team

Author Affiliations

1 The Kirby Institute, The University of New South Wales, Sydney 2052, NSW, Australia

2 The Western Sydney Sexual Health Centre, University of Sydney, Westmead Hospital, Westmead 2145, NSW, Australia

3 RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown 2050, NSW, Australia

4 Regional HPV Labnet Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville 3052, Victoria, Australia

5 Murdoch Children's Research Institute, Parkville 3052, Victoria, Australia

6 Department of Obstetrics and Gynaecology, University of Melbourne, Parkville 3052, Victoria, Australia

7 School of Public Health, University of Sydney, Sydney 2006, NSW, Australia

8 Centre for Applied Medical Research, St Vincent's Hospital, Sydney 2010, NSW, Australia

9 Melbourne Sexual Health Centre and the School of Population Health, University of Melbourne, 580 Swanston Street, Carlton 3053, Victoria, Australia

10 Douglass Hanly Moir Pathology, 14 Giffnock Avenue, Macquarie Park 2113, NSW, Australia

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BMC Public Health 2013, 13:946  doi:10.1186/1471-2458-13-946

Published: 9 October 2013

Abstract

Background

The incidence of human papillomavirus (HPV)-associated anal cancer is increasing in men who have sex with men (MSM). Screening for the presumed cancer precursor, high-grade anal squamous intraepithelial lesions (HSIL) in a manner analogous to cervical cancer screening has been proposed. Uncertainty remains regarding anal HPV natural history and the role of anal cytology and high-resolution anoscopy (HRA) as screening tests. Well-designed cohort studies are required to address these issues.

Methods/design

The SPANC study is a prospective study of the epidemiology of low-risk and high-risk anal HPV infection and related cytological and histological abnormalities in HIV-negative and HIV-positive homosexual men aged 35 years and over. The study aims to recruit 600 men from community-based settings in Sydney, Australia. There are six study visits over three years. At the first five visits men undergo a digital ano-rectal examination (DARE), an anal “Papanicolaou” (Pap) test for HPV detection, genotyping and anal cytology, followed by HRA and directed biopsy of any visible abnormalities. The men also complete a behavioural questionnaire before each visit. Questions include a detailed history of sexual behaviour, of anal symptoms, possible anal cancer risk factors and validated quality of life and psychosocial questions. Questionnaires are also completed 2 weeks and 3 months following the provision of test results and include questions on participant experience during the procedure and post-procedure symptoms, including pain and bleeding in addition to quality of life/ psychosocial outcomes.

Discussion

Recruitment for the study began in September 2010 and will conclude in mid-2015, with follow up continuing to 2018. Thus far, over 350 men have been recruited from a variety of community-based settings and are broadly representative of the target screening population. The SPANC study is one of only a small number of cohort studies globally to perform HPV, cytology and HRA screening on all participants over multiple time points. The study results will contribute to understanding of the natural history of anal HPV and inform the possible development of guidelines for implementing anal cancer screening programs in this population.

Keywords:
Human papillomavirus; Anal cancer; Methods; Natural history; Men who have sex with men; Homosexual; Anal squamous cell carcinoma; HSIL/HGAIN; Precancerous conditions; Cancer screening